Genentech Initiates Phase III Clinical Trial of Actemra Plus Remdesivir in Hospitalized Patients With Severe COVID-19 Pneumonia

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the initiation of a global Phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra® (tocilizumab) plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.

“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease. We're pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”

The study is expected to begin enrolling in June with a target of approximately 450 patients globally, including the United States, Canada and Europe.

In addition to REMDACTA, Genentech is close to completing enrollment of the global randomized, double-blind, placebo-controlled Phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra plus standard of care (SOC), versus placebo plus SOC in hospitalized adult patients with severe COVID-19 pneumonia. The first patient was randomized on April 3. In total, approximately 450 patients will be enrolled in COVACTA. This increase from the original target of 330 patients will allow for even more robust data, while minimally extending the recruitment period. Actemra is not currently approved for this use by the U.S. Food and Drug Administration (FDA). Genentech is committed to sharing data from the COVACTA study as soon as possible this summer. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Data from the REMDACTA trial are designed to supplement the COVACTA study.

The COVACTA study is conducted in collaboration with the FDA and the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). Genentech is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, led by the National Institutes of Health (NIH) and the Foundation of the NIH.

Genentech has also initiated a national Phase III double-blind, placebo-controlled randomized trial (EMPACTA, NCT04372186) that will focus on recruiting approximately 375 patients at trial sites known to provide critical care to underserved and minority populations that often do not have access to clinical trials.

Remdesivir has been issued an Emergency Use Authorization by the FDA for the treatment of hospitalized patients with severe COVID-19. Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has not been approved by the FDA for any use. For information about the authorized use of remdesivir and mandatory requirements of the Emergency Use Authorization in the United States, please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization available at www.gilead.com/remdesivir.

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

About the REMDACTA Clinical Trial

REMDACTA is a two-armed global Phase III, randomized, double-blind, multicenter study to evaluate the efficacy and safety of Actemra plus remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia receiving standard of care (SOC). The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care (ICU) variables. Patients will be followed for 60 days post-randomization.

About the COVACTA Clinical Trial

COVACTA is a global, randomized, double-blind, placebo-controlled Phase III study (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra added to standard of care (SOC) in approximately 450 adult patients hospitalized with severe COVID-19 pneumonia compared to placebo plus SOC. The primary endpoint is clinical status assessed using a 7-Category Ordinal Scale at day 28. The ordinal scale ranges from one (discharged from hospital) to seven (death), and covers different hospital locations such as non-intensive care unit (non-ICU) or ICU, and ventilation/treatment requirements, including not requiring supplemental oxygen, or requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support. Key secondary endpoints include mortality, mechanical ventilation, clinical status at day 14, time to clinical improvement, and time to discharge.

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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