Roche’s Actemra (Tocilizumab) Fails to Meet Endpoints in REMDACTA Trial Targeting COVID-19 Pneumonia

Roche’s Actemra (Tocilizumab) Fails to Meet Endpoints in REMDACTA Trial Targeting COVID-19 Pneumonia

Although some studies have evidenced to the contrary, the anti-inflammatory drug called Actemra combined with Veklury (remdesivir) did not lead to reduced hospitalization as has been determined with via data from the REMDACTA trial, which looked at the cocktail only remdesivir and standard of care. Moreover, the clinical trial revealed that the Actemra-remdesivir combination failed to achieve secondary targets, such as failing to reduce the probability that a patient would need support from mechanical ventilation or reducing the mortality rate. Roche’s Levi Garraway declared, “Given the global impact of COVID-19 pneumonia on patients, we are disappointed that the REMDACTA study did not meet its endpoints.” While Roche is on the record that the “totality of the data” involving their drug encompassing results from, other data evidences the drug can help at least select patients. Mixed study results lead to varied responses from various medicinal evidence bodies: in some countries, ACTEMRA is embraced for at least select conditions associated with COVID-19 while in other nations, the door is shut. Germany is an example of the latter where the Association of Medical Societies recommends against usage of Actemra for severe COVID-19 while in the U.S., the drug is recommended in select patient cases in hospital or intensive care scenarios.

The drug is approved for rheumatoid arthritis and used in some scenarios involving cancer and adverse immune response post cell therapy. By 2020, the drug became Roche’s fifth top product as measured by revenue—about $3 billion with $600 million deriving from application to treat SARS-CoV-2 infection.

The Study

As reported in the Roche press release the global Phase 3 randomized, double-blind, multicenter REMDACTA study involving Actemra/RoActemra (tocilizumab) plus remdesivir versus placebo plus remdesivir failed to meet the primary endpoint. That is, an improvement in the time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. Conducted in collaboration with Gilead—the maker of remdesivir—the study sponsors didn’t identify any new safety signals.

Other Studies Ongoing

Roche will continue to evaluate data from REMDACTA, COVACTA and EMPACTA trials as well as other studies of Actemra/RoActemra in COVID-19 pneumonia. The EMPACTA study met its primary endpoint, while COVACA failed to do so. Both were published in the New England Journal of Medicine.

Call to Action: For more on these studies, follow the link to the Roche press release.