Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III COVACTA study of Actemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra. The COVACTA study did not identify any new safety signals for Actemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.

“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigor. We will keep working to help combat the COVID-19 pandemic.”

The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.

COVACTA evaluated the safety and efficacy of intravenous Actemra added to standard-of-care treatment and compared to treatment with placebo plus standard of care. The primary endpoint of clinical status in hospitalized patients with severe COVID-19 pneumonia was measured by a 7-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements. The COVACTA trial is the first global, randomized, double-blind, placebo-controlled Phase III study to investigate Actemra in adult patients hospitalized with severe COVID-19 associated pneumonia, with study locations in the United States, Canada and Europe.

Summary of Key COVACTA Clinical and Safety Findings

• Primary endpoint not met: The difference in clinical status between Actemra and placebo in patients assessed using a 7-category ordinal scale at week four was not statistically significant (p=0.36; odds ratio [95% CI] = 1.19 [0.81,1.76], a statistically significant odds ratio greater than 1 would have favored Actemra).
• There was no difference between Actemra and placebo in the percentage of patients that died by week four (Actemra = 19.7% and placebo = 19.4% with a difference [95% CI] of 0.3% [-7.6%,8.2%], p=0.9410).
• Time to hospital discharge or ‘ready to discharge’ was shorter in patients treated with Actemra than those treated with placebo. The median time to discharge or ‘ready to discharge’ for Actemra was 20 days and for placebo was 28 days (median time [95% CI]: Actemra = 20.0 [17.0,27.0]; placebo = 28.0 [20.0,NE], p=0.0370). However, the difference cannot be considered statistically significant as the primary endpoint was not met.
• The difference in ventilator-free days between Actemra and placebo was not statistically significant (median of 22 days for Actemra and 16.5 days with placebo, difference in medians [95% CI] = 5.5 [-2.8,13.0], p=0.3202).
• At week four, rates of infections were 38.3% and 40.6% in the Actemra and placebo arms, respectively, and the rates of serious infections were 21.0% and 25.9% in the Actemra and placebo arms, respectively. The most common adverse events in patients who received Actemra were COVID-19 pneumonia (10.5%), hypertension (6.4%), pneumonia, acute kidney injury and diarrhea (5.8% each). The COVACTA study did not identify any new safety signals for Actemra.

In addition to COVACTA, Genentech has initiated several studies to further investigate Actemra as a potential treatment for patients with COVID-19 associated pneumonia, including two Phase III clinical trials, REMDACTA and EMPACTA, as well as the Phase II MARIPOSA trial. There are a number of independent trials of Actemra in this setting. Actemra has not previously been studied in, nor approved for, COVID-19 associated pneumonia.

For more information on how Genentech is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.

About the COVACTA Trial

COVACTA is a global, randomized, double-blind, placebo-controlled Phase III study (COVACTA, NCT04320615) evaluating the safety and efficacy of intravenous Actemra added to standard of care in adult patients hospitalized with severe COVID-19 associated pneumonia compared to placebo plus standard of care. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomization.

About Actemra

Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA) and for patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.

Actemra is intended for use under the guidance of a healthcare practitioner.

Important Safety Information

Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.

Actemra can cause other serious side effects. These include:

• Tears of the stomach or intestines
• Liver problems (hepatotoxicity)
• Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
• An increased risk of certain cancers by changing the way a patient’s immune system works
• Hepatitis B infection
• Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection. If a patient has had hives, a rash, or experienced flushing after injecting, the patient should tell their doctor or nurse before their next injection
• Nervous system problems

Patients should not receive Actemra if they are allergic to Actemra or if they have had a bad reaction to Actemra previously.

Most common side effects in patients treated with Actemra:

Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:

• Upper respiratory tract infections (like common cold and sinus infections)
• Headache
• Increased blood pressure (also called hypertension)
• Injection site reactions

Actemra & pregnancy:

Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).

Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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