Genentech’s Phase III EMPACTA Study Showed Actemra Reduced the Likelihood of Needing Mechanical Ventilation in Hospitalized Patients With COVID-19 Associated Pneumonia - Seite 2

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.