Genentech’s Phase III EMPACTA Study Showed Actemra Reduced the Likelihood of Needing Mechanical Ventilation in Hospitalized Patients With COVID-19 Associated Pneumonia

Genentech, a member of the Roche Group (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® (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 arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra.

“The EMPACTA trial demonstrated that Actemra can reduce the need for mechanical ventilation in patients with COVID-19 pneumonia, an important outcome in this serious disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We plan to share this important data with the FDA and other health authorities around the world.”

The study is the first global, Phase III COVID-19 clinical trial to primarily enroll 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 or African American 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 color and made diversity the centerpiece of this trial.”

The EMPACTA trial builds on Genentech’s work in Advancing Inclusive Research, a cross-organizational U.S. initiative to help address barriers in clinical research for underrepresented racial and ethnic groups.

Summary of Key EMPACTA Clinical and Safety Findings

• Primary endpoint was met: patients with COVID-19 associated pneumonia who received Actemra 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 arm versus 19.3% in the placebo arm.
• Key secondary endpoints
  • The difference in time to hospital discharge or “ready for discharge” to day 28 was not significant (median (days): Actemra = 6; placebo (PBO) = 7.5; log-rank p-value = 0.2456; HR [95% CI] = 1.16 [0.90, 1.48]).
  • The difference in time to improvement in ordinal clinical status to day 28 was not significant (median (days): Actemra = 6; PBO = 7; log-rank p-value = 0.2597; HR [95% CI] = 1.15 [0.90, 1.47]).
  • Time to clinical failure to day 28 was longer in the Actemra arm compared to the placebo arm (median (days): Actemra = not-estimable (NE); PBO = NE; log-rank p = 0.0217; HR [95% CI] = 0.55 [0.33, 0.92]). However, the difference cannot be considered statistically significant as other key secondary endpoints were not met.
  • There was no statistical difference in mortality between patients who received Actemra or placebo by day 28 (Actemra = 10.4%; PBO = 8.6%, p-value = 0.5146, Difference [95% CI]: 2.0% [-5.2%, 7.8%]).
• At day 28, incidence of infections was 10% and 11% in the Actemra and placebo arms, respectively, and the incidence of serious infections was 5.0% and 6.3% in the Actemra and placebo arms, respectively. The most common adverse events in patients who received Actemra were constipation (5.6%), anxiety (5.2%), and headache (3.2%). The EMPACTA study did not identify any new safety signals for Actemra.

Results from the EMPACTA trial will be submitted for publication in a peer-reviewed journal.

Actemra is currently being investigated as a potential treatment for COVID-19 associated pneumonia, including in combination with an anti-viral in the Phase III REMDACTA clinical trial. Results from the Phase III COVACTA trial in patients with severe COVID-19 associated pneumonia were released in July. In addition, there are a number of independent trials of Actemra in this setting. Actemra has not been approved by any health authority 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 EMPACTA Trial

EMPACTA (Evaluating Minority Patients with Actemra) is a Phase III, randomized, double-blind, placebo-controlled multicenter study (EMPACTA, NCT04372186) to evaluate the efficacy and safety of Actemra in the treatment of hospitalized COVID-19 associated pneumonia among patients that are often underrepresented in clinical trials.

The trial enrolled hospitalized patients older than 18 years with confirmed SARS-CoV-2 (COVID-19) infection with SpO2 <94% while on ambient air who did not require noninvasive or invasive mechanical ventilation. The primary endpoint is the cumulative proportion of participants dying or requiring mechanical ventilation by Day 28. Secondary objectives include: time to clinical failure, defined as the time to death, mechanical ventilation, ICU admission, or withdrawal (whichever occurs first); mortality rate by Day 28; and time to hospital discharge or “ready for discharge.”

The study enrolled 389 patients in the United States, South Africa, Kenya, Brazil, Mexico and Peru.

About the REMDACTA Trial

REMDACTA is a two-armed global Phase III, randomized, double-blind, multicenter study (REMDACTA, NCT04409262) to evaluate the efficacy and safety of Actemra plus remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 associated pneumonia receiving standard of care. The REMDACTA trial is being conducted in collaboration with Gilead Sciences, Inc. The primary endpoint of the study is clinical status as measured by a 7-Category Ordinal Scale by Day 28. Key secondary endpoints include mortality, mechanical ventilation, and intensive care 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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