Phase 3 EMPACTA Study: Tocilizumab Shows Efficacy in COVID-19 Associated Pneumonia

Treatment with tocilizumab (Actemra; Genentech) reduced the likelihood of needing mechanical ventilation in hospitalized patients with coronavirus disease 2019 (COVID-19 associated pneumonia, according to results from a phase 3 study.

Tocilizumab is a humanized interleukin-6 receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis, with additional indications in giant cell arteritis, active polyarticular juvenile idiopathic arthritis, and active systemic juvenile idiopathic arthritis.

The phase 3 EMPACTA study, the first trial to primarily enroll patient populations underrepresented in clinical studies and disproportionately affected by COVID-19, assessed the efficacy and safety of tocilizumab in the treatment of hospitalized COVID-19 associated pneumonia.

EMPACTA enrolled hospitalized patients aged 18 years and older with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection with SpO2 <94% while on ambient air who did not require noninvasive or invasive mechanical ventilation. Approximately 85% of the 389 patients in the study were Hispanic, with significant representation of Native American and Black populations as well.

According to the results, patients with COVID-19 associated pneumonia who received tocilizumab plus standard of care were 44% less likely to progress to mechanical ventilation or death, compared with patients who received placebo plus standard of care. The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the tocilizumab arm versus 19.3% in the placebo arm.

The findings also showed no statistically significant difference in mortality, time to hospital discharge, or time to clinical failure between patients who received tocilizumab or placebo. 

At day 28, incidence of infections was 10% and 11% in the tocilizumab and placebo arms, respectively. The incidence of serious infections 5% and 6.3%, respectively. The most common adverse effects reported for tocilizumab in the study were constipation, anxiety, and headache. No new safety signals were identified.

“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,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a statement. “We plan to share this important data with the FDA and other health authorities around the world.”

Reference:

1. Genentech’s Phase III EMPACTA Study Showed Actemra Reduced the Likelihood of Needing Mechanical Ventilation in Hospitalized Patients With COVID-19 Associated Pneumonia. News release. Genentech; September 17, 2020. Accessed September 24, 2020. https://www.gene.com/media/press-releases/14881/2020-09-17/genentechs-phase-iii-empacta-study-showe​