Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

Roche said on Thursday that first-half sales and profit fell as patients cut down on trips to hospital amid the COVID-19 pandemic although the Swiss drugmaker maintained its full-year outlook.

Roche maintains 2020 outlook as first-half sales, profit fall

Roche’s contributions to the fight against the COVID-19 pandemic in the second quarter:

First half of the year with 1%1 growth at constant exchange rates, significant impact of COVID-19 pandemic

Basel, 22 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from the phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of blindness globally.1 In Archway, 98.4% of PDS patients were able to go six months without needing additional treatment and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections, a current standard of care. In the study, PDS was generally well-tolerated, with a favourable benefit-risk profile.2 PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customised formulation of ranibizumab over a period of months. PDS is the first nAMD therapy to achieve positive phase III results for this extended length of time between treatments.3 These new data will be discussed virtually during the 38th Annual Meeting of the American Society of Retina Specialists (ASRS) on Sunday, 26 July 2020. A recorded presentation of these data is now available to ASRS attendees through the meeting web portal.  “Based on the Archway results, PDS could potentially reduce the number of treatments from as many as 12 per year to two per year for neovascular AMD patients, without sacrificing efficacy,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital in Philadelphia and an Archway study investigator. “While effective therapies exist for this condition, I know from clinical experience that it can be difficult for patients and caregivers to commit to frequent treatments, and patients who are not treated frequently enough may be at risk of losing vision.”  The current standard of care for nAMD requires patients to visit their ophthalmologist as often as monthly for eye injections of anti-vascular endothelial growth factor (VEGF) therapy to help maintain vision gains or prevent vision loss.4 This high treatment burden with anti-VEGF therapy can lead to under-treatment of nAMD and, potentially, less than optimal vision outcomes.4,5,6   “For over a decade, we have been working to develop new treatments that better address the unmet needs of people living with neovascular AMD,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Based on these data, we believe that the continuous delivery mechanism enabled by PDS may offer effective, reliable results while also alleviating the treatment burden. We are excited to share the data with regulatory authorities with the aim of bringing this new treatment option to patients as soon as possible.”  Patients in Archway received either PDS refilled every six months with a customised formulation of ranibizumab or monthly ranibizumab 0.5 mg eye injections. Patients in the study had received prior treatment with anti-VEGF therapy and were confirmed anti-VEGF responders. The primary endpoint of the study measured the change from baseline in best-corrected visual acuity averaged over Week 36 and Week 40. In the PDS arm, patients gained an average of 0.2 eye chart letters in visual acuity from baseline, with 98.4% (n=244/248) of patients maintaining the fixed six-month refill schedule within the first refill period. Patients treated monthly with ranibizumab injections gained an average of 0.5 letters in visual acuity from baseline. According to pre-specified study criteria, PDS was shown to be non-inferior and equivalent to monthly ranibizumab injections. In addition, PDS controlled retinal thickness as effectively as monthly ranibizumab, with patients in both arms achieving a mean change in center point thickness within 10 μm from baseline. Safety data from the study support a favourable benefit-risk profile for PDS. The PDS implant insertion surgery and refill-exchange procedures were generally well-tolerated by patients and the systemic safety of PDS was comparable to monthly ranibizumab injections.2   In addition to Archway, the Portal long-term extension study is investigating the long-term safety and tolerability of PDS for the treatment of nAMD.7 PDS is also being studied in the phase III Pagoda trial for the treatment of diabetic macular edema, a vision-threatening complication of diabetes.8 The Pagoda trial is actively recruiting patients.8  Results from the Archway study will be submitted to health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency, for consideration of regulatory approval for the treatment of nAMD.  About the Archway study 9 Archway (NCT03677934) is a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Port Delivery System with ranibizumab, refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab 0.5 mg, in 418 people living with neovascular age-related macular degeneration. Patients enrolled in Archway were responders to prior treatment with anti-vascular endothelial growth factor (VEGF) therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit. The primary endpoint of the study is the change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at the average of Week 36 and Week 40. Secondary endpoints include: safety; overall change in BCVA from baseline; and change from baseline in center point thickness at Week 36 and over time.   About neovascular age-related macular degeneration  Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss. It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.10 Worldwide, around 17 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the disease will affect even more people around the world as the global population ages.1,11,12   About Port Delivery System with ranibizumab  Port Delivery System with ranibizumab (PDS) is a permanent refillable eye implant, approximately the size of a grain of rice, which is designed to continuously release a customised formulation of ranibizumab into the eye over time. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that plays a critical role in the formation of new blood vessels and the leakiness of the vessels.13   PDS contains a customised formulation of ranibizumab not approved by regulatory authorities. It is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis®* (ranibizumab injection) which is approved to treat neovascular age-related macular degeneration (nAMD) and other retinal diseases.14   By maintaining therapeutic drug concentration levels of ranibizumab with two refills per year, PDS may offer greater outcomes certainty in terms of vision gains and maintaining those gains for people living with nAMD. Additionally, by decreasing the need for frequent injections and physician visits, PDS may reduce the burden of treatment associated with standard anti-VEGF treatments.4 The Archway study of PDS in nAMD is evaluating a regimen of PDS implantation followed by twice-yearly refills.  About Roche in Ophthalmology  Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.  Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss through Lucentis®* (ranibizumab injection) in 2006, the first treatment approved to improve vision in people with certain retinal diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), retinal vein occlusion (RVO) and myopic choroidal neovascularisation.14   With a robust pipeline, led by science and informed by insights from people with eye diseases, Roche has the broadest late stage retina pipeline, including treatments for nAMD, DME, DR and RVO. Our early stage pipeline also includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases, including rare and inherited conditions.3   About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.  Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.  Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).  The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit  www.roche.com .  *Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech  All trademarks used or mentioned in this release are protected by law.  References [1] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures [Internet; cited 2020 June 29]. Available from:  https://www.brightfocus.org/macular/article/age-related-macular-facts-figures . [2] Campochiaro, P, et al. Primary Analysis Results of the Phase 3 Archway Trial of the Port Delivery System With Ranibizumab for Patients With Neovascular AMD. American Society of Retina Specialists Annual Meeting; 2020 Jul 24-26. [3] Roche data on file. [4] Holz FG, et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. The British Journal of Ophthalmology. 2015;99:220-6. [5] Rao P, et al. Real-World Vision in Age-Related Macular Degeneration Patients Treated with Single Anti–VEGF Drug Type for 1 Year in the IRIS Registry. Ophthalmology. 2018;125:522-28. [6] European Medicines Agency. Summary of Product Characteristics for Lucentis 10 mg/ml solution for injection. [Internet; cited 2020 May 05]. Available from:  https://www.ema.europa.eu/en/documents/product-information/lucentis-epar-product-information_en.pdf . [7] ClinicalTrials.gov. Extension Study for the Port Delivery System With Ranibizumab (Portal) [Internet; cited 2020 June 29]. Available from:  https://clinicaltrials.gov/ct2/show/NCT03683251 . [8] ClinicalTrials.gov. This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab (Pagoda). [Internet; cited 2020 June 29]. Available from:  https://clinicaltrials.gov/ct2/show/NCT04108156 . [9] ClinicalTrials.gov. A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration (Archway) [Internet; cited 2020 June 29]. Available from:  https://clinicaltrials.gov/ct2/show/NCT03677934 . [10] Little K., et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration-the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91. [11] Wong WL, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014;2:106-16. [12] Pennington KL, et al. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34. [13] Wykoff, CC, et al. Optimizing anti-VEGF treatment outcomes for patients with neovascular age-related macular degeneration. Journal of Managed Care & Specialty Pharmacy, 2018; 24(2-a Suppl):S3-S15. [14] US Food and Drug Administration. Prescribing information: LUCENTIS (ranibizumab injection) for intravitreal injection [Internet; cited 2020 June 29]. Available from:  https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf .   Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com

Phase III data show Roche’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration

BOSTON--(BUSINESS WIRE)--Jnana collaboration with Roche to discover novel medicines targeting key regulators of cellular metabolism to treat immune-mediated neuro diseases

Jnana Therapeutics Enters Collaboration with Roche to Discover Novel Medicines that Target Key Regulators of Cellular Metabolism to Treat Immune-Mediated and Neurological Diseases

Novavax

The dynamics are completely different for these two healthcare stocks.

Better Buy: Novavax vs. Roche

SAN FRANCISCO--(BUSINESS WIRE)--PicnicHealth, the venture-backed startup that gives patients unprecedented access to their medical records and the ability to contribute to scientific research, is proudly announcing a strategic partnership with Roche and Genentech, a member of the Roche Group. PicnicHealth is gathering medical records data from proactively consenting patients, de-identifying it to ensure patient data privacy (HIPAA and CCPA compliant) and then aggregating it with the goal of dee

PicnicHealth Announces Strategic Partnership with Roche to Generate Scientific Insights from Real World Data

Blueprint Medicines

Roche is licensing commercial rights to Blueprint Medicines RET-inhibitor pralsetinib.

Blueprint Medicines Inks Deal With Roche Worth Up to $1.7 Billion

Blueprint Medicines (BPMC) signs a contract with Roche to commercialize pralsetinib for treating patients with RET-fusion NSCLC, RET-mutant MTC, other thyroid cancers and other solid tumors.

Blueprint Medicines, Roche to Develop Pralsetinib for Cancer

Blueprint Medicines Corp. (NASDAQ: BPMC) announced early on Tuesday that it had entered into a global collaboration with pharmaceutical giant Roche in which it may receive up to $1.7 billion.

What Does $1.7 Billion Mean to Blueprint Medicines?

Immunomedics

Immunomedics (IMMU) extends agreement with Roche to evaluate the combination of Trodelvy and Tecentriq in patients with mUC and mNSCLC.

Immunomedics Extends Deal With Roche for Two New Studies

Eli Lilly

Blueprint Medicines stock popped Tuesday on a $775 million deal with pharma giant Roche to sell a cancer treatment, pralsetinib. The drug targets abnormalities in the RET gene.

Could A $775 Million Roche-Blueprint Deal Unseat Eli Lilly In Cancer?

Shares of Blueprint Medicines Corp. BPMC, -2.93% gained 8.3% in premarket trading on Tuesday, the day after the company announced a deal with Roche Holding AG ROG, -1.66% to develop and commercialize pralsetinib, an investigational cancer drug.

Blueprint Medicines shares gain on deal with Roche

              Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other types of thyroid cancer, as well as other solid tumours. In addition, pralsetinib has demonstrated tumour-agnostic potential. The companies also plan to expand development of pralsetinib in multiple treatment settings and explore development of a next-generation RET inhibitor under the collaboration.  RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and MTC, and treatment options that selectively target these genetic alterations are limited. With the ongoing need for more targeted therapies that may offer clinical benefit to people with these types of cancers, this collaboration reflects Roche's strategy of providing treatments tailored specifically to a patient’s individual tumour profile and delivering truly personalised healthcare.  In lung cancer, pralsetinib will complement Roche’s broad portfolio of already approved medicines, alongside Alecensa, Rozlytrek, Tecentriq, Avastin and Tarceva and will further support our focus on understanding driver mutations in lung cancer through personalised treatment approaches. Beyond lung cancer, pralsetinib’s tumour-agnostic potential further expands Roche's ongoing commitment to finding new approaches to treat cancer in a more personalised way based on the genetic mutation of the disease, irrespective of the tumour site of origin.  “We are very excited to enter into this collaboration with Blueprint Medicines, a partner we have already been working with for four years, with the goal of bringing a potentially transformative treatment option to patients with rare RET-altered cancers as quickly as possible,” said James Sabry, Head of Roche Pharma Partnering. “In bringing pralsetinib to patients, we will leverage our global reach and expertise in oncology, as well as our capabilities in diagnostics and the use of real-world data toward our aim of providing personalised treatments for patients."  “With Roche’s global reach and unparalleled expertise in personalised healthcare, this collaboration will accelerate our ability to bring pralsetinib to patients with significant medical needs around the world and expand development of pralsetinib across multiple treatment settings where there is potential to benefit even broader patient populations,” said Jeff Albers, Chief Executive Officer of Blueprint Medicines.  Blueprint Medicines has submitted a new drug application (NDA) for pralsetinib to the US Food and Drug Administration (FDA) and a marketing authorisation application to the European Medicines Agency (EMA) for the treatment of RET fusion-positive NSCLC. The FDA granted priority review with an expected decision date of 23 November 2020. Blueprint Medicines has also submitted an NDA to the US FDA for RET mutation-positive MTC and RET fusion-positive thyroid cancer. The FDA has accepted the MTC application for its Real-Time Oncology Review (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.  Under the terms of the agreement, Blueprint Medicines will receive an upfront cash payment of $675 million and a $100 million equity investment in Blueprint Medicines’ common stock. In addition, Blueprint Medicines is eligible to receive up to $927 million in contingent development, regulatory and sales-based milestones, and royalties on net product sales outside the US. Roche and Blueprint Medicines will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US.   The closing of a minority portion of the equity investment is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions.   About RET-Altered Solid Tumours  RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC and approximately 10 to 20 percent of patients with papillary thyroid cancer, while RET mutations are implicated in approximately 90 percent of patients with advanced MTC. In addition, oncogenic RET alterations are observed at low frequencies in colorectal, breast, pancreatic and other cancers, and RET fusions have been observed in patients with treatment-resistant EGFR-mutant NSCLC.  About Pralsetinib  Pralsetinib is an investigational, once-daily oral precision therapy designed to selectively target RET alterations, including fusions and mutations, regardless of the tissue of origin. Preclinical data have shown that pralsetinib potently inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment. Blueprint Medicines is developing pralsetinib for the treatment of patients with RET-altered NSCLC, various types of thyroid cancer and other solid tumours.   About Roche in Oncology  Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.  The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa® (alectinib); Avastin® (bevacizumab); Cotellic® (cobimetinib); Erivedge® (vismodegib); Gazyva®/Gazyvaro® (obinutuzumab); Herceptin® (trastuzumab); Kadcyla® (trastuzumab emtansine); MabThera®/Rituxan® (rituximab); Perjeta® (pertuzumab); Polivy® (polatuzumab vedotin-piiq); Tarceva® (erlotinib); Rozlytrek® (entrectinib); Tecentriq® (atezolizumab); Venclexta®/Venclyxto® (venetoclax); Xeloda® (capecitabine); Zelboraf® (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies. For more information on Roche’s approach to cancer, visit www.roche.com.  About Roche in Personalised Healthcare  For more than 20 years, Roche has helped lay the scientific groundwork for personalised healthcare with treatments that target the underlying biology of cancer and other diseases. Now, with profound changes in data and technology transforming how medicines are discovered, developed and delivered to patients, we are uniquely positioned to extend this approach across all of healthcare. With our ability to integrate research and development, personalised diagnosis, disease monitoring and treatment access, we are advancing personalised healthcare for every aspect of the patient experience.  Our strategy is rooted in groundbreaking science that can accelerate drug discovery and development. We are also leveraging technologies such as real-world datasets, artificial intelligence, genomic profiling and digital health across our therapeutic portfolio, with an initial emphasis on oncology, neurology, ophthalmology and diagnostics. Through collaborations with academic institutions, industry partners, patients, physicians and regulatory agencies, our goal is to dramatically improve the performance of the entire healthcare ecosystem and the lives of every patient.  About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.  Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.  Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).  The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit  www.roche.com .  All trademarks used or mentioned in this release are protected by law and the property of their respective owners.  * Greater China encompasses Mainland China, Hong Kong, Macau and Taiwan.   Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com  - Nicolas Dunant (Head) - Patrick Barth - Daniel Grotzky - Karsten Kleine - Nina Mählitz - Nathalie Meetz - Barbara von Schnurbein

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers

CAMBRIDGE, Mass., July 14, 2020 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that it has entered into a global collaboration with Roche and...

Blueprint Medicines Announces Global Collaboration with Roche to Develop and Commercialize Pralsetinib for Patients with RET-Altered Cancers

Thanks to the introduction of drugs in three major disease areas, Roche (RHHBY) is expected to retain its position as the number one member of Big Pharma in terms of sales, according to a report from Evaluate Pharma.

Roche Forecasted to Be Top Drug Seller in 2026

Roche's (RHHBY) phase III study on Tecentriq in combination with Avastin fails to meet its primary goal.

Roche's (RHHBY) Tecentriq Disappoints in Ovarian Cancer Study

              Basel, 13 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the second interim analysis of the phase IIIb STASEY study, which reinforce the safety profile of Hemlibra® (emicizumab) characterised in the phase III HAVEN clinical programme.1,2,3 In the STASEY study, Hemlibra was effective with no new safety signals identified in adults and adolescents with haemophilia A with factor VIII inhibitors, which was consistent with previous safety observations.1 Further new interim data suggest that people on Hemlibra may be able to undergo certain minor surgeries without additional preventative (prophylactic) coagulation factor.4 These data were presented at the International Society on Thrombosis and Hemostasis (ISTH) 2020 Virtual Congress, 12-14 July 2020.  “These important safety data continue to add to the extensive clinical evidence reinforcing Hemlibra’s potential to redefine the standard of care for people with haemophilia A,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “The STASEY study reflects our continued focus on providing valuable insights that meet the needs of the haemophilia community and enhance our understanding of Hemlibra in clinical practice.”  The second interim analysis of the STASEY study included data from 193 patients with haemophilia A with factor VIII inhibitors, who received Hemlibra prophylaxis once-weekly.1 No cases of thrombotic microangiopathy or serious thrombotic events (TEs) related to Hemlibra were reported, and no new safety signals were observed.1 Thirty-three (17.1%) people reported a Hemlibra-related adverse event (AE).1 The most common AEs, occurring in 10% or more of people in the STASEY study, were common cold symptom nasopharyngitis (12.4%), headache (11.9%) and injection-site reaction (ISR) (11.4%).1 The ISRs reported were either mild or moderate in severity and no patients discontinued due to ISR.1 Annualised bleed rates (ABR) were also consistent with previously reported observations from the phase III HAVEN studies.1,2,3   A separate analysis described management and outcomes of minor and unplanned major surgeries in patients receiving Hemlibra, although not a formal surgery endpoint in STASEY. Results suggest people with haemophilia A with factor VIII inhibitors who undergo certain minor surgeries whilst receiving Hemlibra may not need additional preventative coagulation factor.4  The majority of minor surgeries (n=20/31) were performed without the use of preventative coagulation factor (64.5%) and, of these, 85% (n=17/20) did not result in treated post-operative bleeds.4 Of the unplanned major surgeries (n=9), eight were managed with prophylactic coagulation factor, four of which resulted in bleeds managed successfully with recombinant factor VIIa.4 These findings are consistent with results observed in a previous analysis of surgeries in the pivotal HAVEN studies.5    STASEY is a single-arm, multicentre, open-label, phase IIIb clinical study where patients received Hemlibra for an average of 50.9 weeks. The ABR of all bleeds, including treated bleeds, treated spontaneous bleeds, treated joint bleeds and treated target joint bleeds were low, with 167 patients (85.6%) experiencing zero treated bleeds.1 In the STASEY study there were two TEs unrelated to Hemlibra reported. One was a ST-elevation myocardial infarction in a person with pre-existing risk factors, which the treating physician assessed as unrelated to Hemlibra.1 The second was a hypertrophic clot at the site of a tooth extraction, a known complication of the procedure.1   Hemlibra is approved to treat people with haemophilia A with factor VIII inhibitors in more than 90 countries worldwide and for people without factor VIII inhibitors in more than 70 countries worldwide, including the US, EU and Japan. Hemlibra has been studied in one of the largest clinical trial programmes in people with haemophilia A with and without factor VIII inhibitors, including five completed phase III studies. The STASEY study is the largest open-label study primarily assessing the safety and tolerability of a medicine for people with haemophilia A with factor VIII inhibitors.  About Hemlibra® (emicizumab) Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly, every two weeks or every four weeks (after an initial once-weekly dose for the first four weeks). Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh), with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the US Food and Drug Administration.  About haemophilia A  Haemophilia A is an inherited, serious disorder in which a person’s blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 320,000 people worldwide,6,7 approximately 50-60% of whom have a severe form of the disorder.8 People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their disorder, people with haemophilia A can bleed frequently, especially into their joints or muscles.6  These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility, and long-term joint damage.9 A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies.10 Inhibitors are antibodies developed by the body’s immune system that bind to and block the efficacy of replacement factor VIII,11 making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding.   About Roche in haematology  Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.  About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.  Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.  Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).  The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit  www.roche.com .  All trademarks used or mentioned in this release are protected by law.  References [1] Jimenez-Yuste V et al. Second Interim Analysis Results from STASEY Trial: A Single-arm, Multicenter, Open-Label, Phase III Clinical Trial to Evaluates the Safety and Tolerability of Emicizumab Prophylaxis in People with Hemophilia A (PwHA) with FVIII inhibitors. [poster no. PB0958] International Society on Thrombosis and Haemostasis (ISTH) 2020 Congress, 12-14 July, 2020 [2] Oldenburg J et al. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. NEJM 2017; 377:809-818 [3] Young G et al. Emicizumab prophylaxis provides flexible and effective bleed control in children with hemophilia A with inhibitors: results from the HAVEN 2 study. Blood 2018; 132 (Supplement 1):632 [4] Castaman G et al. Surgical Experience from the Phase III STASEY Trial of Emicizumab Prophylaxis in Persons with Hemophilia A (PwHA) with FVIII Inhibitors: Data from the Second Interim Analysis. [poster no: PB0939] International Society on Thrombosis and Haemostasis (ISTH) 2020 Congress, 12-14 July, 2020 [5] Santagostino E et al. Surgical experience from four phase III studies (HAVEN 1–4) of emicizumab in persons with haemophilia A (PwHA) with or without FVIII inhibitors. [OC 60.1] Nurses and Orals Abstracts. Res Pract Thromb Haemost 2019; 3:1-228 [6] WFH. Guidelines for the management of haemophilia. 2012 [Internet; cited July 2020]. Available from:  http://www1.wfh.org/publications/files/pdf-1472.pdf   [7] Berntorp E et al. Modern haemophilia care. The Lancet 2012; 370:1447-1456 [8] Marder VJ et al. Hemostasis and Thrombosis. Basic Principles and Clinical Practice. 6th Edition, 2013. Milwakee, Wisconsin. Lippincott Williams and Wilkin [9] Franchini M et al. Haemophilia A in the third millennium. Blood Rev 2013; 179-84 [10] Gomez K et al. Key issues in inhibitor management in patients with haemophilia. Blood Transfus. 2014; 12:s319-s329 [11] Whelan SF et al. Distinct characteristics of antibody responses against factor VIII in healthy individuals and in different cohorts of haemophilia A patients. Blood 2013; 121:1039-48   Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com  - Nicolas Dunant (Head) - Patrick Barth - Daniel Grotzky - Karsten Kleine - Nina Mählitz - Nathalie Meetz - Barbara von Schnurbein

New data from phase IIIb study reinforces safety profile of Roche’s Hemlibra in people with haemophilia A

Basel, 13 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer. Topline safety data indicate that safety for Tecentriq in combination with Avastin, paclitaxel and carboplatin was consistent with the known safety profile of the combination.   “Ovarian cancer remains one of the most aggressive cancers and is difficult to treat in its advanced stages,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “While we are disappointed by these results, we remain committed to improving outcomes for women living with this disease and are pleased that Avastin remains a key component in the treatment of front-line ovarian cancer.”   Data for the overall survival (OS) co-primary endpoint are currently immature and follow-up will continue until the next planned analysis. Results from IMagyn050 will be further evaluated in order to inform the Tecentriq gynaecologic development programme. The Tecentriq programme in ovarian cancer and cervical cancers builds on the combination with Avastin, which has helped women with newly diagnosed, advanced or relapsed ovarian and cervical cancers live without their disease getting worse, as demonstrated in results across seven pivotal Phase III trials that involved more than 5,000 women.  Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.  About the IMagyn050 study  IMagyn050 is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy and safety of Tecentriq in combination with Avastin, paclitaxel and carboplatin compared with placebo plus Avastin, paclitaxel and carboplatin in women with Stage III or IV ovarian cancer who are undergoing neoadjuvant or adjuvant therapy. Patients were randomised 1:1 either before or after tumour reductive surgery. The co-primary endpoints are investigator-determined PFS and OS, both in the intent-to-treat (ITT) population and PD-L1-positive subpopulation. Key secondary endpoints include objective response rate, safety and tolerability, as well as patient-reported improvement in abdominal pain and bloating.   The IMagyn050 study is being conducted in collaboration with The GOG Foundation, Inc. (GOG Foundation) [GOG-3015] and the European Network of Gynaecological Oncological Trial groups (ENGOT) [ENGOT OV-39].  About ovarian cancer  Ovarian cancer is the 8th most commonly occurring cancer in women worldwide, with nearly 300,000 new cases diagnosed each year.1,2 Ovarian cancer remains the leading cause of death from any gynaecologic malignancy, due to the fact that the majority of patients are not diagnosed until they present with already advanced stage disease, resulting in a 5-year survival rate of less than30%.3,4   About Tecentriq  Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.  Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer and in PD-L1-positive metastatic triple-negative breast cancer. In the US, Tecentriq in combination with Avastin is approved for people with unresectable or metastatic hepatocellular carcinoma.  About Avastin  Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).  About Roche in cancer immunotherapy  Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.  In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:  http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm    About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.  Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.  Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).  The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit  www.roche.com .  All trademarks used or mentioned in this release are protected by law.  References [1] World Health Organization: Globocan 2018 – Ovarian Cancer Factsheet. [Internet; cited 20 April 2020] Available from:  https://gco.iarc.fr/today/data/factsheets/cancers/25-Ovary-fact-sheet.pdf .[2] World Cancer Research Fund. Ovarian Cancer Statistics. [Internet; cited 20 April 2020] Available from:  https://www.wcrf.org/dietandcancer/cancer-trends/ovarian-cancer-statistics .[3] American Cancer Society. What Is Ovarian Cancer? [Internet; cited 20 April 2020] Available from:  https://www.cancer.org/cancer/ovarian-cancer/about/what-is-ovarian-cancer.html .[4] Cancer.Net. Ovarian, Fallopian Tube, and Peritoneal Cancer: Statistics. [Internet; cited 20 April 2020] Available from:  https://www.cancer.net/cancer-types/ovarian-fallopian-tube-and-peritoneal-cancer/statistics .

Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer

Merck

The European Commission has reached agreements with pharmaceutical companies Roche and Merck KGaA to supply experimental drugs that can be used to treat COVID-19 patients, a commission source told Reuters on Wednesday.

Exclusive: EU reaches deals with Roche, Merck for supply of COVID-19 drugs - source

Roche (RHHBY) receives FDA approval for a fixed-dose combination of Perjeta and Herceptin, Phesgo, plus chemotherapy as a treatment for HER2-positive breast cancer.

Roche's SC Formulation of Perjeta-Herceptin Combo Gets FDA Nod

              Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Phesgo™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.  “The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options.”  Phesgo is available in one single-dose vial. Administration can take approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. [1] This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines. [2, 3]  Phesgo can be administered by a healthcare professional in a treatment centre or at a patient’s home.  The approval is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint with Phesgo showing non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhoea and anaemia. [1, 4]   The phase II PHranceSCa study showed that 85% (136/160) of people receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration. [1]   About the FeDeriCa study [4, 5]  FeDeriCa is an international, multi-centre, two-arm, randomised, open-label, pivotal phase III study evaluating the pharmacokinetics, efficacy and safety of subcutaneous injection of Phesgo in combination with chemotherapy, compared with standard intravenous (IV) infusions of Perjeta and Herceptin in combination with chemotherapy, in 500 people with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta. Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pathological complete response, meaning there is no tumour tissue detectable in the tissue removed at the time of surgery.   Data from the FeDeriCa study were presented at the San Antonio Breast Cancer Symposium in December 2019. The FeDeriCa study met its primary endpoint of non-inferior levels of Perjeta in the blood. The geometric mean ratio (GMR; a type of average used when assessing pharmacokinetics) for the primary endpoint was 1.22 (90% CI: 1.14 to 1.31), with the lower limit of the 90% CI of the GMR=1.14≥0.80 (the pre-specified non-inferiority margin). A secondary endpoint of non-inferior levels of Herceptin was also met, with blood concentrations for people receiving the fixed-dose combination non-inferior to those receiving IV Herceptin (GMR=1.33 [90% CI: 1.24 to 1.43]; lower limit of 90% CI of GMR=1.24≥0.80). A non-inferiority endpoint was chosen for the study to ensure that people were receiving sufficient dosing with Perjeta and Herceptin as compared to the established IV doses at the same treatment intervals.   About the PHranceSCa study [6]  PHranceSCa is a phase II, randomised, multi-centre, multinational, open-label, cross-over study evaluating patient preference for and satisfaction with subcutaneous administration of Phesgo in 160 people with HER2-positive early breast cancer. All patients completed neoadjuvant (before surgery) treatment with Perjeta, Herceptin and chemotherapy and had surgery before randomisation. The primary endpoint of the study is the percentage of participants who indicate that they prefer treatment with Phesgo compared to the standard intravenous (IV) formulations of Perjeta and Herceptin. Secondary endpoints include participant-reported satisfaction and health-related quality of life outcomes; healthcare professionals' perceptions of time and resource use and convenience compared with IV formulations; as well as the safety and efficacy of each study regimen.   Interim results from the PHranceSCa study were presented at the European Society for Medical Oncology Breast Cancer Virtual Meeting in May 2020. Primary results will be presented at a medical conference later in 2020.  About Phesgo  Phesgo is a new fixed-dose subcutaneous (SC) formulation that combines Perjeta and Herceptin with Halozyme Therapeutics’ Enhanze® drug delivery technology. [1] This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.   Halozyme’s Enhanze drug delivery technology may enable and optimise SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – to aid in the dispersion and absorption of other injected therapeutic drugs. [7]   Pertuzumab in Phesgo is the same monoclonal antibody as in intravenous (IV) Perjeta, and trastuzumab in Phesgo is the same monoclonal antibody as in IV Herceptin. The mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but in different locations. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signalling pathways. [8, 9]   The standard IV formulation of Perjeta in combination with IV Herceptin and chemotherapy (the Perjeta-based regimen) is approved in over 100 countries for the treatment of both early and metastatic HER2-positive breast cancer. In the neoadjuvant (before surgery) early breast cancer (eBC) setting, the Perjeta-based regimen has been shown to almost double the rate of pathological complete response compared to Herceptin and chemotherapy. [10] Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) eBC setting. [11] In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer. [12]   About Roche’s medicines for HER2-positive breast cancer  Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and metastatic HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients. [13] Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla® (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test which identifies people who will likely benefit from these medicines at the onset of their disease.  About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.  Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.  Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).  The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit  www.roche.com .  All trademarks used or mentioned in this release are protected by law.  References [1] US Food and Drug Administration. Prescribing information for Phesgo.  [2] US Food and Drug Administration. Prescribing Information for Herceptin. [Internet; cited June 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf.  [3] US Food and Drug Administration. Prescribing Information for Perjeta [Internet; cited June 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf.  [4] Tan A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS, 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07.  [5] Clinical trials.gov. A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer (FeDeriCa). [Internet; cited June 2020]. Available from: https://clinicaltrials.gov/ct2/show/NCT03493854. [6] Clinical trials.gov. A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer (PHranceSCa). [Internet; cited June 2020]. Available from: https://clinicaltrials.gov/ct2/show/NCT03674112. [7] Halozyme. Enhanze® Drug Delivery Technology. [Internet; cited June 2020]. Available from: https://www.halozyme.com/enhanze/overview/default.aspx. [8] Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;2014:852748. [9] Baselga J, Swain SM. Novel anticancer targets: revisiting ERBB2 and discovering ERBB3. Nat Rev Cancer 2009;9:463-75. [10] Gianni L, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25-32.  [11] Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;13;377(2):122-31. [12] Swain SM, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;19;372(8):724-34. [13] Wolff AC, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997-4013.   Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com   - Nicolas Dunant (Head) - Patrick Barth - Daniel Grotzky - Karsten Kleine - Nathalie Meetz - Barbara von Schnurbein

FDA approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer

Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its haemophilia A clinical programme will be presented at the International Society on Thrombosis and Haemostasis (ISTH) 2020 Congress on 12-14 July 2020. Data will include updated safety results from the phase IIIb STASEY study of Hemlibra® (emicizumab) and new results from the phase III HAVEN 5 study of Hemlibra. Data will also include insights into the impact of living with haemophilia A. Spark Therapeutics (a member of the Roche Group) will also present data from the initial dose cohorts of its phase I/II SPK-8011 gene therapy study.  “We are excited to share updated data from our combined haemophilia A programme at this year’s virtual ISTH 2020,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “These data exemplify our efforts to increase our knowledge and capabilities in haemophilia A, including in the context of gene therapy, with the goal of advancing care and providing innovative treatment approaches for people living with this chronic condition.”  SPK-8011 data presentation  Data from the initial dose cohorts of Spark’s phase I/II SPK-8011 gene therapy study in haemophilia A will be presented at the congress. Updated data from five participants in the initial dose cohorts, who are up to 142 weeks post-vector infusion, show stable and durable factor VIII expression and a 91% reduction in annualised bleed rate (ABR). There is no evidence of decline in factor VIII expression after more than two years of follow up.1  These data indicate an acceptable safety profile, with no development of factor VIII inhibitors. Furthermore, they represent the longest stable expression of factor VIII following gene transfer and support the use of adeno-associated virus-mediated (AAV-mediated), liver directed gene therapy to achieve durable factor VIII expression for the treatment of haemophilia A.1   Key Hemlibra data presentations  Data for Hemlibra will be featured in four poster presentations at the congress. This further supports the comprehensive body of clinical evidence available for Hemlibra, including from the HAVEN studies – the most extensive clinical development programme in haemophilia A. This includes results from the second interim analysis of the phase IIIb STASEY study, evaluating the safety and tolerability of Hemlibra prophylaxis in people with haemophilia A with factor VIII inhibitors.  Further data from the STASEY study to be presented outline surgical experiences in the trial, as well as additional insights into the pharmacokinetics and pharmacodynamics profile of Hemlibra.  Roche will also share the first clinical data from the phase III HAVEN 5 study, evaluating the efficacy, safety and pharmacokinetics of Hemlibra in 70 people with haemophilia A with and without factor VIII inhibitors in the Asia-Pacific region. The study met its primary endpoint, demonstrating that Hemlibra prophylaxis dosed every week or every four weeks resulted in a statistically significant 96% (p

Roche announces new data at the ISTH 2020 Congress, demonstrating ongoing commitment to advancing care for people with haemophilia A

              Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children. ENSPRYNG demonstrated robust efficacy and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to baseline immunosuppressant therapy (IST), and is dosed subcutaneously every four weeks.  NMOSD is commonly associated with pathogenic antibodies (AQP4-IgG) that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain. AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of NMOSD patients, and these patients tend to experience a more severe disease course. Although most cases of NMOSD can be confirmed through a diagnostic test, up to 30% of people living with the condition are still frequently misdiagnosed with multiple sclerosis.  “Today’s approval in Japan is the first for ENSPRYNG in Asia, providing a new treatment option to help reduce NMOSD relapses that cause irreversible disability, such as vision loss and paralysis,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Japan has a high prevalence of NMOSD in both adults and children, but limited approved treatment options. ENSPRYNG offers robust efficacy, is well-tolerated, and is the first and only approved therapy targeting the interleukin-6 (IL-6) receptor given subcutaneously every four weeks.”  ENSPRYNG is a humanised monoclonal antibody that targets the IL-6 receptor, believed to play a key role in the inflammation that occurs in people with NMOSD. ENSPRYNG was designed by Chugai Pharmaceutical Co., a member of the Roche group, using novel antibody recycling technology. Compared to conventional technology, this allows for longer duration of antibody circulation and maximum inhibition of IL-6 signalling, while minimising safety risks in a chronic disease setting.  People with NMOSD experience unpredictable, severe relapses directly causing cumulative, irreversible neurological damage and disability. Preventing relapses through early treatment can have a positive impact on preventing disability and is the primary goal for NMOSD disease management.  ENSPRYNG was recently approved in Canada under priority review, as a monotherapy or as an add-on therapy to baseline IST, for the treatment of NMOSD in adult and adolescent patients who are AQP4-IgG seropositive. In October 2019, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) accepted the marketing applications for ENSPRYNG for the treatment of NMOSD. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation and the FDA decision are expected in 2020. In April 2020, China’s Centre for Drug Evaluation (CDE) accepted a licensing application for ENSPRYNG.  The approval of ENSPRYNG in Japan is based on data including the two pivotal Phase III studies, SAkuraStar and SAkuraSky, evaluating the efficacy and safety of ENSPRYNG as a monotherapy and as an add-on therapy to baseline IST, respectively.

Roche’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder

Basel, June 26, 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD launch of its automated digital pathology algorithm, the uPath PD-L1 (SP263) image analysis for non-small cell lung cancer (NSCLC). The algorithm provides pathologists with automated assessments of scanned slide images that are objective and reproducible and have the potential to aid diagnosis and, ultimately, targeted treatment options for patients.   Validated on the VENTANA PD-L1 (SP263) Assay, the algorithm is ready-to-use and integrated within the Roche uPath enterprise software, a universal digital platform for case management, collaboration and reporting. This algorithm will help pathologists to quickly determine whether tumours are positive for the PD-L1 biomarker, highlighting positively and negatively stained tumour cells with a clear visual overlay for easy reference. Patients with tumours that are positive for the PD-L1 biomarker may be eligible for targeted treatment.  “Improving diagnostic consistency and certainty is crucial in providing faster, higher-quality and more accurate diagnoses to cancer patients,” said Thomas Schinecker, CEO, Roche Diagnostics. “Our uPath PD-L1 (SP263) image analysis for non-small cell lung cancer is the first next-generation CE-IVD PD-L1 algorithm to the clinical market. It expands on our growing digital pathology suite for VENTANA assays that aid physicians in providing the most accurate treatment decisions for patients with the most common type of lung cancer.”  The algorithm’s whole-slide automated analysis uses artificial intelligence to provide, with one-click, an actionable assessment of the scanned slide images that is objective and reproducible. The uPath PD-L1 (SP263) image analysis (NSCLC) algorithm for digital pathology is for use on uPath enterprise software.  About uPath image analysis algorithm suite The uPath image analysis algorithm suite for pathology decision support offers ready-to-use image analysis tools, providing fast, consistent and automated analysis so that pathologists can quickly, accurately and confidently assess immunohistochemistry/in situ hybridization and hematoxylin and eosin-stained slides. This launch of uPath PD-L1 (SP263) image analysis for non-small cell lung cancer follows the January 2019 release of the Roche uPath enterprise software. All algorithms in the suite for uPath software will provide image analysis of VENTANA DP 200 scanned slide images stained with a Roche tissue assay. Together, Roche is delivering a new foundation of its digital pathology solution which will enable the development of artificial intelligence-based image analysis algorithms that can provide pathologists more tools to improve efficiency and precision.  Roche is delivering the end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated clinical image analysis algorithms. Roche minimizes the variables that can impact analysis, and it is this end-to-end development that produces the quality results customers can depend on for making clinical decisions. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented tools into routine clinical practice.  About the uPath PD-L1 (SP263) image analysis for NSCLC algorithm  The uPath PD-L1 (SP263) image analysis for NSCLC algorithm is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of PD-L1 protein in formalin-fixed, paraffin-embedded NSCLC tissue. When used with the CE-marked VENTANA PD-L1 (SP263) Assay, it is indicated for use as an aid in identifying patients for treatment with therapies with the ≥ 50% PD-L1 TC positivity cutoff in accordance with the approved therapeutic product labeling. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape.  About non-small cell lung cancer Lung cancer is the leading cause of cancer death globally.1 Each year, 1.76 million people die as a result of the disease, translating into more than 4,800 deaths worldwide every day.1 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for about 85% of all cases.2 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.2   About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.  Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.  Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).  The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit  www.roche.com .  VENTANA and UPATH are trademarks of Roche. Other product names and trademarks are the property of their respective owners.  References [1] World Health Organization. GLOBOCAN 2018; Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. Available from: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed November 2019. [2] American Cancer Society. What Is Non-Small Cell Lung Cancer? [Internet]: Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed November 2019.

Roche improves speed and accuracy of non-small cell lung cancer diagnosis with launch of automated digital pathology algorithm

      ·Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and prednisone/prednisolone alone) plus placebo met its co-primary endpoint of radiographic progression free survival (rPFS) in patients with PTEN loss tumours   Basel, 19 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumours had PTEN loss. In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. The other co-primary endpoint of rPFS in the overall study population (ITT) was not met. The safety profile for the combination of ipatasertib and abiraterone was consistent with previous analyses and known risks. The results of the IPATential150 study will be presented at an upcoming medical meeting.  While initial data are encouraging, overall survival benefit and additional secondary endpoints are not yet mature. The trial will continue until the next planned analysis and data will be shared with health authorities.  “Prostate cancer remains a leading cause of death in men worldwide and patients with metastatic castration-resistant prostate cancer can be difficult to treat,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The early results of the IPATential150 study are encouraging in our ongoing mission to develop new treatment options for people with advanced prostate cancer.”  Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT (protein kinase B), which blocks the PI3K/AKT signalling pathway – a key driver of cancer cell growth and proliferation in prostate cancer.1,2 The PI3K/AKT pathway has also been implicated in resistance to anti-androgen therapy as androgen receptor (AR) inhibition is associated with an increase in AKT pathway activation.2,3 Functional loss of the tumour suppressor protein PTEN within the tumour, seen in approximately 40-60% of mCRPC patients, results in hyperactivation of the PI3K/AKT pathway and is associated with adverse outcomes such as increased tumour grade and stage, earlier biochemical recurrence after radical prostatectomy, metastasis, prostate-cancer-specific death, and androgen-independent progression.4,5   Roche’s clinical development programme for ipatasertib focuses on tumours that are frequently found to have activation of the PI3K/AKT pathway. In addition to prostate cancer, ipatasertib is being studied in certain types of breast cancer including triple-negative breast cancer (TNBC) and hormone-receptor positive (HR+), HER2- negative breast cancer. Results are anticipated later in 2020.  About the IPATential150 study6   IPATential150 is a double-blind, placebo-controlled, randomised phase III study assessing ipatasertib in combination with abiraterone and prednisone/prednisolone, compared to placebo plus abiraterone and prednisone/prednisolone, in adult male patients with asymptomatic or mildly symptomatic, previously untreated mCRPC.  The co-primary endpoints of the study are investigator-determined rPFS in the overall study population, as well as a subpopulation whose tumours have PTEN loss, as assessed by immunohistochemistry (Ventana assay). PFS in the study is defined as the time from date of randomisation to the first occurrence of disease progression or death from any cause, whichever occurs earlier. Secondary endpoints include overall survival, safety, time to pain progression, time to initiation of cytotoxic chemotherapy and time to function deterioration.  About ipatasertib  Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT, which blocks the PI3K/AKT signalling pathway and may prevent cancer cell growth and survival.1,2   Ipatasertib is being studied in tumours that are frequently found to have activation of the PI3K/AKT pathway, including breast and prostate cancers. Clinical studies are ongoing to evaluate the efficacy and safety of ipatasertib and the opportunity it may provide to address significant unmet needs for patients with these diseases.  Ipatasertib was discovered at Genentech in partnership with Array BioPharma Inc. (acquired by Pfizer Inc. on July 30, 2019).  About metastatic castration-resistant prostate cancer (mCRPC)  Prostate cancer is the second most frequent cancer and the fifth leading cause of death in men.7 Metastatic prostate cancer refers to prostate cancer that has spread beyond the prostate to other parts of the body (metastasised).8 Although most men are cured with treatment of localised disease, recurrent or newly diagnosed metastatic disease is associated with significant morbidity and mortality.9,10,11   Primary treatment of advanced prostate cancer is androgen deprivation therapy (ADT); however, up to one-third of patients will progress despite reduction in serum testosterone levels to castrate levels (

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