In the latest twist to IL-6 roller coaster, Roche's Actemra fails PhIII Covid-19 Veklury combo trial
Roche is adding another tally mark to the negative column on Actemra’s mixed record in Covid-19.
The IL-6 drug failed to meet the primary endpoint of REMDACTA, where it was paired with Gilead’s approved antiviral Veklury (remdesivir) for the treatment of patients with severe Covid-19 pneumonia. Adding Actemra didn’t improve time to hospital discharge, the company reported, without breaking down the numbers.
Key secondary endpoints weren’t met, either, including likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status.
Actemra — which is already on the market for autoimmune conditions such as rheumatoid arthritis and recently racked up a sixth approval in systemic sclerosis-associated interstitial lung disease — has taken investigators and scientists on a bit of a ride as Roche looked to pitch in on the global fight against Covid-19.
Of the two previous Phase III studies evaluating the drug, one met the primary endpoint while the other didn’t. The successful trial, EMPACTA, focused on hospitalized patients with pneumonia and saw Actemra cut the incidence of death or requiring mechanical ventilation by day 28. In COVACTA, though, the antibody had failed to differentiate from placebo in terms of improving clinical status for a more severe subgroup.
Since the COVACTA readout came first and alongside similar disappointing news from Regeneron and Sanofi around Kevzara, many had assumed it would spell an end to the idea of repurposing the IL-6 class to fight the immune response and lung damage that can result from a coronavirus infection. But Roche — and CMO Levi Garraway — didn’t give up, and still won’t.
“We continue to believe that the totality of data suggests a potential role for Actemra in treating certain patients with COVID-19, and will discuss the results with health authorities,” he said in a statement.
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