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.