Phase III REMDACTA Trial of Roche's Actemra Combined with Gilead's Veklury Fails to Meet Primary Endpoint in Severe COVID-19 Patients

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On March 10, Genentech, a member of the Roche Group, announced that the Phase III REMDACTA study evaluating the anti-inflammatory drug Actemra (tocilizumab) in combination with Veklury (remdesivir) for the treatment of patients with severe COVID-19 pneumonia failed to meet its primary and key secondary endpoints.

REMDACTA is a global, randomized, double-blind, multicenter Phase III study (NCT04409262) conducted in hospitalized patients with severe COVID-19 pneumonia receiving standard of care, aiming to evaluate the efficacy and safety of Actemra plus Veklury versus placebo plus Veklury. The study was conducted in collaboration with Gilead Sciences. The primary endpoint was improvement in time to discharge by Day 28. Key secondary endpoints included the likelihood of death, the likelihood of progression to mechanical ventilation or death, and clinical status. Clinical status was assessed using a 7-point ordinal scale that tracks patients’ clinical condition based on the need for intensive care and/or mechanical ventilation, as well as the need for supplemental oxygen. Patients were followed for 60 days after randomization.

The results showed that the study did not meet its primary endpoint: by Day 28, the Actemra + Veklury treatment group demonstrated no improvement in length of hospital stay compared to the placebo + Veklury treatment group. Furthermore, the study also failed to meet its key secondary endpoints. No new safety signals were identified for Actemra in this study.

The full results of the study will be published in a peer-reviewed journal later this year. Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, stated: “Given the broad impact of COVID-19 pneumonia on patients, we are disappointed that the REMDACTA study did not meet its endpoint. We continue to believe that all data suggest Actemra may play a role in treating certain patients with COVID-19, and we will discuss the results with health authorities. We thank our partners at Gilead, as well as all patients, investigators, and healthcare professionals for their participation.”

Genentech will continue to evaluate data from the REMDACTA, COVACTA, and EMPACTA studies, as well as other studies of Actemra for the treatment of COVID-19 pneumonia. Among these, the EMPACTA study met its primary endpoint, whereas the COVACTA study did not meet its primary endpoint. The results of both studies were recently published in The New England Journal of Medicine.

Veklury is an antiviral drug developed by Gilead Sciences that inhibits the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19). Veklury has currently received approval from the U.S. Food and Drug Administration (FDA) for the treatment of pediatric and adult patients aged 12 years and older, weighing at least 40 kg, who require hospitalization for COVID-19.

Actemra is a monoclonal antibody drug developed by Roche, approved for multiple inflammatory indications. The drug inhibits IL-6-mediated signaling by targeting and blocking the interleukin-6 receptor (IL-6R). IL-6 is a cytokine associated with various inflammatory diseases and may play a role in the hyperactive inflammatory response in the lungs of patients with severe or critical COVID-19.

In addition to Actemra, Sanofi/Regeneron’s similar drug, Kevzara, was also studied for COVID-19. Last September, the global Phase III trial of Kevzara in hospitalized patients with severe and critical COVID-19 failed. Subsequently, both parties discontinued further research on Kevzara for the treatment of COVID-19.

Reference Source: Genentech Provides Update on the Phase III REMDACTA Trial of Actemra Plus Veklury in Patients With Severe COVID-19 Pneumonia