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.

Despite multiple patent expirations of some of its key drugs, including Avastin, Herceptin, and Rituxan, Roche, one of the largest pharmaceutical companies with a market capitalization of close to $300 billion, saw its sales increase from $53.2 billion in 2016 to $64.4 billion in 2019.

What’s The Buzz About Roche’s New Drugs?

BALTIMORE, Oct. 1, 2020 /PRNewswire/ -- Tamiflu-maker Hoffman-La Roche (OTCMKTS – RHHBY) must answer to whistleblower charges that it falsified claims of Tamiflu's effectiveness in fighting influenza and fraudulently induced the federal government to stockpile millions of doses for a...

Judge Rules Tamiflu-Maker Hoffman-La Roche Must Answer Whistleblower Fraud Claims

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi™ (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) showed that they continued to improve and achieve motor milestones. This exploratory analysis showed that an estimated 88

Genentech Presents New 2-Year Data for Evrysdi (risdiplam) in Infants With Type 1 Spinal Muscular Atrophy (SMA)

Basel, 28 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new 2-year data from Part 1 of the pivotal FIREFISH study of Evrysdi™ (risdiplam) in infants aged 2-7 months with symptomatic Type 1 spinal muscular atrophy (SMA). The 2-year results in infants treated with the therapeutic dose of Evrysdi (17/21) showed that they continued to improve and achieve motor milestones.   This exploratory analysis showed that an estimated 88% of infants were alive and required no permanent ventilation at two years. In addition, at two years, 59% (10/17 vs. 7/17 at 1-year) of infants were able to sit without support for at least 5 seconds, assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development – Third Edition (BSID-III). Sixty-five percent (11/17 vs. 9/17 at 1-year) had maintained upright head control, 29% (5/17 vs. 2/17 at 1-year) could turn themselves over and 30% (5/17 vs. 1/17 at 1-year) were able to stand either supporting weight or with support. After two years of treatment with Evrysdi, 71% (12/17 vs. 10/17 at 1-year) of infants achieved a CHOP-INTEND* score of 40 points or more and all infants increased their score from month 12 to month 24. Of the infants alive at two years (n=14), 100% maintained the ability to swallow and 93% (13/14) were able to feed orally. Safety for Evrysdi in the FIREFISH study was consistent with its previously reported safety profile and no new safety signals were identified. The most common adverse events (n=21) included fever (pyrexia; 71%), upper respiratory tract infection (52%), cough (33%), vomiting (33%), diarrhea (29%) and respiratory tract infection (29%). The most serious adverse event that occurred in 24% of infants was pneumonia.   “We are highly encouraged by the results we are seeing in the second year of treatment with Evrysdi,” said Levi Garraway, M.D., Ph. D., Roche’s Chief Medical Officer and Head of Global Product Development. “These results build on the efficacy and safety demonstrated by Evrysdi in pivotal trials, and we look forward to continued assessments of both survival and motor function during long-term follow up for this first-of-its-kind treatment.”  At the time of the analysis, the youngest infant was 28.4 months and the oldest was 45.1 months of age. The median age at enrollment was 6.3 months. Of the 17 infants treated with the therapeutic dose, two experienced fatal complications of their disease at 8 and 13 months of treatment and one infant was withdrawn from the study and sadly died 3.5 months later. None of these were attributed by the investigator as related to Evrysdi.   The data were presented at the virtual 25th International Annual Congress of the World Muscle Society.   Evrysdi is being studied in more than 450 people as part of a broad and robust clinical trial programme in SMA, with patients ranging from birth to 60 years old, and includes pre-symptomatic patients and those previously treated with other SMA-targeting therapies. Evrysdi is designed to treat SMA by increasing and sustaining the production of the survival of motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.  *Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders  About Evrysdi™ (risdiplam)  Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.   The FDA approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. Risdiplam was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. At this time, Evrysdi has been filed in 16 international markets: Australia, Brazil, Chile, India, Indonesia, Israel, Kuwait, Macedonia, Malaysia, Russia, Singapore, South Korea, Taiwan, Thailand, Ukraine and the United Arab Emirates. In addition, four health authorities worldwide are currently reviewing the application: Canada, China, EU and Switzerland.  Risdiplam is currently being evaluated in four multicentre trials in people with SMA: FIREFISH (NCT02913482) – an open-label, two-part pivotal clinical trial in infants with Type 1 SMA. Part 1 was a dose-escalation study in 21 infants with the primary objective of assessing the safety profile of risdiplam in infants and determining the dose for Part 2. Part 2 is a pivotal, single-arm study of risdiplam in 41 infants with Type 1 SMA treated for 2 years, followed by an open-label extension. Enrolment for Part 2 was completed in November 2018. The primary objective of Part 2 was to assess efficacy as measured by the proportion of infants sitting without support after 12 months of treatment, as assessed in the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development – Third Edition (BSID-III) (defined as sitting without support for 5 seconds). The study met its primary endpoint.

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)

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Roche Deep Pipeline Continues To Support Long-Term Value Creation

Roche (RHHBY) buys Inflazome for ???euro 380 million and gains access to pipeline of small molecule NLRP3 inhibitors.

Roche Buys NLRP3 Inflammasome Inhibitors Developer Inflazome

The deal will provide the pharma giant with a unique new platform for tackling autoimmune diseases.

Roche Spends $451 Million to Acquire Inflazome's NLRP3 Program

Roche's (RHHBY) combination of immuno-oncology drug, Tecentriq, and Avastin gets positive CHMP opinion for the treatment of advanced or unresectable HCC.

Roche's Tecentriq + Avastin Gets Positive CHMP Opinion for HCC

DUBLIN & CAMBRIDGE, England--(BUSINESS WIRE)-- #NLRP3--Inflazome announced today that it has closed a share purchase agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) in which Inflazome’s shareholders received an upfront payment of €380 million, and are eligible to receive additional contingent payments to be made based on the achievement of certain predetermined milestones. Inflazome was founded in 2016 by leading medical researchers Prof Matt Cooper (University of Queensland, Australia) and Prof Luke

Inflazome Announces Acquisition by Roche

Basel, 19 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.  “While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are proud of our work to address challenges and advance scientific understanding of cancer immunotherapy in the context of distinct chemotherapy regimens and in various TNBC treatment settings. Although the IMpassion131 study did not reach its endpoint, we are pleased to bring new treatment options for some TNBC patients, and remain committed to improving the lives of all women with early and advanced stages of this disease.”  Results from the Phase III IMpassion031 study, evaluating Tecentriq in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy (including nab-paclitaxel), demonstrated a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early TNBC, regardless of PD-L1 expression. pCR was observed in 57.6% (95% CI: 49.7–65.2) of patients treated with Tecentriq in combination with chemotherapy, an increase of 16.5% from 41.1% (95% CI: 33.6–48.9) in patients treated with placebo plus chemotherapy (one-sided p=0.0044, significance boundary = 0.0184) in the intention-to-treat (ITT) population. The safety profile was consistent with the established profile of the individual drugs and no new safety concerns were identified.  The IMpassion031 study is the second positive Phase III study from Roche demonstrating the benefit of Tecentriq in TNBC, and the first Tecentriq study to demonstrate benefit in early TNBC. Tecentriq in combination with nab-paclitaxel is currently approved in more than 70 countries worldwide, including the US and across Europe, for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumours express PD-L1 (IC≥1%).  The final overall survival (OS) analysis of the Phase III IMpassion130 study, evaluating Tecentriq in combination with nab-paclitaxel, compared with placebo plus nab-paclitaxel, as a first-line treatment for patients with metastatic TNBC, was consistent with the first and second interim analyses. There was no significant difference in OS between the treatment groups in the ITT population. Clinically meaningful improvements in OS were seen with Tecentriq plus nab-paclitaxel in PD-L1-positive patients. The magnitude of OS improvements with Tecentriq in PD-L1-positive patients remained clinically meaningful, with an increase of 7.5 months in median OS with Tecentriq plus nab-paclitaxel, compared with placebo plus nab-paclitaxel (hazard ratio [HR]=0.67; 95% CI: 0.53–0.86). However, this result could not be formally tested due to the prespecified statistical testing hierarchy. The cumulative safety of the Tecentriq plus nab-paclitaxel combination remains consistent with the previously reported safety data for this study and the known risks of individual study drugs. No new safety concerns were identified with longer follow-up.  Finally, results from the Phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel, compared with placebo plus paclitaxel, as a first-line treatment for patients with metastatic TNBC, did not show significant improvement for progression-free survival in the PD-L1-positive population (HR=0.82; 95% CI: 0.60–1.12). The OS data showed a negative trend; however, the study was not powered for the secondary endpoint of OS, and OS data were immature at time of analysis (initial HR=1.55 [95% CI: 0.86-2.80] in the PD-L1 positive population, based on 21% of patients with an event; updated HR=1.12 [95% CI: 0.76-1.65]), updated analysis based on 41% of patients with an event). The safety profile of Tecentriq plus paclitaxel was consistent with the established safety profile of the individual study drugs and no new safety concerns were identified.  Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across several types of 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 IMpassion031 study  The IMpassion031 study is a Phase III, multicentre, randomised, double-blind study evaluating the efficacy and safety of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy, in people with previously untreated, early TNBC. The study enrolled 333 people who were randomised in a 1:1 ratio to receive Tecentriq or placebo plus chemotherapy in the neoadjuvant (before surgery) setting. Treatment with Tecentriq continued adjuvantly (after surgery) for those in the Tecentriq arm of the study. The primary endpoint is pCR using the American Joint Committee on Cancer (AJCC) staging system in the ITT population and in the PD-L1-positive population. Secondary endpoints include OS, event-free survival, disease-free survival and quality of life measures.

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development program in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. “While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficul

Genentech Presents New Data From Multiple Phase III Studies of Tecentriq in Triple-Negative Breast Cancer at ESMO Virtual Congress 2020

Roche Holding AG (SWX: RO) remained in headlines on Friday as the company expressed confidence that according to a study, its drug Actemra is effective in minimising the severity of COVID-19 in hospitalised patients. The U.S. FDA also approved Roche’s CINtec PLUS Cytology test for expanded use earlier this week to aid clinicians in preventing cervical cancer.

Roche says its Actemra drug reduces the severity of COVID-19 in hospitalised patients

Roche stock is rallying Friday on news that Actemra, an anti-inflammatory drug from the Swiss company, may help coronavirus patients.
The post Roche Stock Rallies on Promising Coronavirus Drug Results appeared first on InvestorPlace.

Roche Stock Rallies on Promising Coronavirus Drug Results

Roche's (RHHBY) phase III study, EMPACTA, evaluating Actemra in patients with COVID-19-associated pneumonia, meets primary endpoint.

Roche's Actemra Meets Goal in Phase III Coronavirus Study

Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Based on this recommendation, a final decision regarding approval of Tecentriq in combination with Avastin in this disease setting, along with the full details of the approved indication, is expected from the European Commission in the near future.  “Today’s recommendation by the CHMP is a major step towards bringing Tecentriq in combination with Avastin to people in Europe who suffer from advanced or unresectable hepatocellular carcinoma,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “This represents an important milestone in a deadly malignancy and is part of our long-term commitment to improve the lives of people with various types and stages of liver disease.”  “After more than a decade of therapeutic stagnation, the results of the IMbrave150 study are likely to change the way we treat patients with liver cancer who are diagnosed at or reach the advanced stage,” said Professor Bruno Sangro, Director of the Liver Unit and Coordinator of the HPB Oncology Area at Clinica Universidad de Navarra in Pamplona, Spain. “The data from the study showed that the combination of Tecentriq and Avastin results in longer survival with better quality of life than any current choice of tyrosine kinase inhibitor and, for a large subset of patients, is able to induce deep, durable and sometimes complete tumour remissions.”   The recommendation from the CHMP is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death (overall survival [OS]) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42–0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival [PFS]) by 41% (HR=0.59; 95% CI: 0.47–0.76; p

Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer

Shares of Roche Holding AG ROG, +2.06% gained 1.9% in premarket trading on Friday after the drug maker said hospitalized COVID-19 patients taking rheumatoid arthritis drug Actemra were less likely to need mechanical ventilation than those receiving placebo.

Shares of Roche gain as it says arthritis drug can lessen need for ventilators in COVID-19 patients

Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).   The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response.1 Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. The majority of current candidate vaccines aim to induce an antibody response against the spike protein.  “As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, quantitative measurement of antibodies will be crucial in the evaluation of any potential vaccine. The new quantitative Elecsys antibody test can play a pivotal role in vaccine clinical trials as well as helping clinicians assess patients immune response.This will be instrumental in protecting people most vulnerable to the virus, as well as in overcoming COVID-19 for society in general.” said Thomas Schinecker, CEO Roche Diagnostics. "This new test, the twelfth in the Roche SARS-CoV-2 testing portfolio, is another essential addition to support healthcare systems and patients as we jointly fight COVID-19.”  Before a vaccine is administered it is important to know the starting level of antibodies a person has, in order to evaluate any change in antibody levels that the vaccine induces, especially the development of antibodies directed against the SARS-CoV-2 spike protein. These antibodies have been shown to have potent antiviral activity and correlate to potential immunity.2 Measuring antibody levels could also be vital in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.1   Alongside its importance to vaccine design and efficacy evaluations, the Elecsys Anti-SARS-CoV-2 S serology test can be used to determine antibody levels in plasmapheresis donations. Performing a combination of the Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 tests can also help to more effectively define what percentage of a given population has developed antibodies (seroprevalence) against SARS-COV-2, especially in low to moderate seroprevalence settings.3 Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions.  The test is the latest addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology and digital solutions which help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.  About SARS-CoV-2  Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been identified in humans.  Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.4   About potential SARS-COV-2 vaccines  As of 3 September  2020, 47 candidate vaccines are in clinical evaluation and 3 vaccines have been approved for early or limited use, while at least 91 preclinical vaccines are under active investigation.1,5 All candidate vaccines in Phase III or approved for limited / early use aim to induce an antibody response against the SARS-CoV-2 spike protein. Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralising antibodies, in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognize and fight an exposure to SARS-CoV-2, in a controlled way, without being exposed to the actual virus.1    About Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 serology tests The Elecsys® Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test can measure the quantity of antibodies to the spike protein of the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This can also be used to determine antibody levels in plasmapheresis donations. Plasmapheresis is a procedure which separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor.  It is assumed that plasma from a donor who has already had SARS-CoV-2 will have direct antiviral properties for the donor recipient.6 This is being explored as an adjunctive treatment for the management of COVID-19.6 The test has both a high clinical specificity of 99.98% (N=5991) and sensitivity of 98.8% (N=1423), 14 days or later after diagnosis with PCR. Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity.  Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.3   *The Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of antibodies (including IgG) to SARS-CoV-2. The test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This test can also help in the determination of seroprevalence (i.e. the frequency of individuals with antibody to the virus), in a given population, as well as a complement test to Nucleic Acid Amplification Tests (NAAT) for the diagnosis of SARS-CoV-2 infection. The test runs on Roche’s cobas e analyzers which are widely available around the world.3   About Roche response to COVID-19 section  The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:

Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines

Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra®/RoActemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra/RoActemra.  “The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with COVID-19 associated pneumonia, an important outcome in this serious disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We plan to share this important data with the US Food and Drug Administration (FDA) and other health authorities around the world.”  The study is the first global, phase III COVID-19 clinical trial to primarily enrol patient populations that are often underrepresented in clinical studies and have been disproportionately affected by the COVID-19 pandemic. Approximately 85% of the 389 patients were from minority racial and ethnic groups. The majority of patients were Hispanic, with significant representation of Native American and Black populations. The trial was conducted in the United States, South Africa, Kenya, Brazil, Mexico and Peru.  “We have been striving to improve inclusion and diversity in our trials,” said Jamie Freedman, M.D., Ph.D., Head of U.S. Medical Affairs. “During the COVID-19 pandemic, we saw how high the stakes were for many communities of colour and made diversity the centerpiece of this trial.”  The EMPACTA trial builds on Roche’s work in  Advancing Inclusive Research , a cross-organisational US initiative to help address barriers in clinical research for underrepresented racial and ethnic groups.

Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia

Basel, 17 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that results from a number of studies across its broad oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which will be held 19-21 September, 2020. Results include data from three phase III studies across the Tecentriq ®  (atezolizumab) triple-negative breast cancer (TNBC) programme. Central nervous system (CNS) efficacy data from integrated analyses of the pivotal phase II Rozlytrek ®  STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented in addition to results from the registrational phase I/II ARROW trial, investigating GavretoTM for the treatment of people with advanced, RET-mutant medullary thyroid cancer (MTC). Data from the phase III IPATential150 study in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumours had PTEN loss will also be shared.   Roche will also be hosting a live roundtable discussion that will focus on COVID-19 and the impact it may have on the outcomes for cancer patients. The discussion will focus on potential solutions and what lessons have been learned from the pandemic so far. Two additional sessions will look into pandemic-related lessons learned with regards to the integration of technology into patient management and the impact of digital tumour board solutions on multidisciplinary meetings.   “Our commitment to transforming the outcomes of people living with cancer remains steadfast, so we are proud to be presenting data at this year’s congress that advances the scientific understanding of multiple complex diseases,” said Levi Garraway, M.D., Ph.D. Roche's Chief Medical Officer and Head of Global Product Development. “As a direct result of the pandemic, many countries are reporting a disruption to cancer care which could potentially result in the premature deaths of tens of thousands of cancer patients. Therefore, we must work together to ensure that we do not swap one health crisis for another: cancer patients simply cannot afford to wait.”  The pandemic has accelerated the need for collaboration among all stakeholders involved in cancer care to address key gaps and challenges that require urgent action by governments and policy makers. To discuss these issues and call for a course correction for all cancer care services, a live virtual panel discussion and Q&A featuring leading experts from medical societies, academia and the patient group community, will take place on Tuesday 22 September 2020, 15:00 CEST. Join this event on Roche’s  LinkedIn page here . Two additional sessions will look into related topics in the context of treatment decision making. In the first session, insights will be shared by Italian experts on how the pandemic has affected cancer care and how digital solutions helped them to continue shared decision making remotely.  Sign up here  for the session on Saturday, 19 September, 16:00-16:30 CEST. The second talk illustrates challenges faced by multidisciplinary teams when convening tumour boards and their real-world experience with a digital tumour board solution in the pandemic.  Sign up here  for the session on Saturday, 19 September, 16:30-17:00 CEST.  Roche highlights featured at ESMO Virtual Congress 2020   Breast cancer portfolio  At ESMO, results from recent studies across the Tecentriq TNBC programme (both early and metastatic TNBC) will be presented, including final OS analysis from the phase III IMpassion130 study (Tecentriq in combination with nab-paclitaxel [Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound)] in mTNBC)], results from the IMpassion031 study (Tecentriq in combination with nab-paclitaxel [Abraxane, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide] in the early TNBC setting), and results from the phase III IMpassion131 study (Tecentriq in combination with paclitaxel in mTNBC).  In HER2-positive breast cancer, results will highlight our focus on improving patients’ experience of cancer treatment, looking beyond efficacy outcomes and focusing on more flexible treatment solutions. Data from the phase II PHranceSCa study show the majority of patients prefer treatment with Phesgo™, a subcutaneous (SC) fixed-dose combination of Perjeta ®  (pertuzumab) and Herceptin ®  (trastuzumab), compared to standard intravenous formulations. Phesgo was recently approved by the U.S. Food and Drug Administration, about four months earlier than anticipated, for the treatment of early and metastatic HER2-positive breast cancer. Based on the decision of the treating physician and the preference of the patient, it can be administered by a healthcare professional in a treatment centre or in a patient’s home.   Data will also be presented for two of our investigational hormone receptor (HR)-positive breast cancer treatments, both of which target the PI3K/AKT signalling pathway, a key driver of cancer cell growth and proliferation. GDC-0077 is our next generation investigational PI3Kα-selective inhibitor and mutant PI3Kα degrader designed to inhibit the growth of tumour cells that have mutations in the PIK3CA gene. We will present PI3K pathway biomarker and clinical response data from a phase I/Ib study of GDC-0077 and announce the design of an ongoing phase III study evaluating GDC-0077 in HR-positive, HER2-negative advanced breast cancer. In addition, results will be shared from phase III IPATunity130 cohort B assessing ipatasertib in combination with paclitaxel in patients with PIK3CA/AKT1/PTEN-altered HR-positive advanced breast cancer.  Tecentriq in lung cancer Results from an exploratory analysis of characterisation of long-term survivors (LTS), defined in the study as people who survived for longer than 18 months following randomisation, in the IMpower133 trial will be presented in a mini-oral session. The study previously showed that Tecentriq in combination with chemotherapy helped people with extensive-stage small cell lung cancer (ES-SCLC) live significantly longer compared with chemotherapy alone. SCLC is distinguished from other lung cancer subtypes due to its aggressive nature, rapid growth and early development of metastatic disease.  In addition, four-year survival data from the phase II POPLAR and phase III OAK studies, investigating Tecentriq vs docetaxel (chemotherapy) in patients with advanced pre-treated non-small cell lung cancer (NSCLC) will be presented.  Tumour-agnostic data  Two sets of CNS efficacy data from integrated analyses of the pivotal phase II STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials will be presented, including a poster presentation evaluating the efficacy of Rozlytrek in patients with NTRK or ROS1 fusion-positive NSCLC, who have CNS metastases at baseline; and an oral presentation evaluating the intracranial efficacy of Rozlytrek in patients with NTRK fusion-positive solid tumours with baseline CNS metastasis. In addition, an updated integrated analysis of the phase II STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials, investigating the efficacy and safety of Rozlytrek in locally advanced/metastatic ROS1-positive NSCLC, which evaluated a larger dataset with longer follow-up (15.8 months) will be presented.  Gavreto in RET-mutant medullary thyroid cancer At ESMO, Blueprint Medicines will present results from the registrational phase I/II ARROW trial, investigating Gavreto for the treatment of people with advanced, RET-mutant medullary thyroid cancer. Gavreto is being jointly commercialised by Genentech, a wholly owned member of the Roche Group, and Blueprint Medicines in the U.S. and will be commercialised by Roche outside of the U.S., excluding Greater China (encompasses Mainland China, Hong Kong, Macau and Taiwan). Blueprint Medicines and Gavreto are trademarks of Blueprint Medicines Corporation.   Subcutaneous formulation of atezolizumab (Tecentriq)  First data from the phase Ib dose-finding study (Part 1 of IMscin001) of subcutaneous atezolizumab (Tecentriq) in patients with locally advanced or metastatic NSCLC will also be presented. The subcutaneous formulation of atezolizumab (Tecentriq) is being developed to potentially allow faster administration via an injection under the skin, compared to the original intravenous (IV) formulation, thereby significantly reducing a patient's time spent receiving treatment. Based on previous studies of other monoclonal antibodies, subcutaneous is generally a preferred route of administration by patients, physicians, healthcare providers and can be associated with hospital time- and cost-savings.  PHC symposium In light of ESMO’s 2020 motto, “bringing innovation to cancer patients”, Roche is hosting a symposium that explores what it takes to put personalised healthcare at the heart of clinical practice. Leading experts will discuss recent innovations in the field of personalised healthcare within oncology like the use of blood based molecular testing. Furthermore, the panelists will also discuss how to accelerate the adoption personalised oncology in healthcare systems. The symposium is tailored for healthcare professionals and includes a virtual live Q&A with the faculty on Friday, 18 September, 17:00-17:30 CEST.  Follow Roche on Twitter via @Roche and keep up to date with ESMO news and updates by using the hashtag #ESMO20.  Overview of key presentations featuring Roche medicines at ESMO 2020

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec® PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtec PLUS Cytology to triage positive results from the cobas® HPV Test run on the fully integrated, automated and high-throughput cobas® 6800/8800 Systems.  High-risk HPV is the principal cause of cervical cancer, which is one of the most common cancers in women globally. The World Health Organization has set goals for countries to take action to eliminate cervical cancer by 2030.  “With our portfolio of cervical cancer tests and automated testing platforms, we are committed to providing clinicians and laboratories with the best tools possible to protect women’s health,” said Thomas Schinecker, CEO Roche Diagnostics. “This expanded indication for CINtec PLUS Cytology gives laboratories the flexibility to triage cobas HPV test results on their choice of cobas® Systems and deliver accuracy needed to reliably detect HPV infections that are starting to cause cellular changes that could lead to cancer. The biomarker information helps to clarify a woman’s risk of disease, reduce the potential for over- or under-treatment, and is a major step forward in individualising a woman’s care.”  HPV DNA screening identifies women at risk for cervical cancer by detecting the presence of high-risk HPV DNA in cervical samples. While most HPV infections resolve on their own, some women who test positive for the virus, or whose co-testing results are discrepant (HPV positive/Pap cytology negative), may have or may develop pre-cancerous cervical lesions. These lesions could progress to cervical cancer if left untreated.   About human papillomavirus and cervical cancer  Persistent infection with high-risk human papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide.1 Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment; expanding access helps reach more women in underserved communities where the disease burden is highest.2,3 It can take 10 to 15 years or longer for cervical cancer to develop, so knowing a woman’s individual risk and finding disease early, before cancer develops, is an important prevention strategy.  About 13,800 new cases of invasive cervical cancer will be diagnosed in the U.S. in 2020, according to the American Cancer Society, and about 4,290 women will die from the disease this year. Globally, the World Health Organization estimates there are more than 570,000 new cases of cervical cancer annually, and 311,000 deaths.4 Learn more about the  Roche Cervical Cancer Global Access Program .  About CINtec PLUS Cytology  The CINtec PLUS Cytology test detects the simultaneous presence within a single cell of the two biomarkers -- p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease. The ability of CINtec PLUS Cytology to distinguish those women who are at higher risk for cervical disease provides labs, physicians and women, in conjunction with the clinician’s assessment of patient screening history, other risk factors, and professional guidelines information, to guide patient management. Women with negative dual stain results are at significantly lower risk for cervical disease and their bodies can be given more time to clear HPV infection on their own. This could reduce the number and frequency of follow-up visits, saving some patients worry and time.  The CINtec PLUS Cytology test, which runs on the BenchMark ULTRA IHC/ISH system, is performed using the same sample that is used for HPV or liquid-based Pap cytology tests. This eliminates the need for additional or repeat sample collection or time spent waiting to find out if an infection is clearing.  For U.S. approval, the FDA considered data from the Roche-sponsored registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled approximately 35,000 women in the U.S. to clinically validate CINtec PLUS Cytology as a triage test in various screening scenarios. This latest expanded use approval gives laboratories access to the complete Roche Cervical Cancer Portfolio offering in the U.S., which includes the cobas HPV Test, CINtec PLUS Cytology and CINtec Histology. Depending on their workflow needs, labs now have the choice to fully automate their highest volume assays and utilise biomarker technology to offer more advanced, next-generation cytology solutions. Publication of the full IMPACT study findings is pending.  Prior to FDA approvals for its use for the triage of women who are HPV positive using the cobas HPV Test on the cobas® 4800 or cobas 6800/8800 Systems, the CINtec PLUS Cytology CE-IVD test had been used as a triage test for HPV-positive results and mildly abnormal Pap cytology results in Europe, Asia, South America, Canada and Australia.  About the Roche Cervical Cancer Portfolio  The Roche Cervical Cancer Portfolio enables healthcare professionals to screen, triage and diagnose women, based on the confidence and clarity of results across a continuum of patient care. The unique combination of molecular, cellular cytology and tissue-based tests provides healthcare professionals powerful information to make patient care decisions and minimise unnecessary treatment. Along with cobas HPV for screening, and CINtec PLUS Cytology, CINtec Histology is used as an aid to confirm the presence of cervical disease in women who have had a tissue biopsy. CINtec Histology is the only FDA-cleared test that uses the p16 biomarker for a more conclusive diagnosis to provide distinctive visual confirmation of precancerous cervical lesions that may be missed by hematoxylin and eosin (H&E) interpretation alone. Like CINtec PLUS Cytology, CINtec Histology is also fully automated on the BenchMark IHC/ISH instruments.  About the BenchMark ULTRA IHC/ISH system  The BenchMark ULTRA system is a fully automated immunohistochemistry and in situ hybridization slide staining system, offering multiple features designed to provide diagnostic confidence to histopathology laboratories worldwide. With 30 independent slide drawers, the system gives histotechnologists continuous random access and supports single-piece workflow, which numerous studies have shown improves laboratory operational efficiency.  About cobas Systems  cobas HPV tests run on cobas Systems and are indicated for use for routine cervical cancer screening to assess the risk in women for cervical precancer and cancer as per professional medical guidelines, including primary screening, triage of ASC-US cytology and co-testing (or adjunctive screen) with cytology. These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship.  They are also part of the Molecular Work Area—a fully integrated laboratory workflow solution that empowers labs to significantly elevate their levels of efficiency, flexibility and scalability.  When every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success … now, more than ever. Learn more now:  www.cobas68008800.com .  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 .  BENCHMARK, CINTEC and COBAS are trademarks of Roche. All other trademarks are the property of their respective owners.  References [1] Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189:12-19. [2] Schiffman M, Doorbar J, Wentzensen N, et al. Carcinogenic human papillomavirus infection. Nat Rev Dis Primers. 2016; 2:16086. [3] Bosch FX, Broker TR, Forman D, et al. Comprehensive control of human papillomavirus infections and related diseases. Vaccine. 2013;31 Suppl 8:I1-31. [4] World Health Organization,  www.who.int/health-topics/cervical-cancer#tab=tab_2     Roche Group Media Relations Phone: +41 61 688 8888 / e-mail:  media.relations@roche.com

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

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Basel, 11 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data that show OCREVUS® (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT). Subgroup analysis from the two-year open-label Phase IIIb CASTING study also demonstrates that patients benefit across a wide range of disease related and demographic subgroups, regardless of prior treatment background. Findings will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).  “For a wide range of people with MS who experienced a suboptimal response to prior treatment, we continue to see evidence that OCREVUS provides significant benefit in slowing disease progression,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “New real-world OCREVUS data show high persistence and adherence to the only B-cell therapy with a twice-yearly dosing schedule, which we know can be very important to both people with MS and their physicians.”  Phase IIIb open-label CASTING study  Approximately 75% of RRMS patients (492/658) had no evidence of disease activity (NEDA; brain lesions, relapses and worsening of disability) two years after switching to twice-yearly OCREVUS treatment (with prespecified MRI re-baselining at 8 weeks) in the primary analysis of the CASTING study. Patients enrolled in the study had prior suboptimal response to at least six months of treatment with up to two DMTs. The analysis also showed the proportion of patients achieving NEDA remained consistently high across all measured patient subgroups, including baseline MRI activity, relapse activity, disability level, age and the number of prior DMTs. Further, 78% of patients treated with only one prior DMT compared with 70% of patients treated with two prior DMTs achieved NEDA.  Additionally, patients treated with OCREVUS experienced an improvement in the majority of symptoms measured by SymptoMScreen after two years. SymptoMScreen is a patient-reported outcome tool to assess symptom severity across twelve domains. The most pronounced significant improvements (p

New data further reinforce Roche’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis

Basel, 10 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. These data are being presented at MSVirtual2020, the 8th joint ACTRIMS-ECTRIMS meeting, in addition to longer-term efficacy data supporting the continued effect of ENSPRYNG on reducing the risk of NMOSD relapse, as well as its favourable benefit:risk profile.  “The data for ENSPRYNG at MSVirtual2020 are promising and suggest it significantly reduces relapse severity and frequency, which are important goals of the treatment for people with NMOSD,” said Professor Anthony Traboulsee, M.D., Neurologist and Professor, University of British Columbia, and Research Chair of the MS Society of Canada. “ENSPRYNG, the first approved treatment for NMOSD that can be taken at home, offers favourable efficacy and safety, which are important for improved long-term outcomes.’’  In a post-hoc analysis of the ENSPRYNG-treated group, the risk of severe relapse was reduced by 79% compared to placebo (5 of 27 [19%] vs. 12 of 34 [35%]), for patients across the double-blind periods of the SAkura studies. Preventing relapses, the most severe of which cause cumulative, irreversible, neurological damage and disability, is the primary goal for NMOSD disease management. The patients treated with ENSPRYNG were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, p=0.015). A relapse was categorised as severe if it resulted in a change of ≥2 points on the Expanded Disability Status Scale.  In a separate pooled analysis, ENSPRYNG reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; p=0.002) compared to those originally in the placebo group. This effect was more pronounced in aquaporin-4 antibody (AQP4-IgG) seropositive patients, who tend to experience a more severe disease course, with 66% reduction in risk of relapse (HR, 0.34; 95% CI, 0.19–0.62; P

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

Roche (RHHBY) expands its MS portfolio by adding pipeline candidate, fenebrutinib. The company also initiates MS studies on fenebrutinib and Ocrevus.

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