- An anti-inflammatory medicine from Roche appeared to help keep people hospitalized with COVID-19 associated pneumonia from needing intensive breathing support in a clinical study, the Swiss drugmaker claimed Friday in a surprise result that goes against prior clinical trial results.
- Treatment with Roche's drug, called Actemra, reduced the likelihood study participants would progress to mechanical ventilation or death by 44% when compared to placebo. Roche said it plans to discuss the data with regulators in the U.S. and abroad.
- But the study didn't show Actemra helped more patients live, nor did treatment appear to hasten discharge from hospital. Prior to Friday's results, Actemra had failed to show a benefit in a different COVID-19 study testing the drug in a similar setting. Sanofi and Regeneron recently gave up on testing Kevzara, which works similarly to Actemra, after disappointing data.
For months, researchers and drugmakers have come up empty in their efforts to recreate promising findings from China and France that the rheumatoid arthritis medicine Actemra may have helped keep severely ill COVID-19 alive or off of breathing support.
Those findings, from small, flawed studies in the early days of the coronavirus pandemic, were part of an early wave of attempts by clinicians to repurpose existing medicines for COVID-19. They sparked a global hunt to see if drugs like Actemra, known as IL-6 inhibitors, could prove helpful in treating symptoms of the disease in more rigorous placebo-controlled trials.
But several high-profile studies failed, reflecting the difficulty of trying to tame a new disease with medicines that weren't specifically designed to treat it. Sanofi and Regneneron reported negative results from three trials of their IL-6 inhibitor, Kevzara, and stopped researching the drug in COVID-19 earlier this month. In July, Actemra came up short in a 450-patient study called COVACTA.
Roche kept other studies going, however, noting positive trends in COVACTA, including an apparent reduction in the need for mechanical breathing support among Actemra-treated patients. That persistence has now seemingly borne fruit with Friday's results, although the benefits reported appear modest.
The study, called EMPACTA, enrolled patients hospitalized with COVID-19 and lower than normal levels of oxygen in the blood, but who didn't need breathing support. Some 85% of the 389 recruits in EMPACTA were minorities. Roche said the majority of participants were Hispanic with "significant" Native American and Black representation, all groups that are often underrepresented in clinical trials and have been hit hardest by the pandemic.
Roche found about 12% of those who received Actemra plus standard of care needed breathing support or died through four weeks, compared to roughly 19% of those who go standard treatment alone, meeting the trial's goal.
But the results didn't show a statistically significant benefit on any of the secondary measures studied, such as the time needed for patients to recover and leave the hospital. Most notably, Roche said about 10% of Actemra-treated patients had died by day 28, versus roughly 9% of placebo-treated patients.
Roche provided only summary results, which will be submitted for publication in a peer-reviewed journal. But the pharma's plans to share the data with public health authorities suggest an interest in discussing potential opportunities for an emergency authorization.
While Roche may not have a strong case, there is precedent for the Food and Drug Administration considering mixed results. In May, the agency cleared Gilead's antiviral Veklury for emergency use based on data showing it could speed recovery from COVID-19, despite the drug not clearly reducing the risk of death.
The FDA may soon face another tough decision, too, after Eli Lilly this week showed in a study that adding its arthritis drug Olumiant to Veklury might help reduce virus levels.
Roche is also testing Actemra alongside Veklury in hospitalized COVID-19 patients in another Phase 3 trial called REMDACTA.