Genentech announced that a phase 3 study investigating tocilizumab (Actemra®) for the treatment of hospitalized patients with severe coronavirus disease 2019 (COVID-19) associated pneumonia did not meet its primary and key secondary end points.
The multicenter, randomized, double-blind COVACTA study compared the efficacy and safety of tocilizumab, an interleukin-6 receptor antagonist, to placebo in hospitalized adult patients with severe COVID-19 pneumonia. Patients were randomized to receive 1 intravenous infusion of either tocilizumab or placebo, in addition to standard of care. The primary end point was clinical status as measured by a 7-category ordinal scale; key secondary end points included mortality, as well as mechanical ventilation and intensive care unit (ICU) variables.
Results showed that the difference in clinical status between patients treated with tocilizumab and those who received placebo was not statistically significant (odds ratio 1.19; 95% CI, 0.81-1.76; P =.36). Additionally, no statistically significant differences were observed between the 2 groups with regard to mortality rate (19.7% with tocilizumab vs 19.4% with placebo; P =.9410) or ventilator-free days (22 days with tocilizumab vs 16.5 days with placebo; P =.3202).
With regard to safety, the tocilizumab and placebo groups had similar rates of infection (38.3% vs 40.6%, respectively), with serious infection rates of 21.0% and 25.9%, respectively. The most common adverse events in the tocilizumab treatment arm were COVID-19 pneumonia (10.5%), hypertension (6.4%), pneumonia (5.8%), acute kidney injury (5.8%) and diarrhea (5.8%).
“We are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week 4,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “We will continue to generate evidence to provide a more complete understanding of Actemra in COVID-19 associated pneumonia.”
Genentech is also investigating tocilizumab for COVID-19 associated pneumonia in the phase 3 REMDACTA and EMPACTA trials and the phase 2 MARIPOSA trial.
Actemra is currently approved for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis or active polyarticular juvenile idiopathic arthritis, giant cell arteritis, and chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome.
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1. Genentech provides an update on the phase III COVACTA trial of actemra in hospitalized patients with severe COVID-19 associated pneumonia. https://www.businesswire.com/news/home/20200728006091/en/Genentech-Update-Phase-III-COVACTA-Trial-Actemra. Published July 29, 2020. Accessed July 29, 2020.