Jakafi failed the primary endpoint in a Covid-19 study. But Incyte is still going to FDA with a compassionate use pitch
Jakafi disappointed Incyte once when it failed to prevent severe complications of Covid-19. The JAK inhibitor has fallen short again in another Phase III study, failing to keep a more critical subgroup of patients from dying.
The DEVENT study recruited 211 people with acute respiratory distress syndrome on mechanical ventilation, and set out to see if either a 5mg dose or a 15mg dose of Jakafi could reduce mortality through day 29 compared to standard of care alone. In today’s world, that means remdesivir for 55% of study patients and corticosteroids for 90%.
Adding Jakafi, investigators found, did not improve that metric in the overall study population by a statistically significant margin when you adjust for ARDS severity between the two treatment arms versus placebo.
Incyte reported an odds ratio of 0.42 in the 5mg arm and 0.46mg in the 15mg arm, respectively, with the confidence interval crossing over 1.0 on the upper bounds.
They found hope, however, in the US study population: There was a statistically significant improvement in mortality in each of the arms, with odds ratios of 0.39 (46.7% versus 66.7%, p=0.189) and 0.43 (47.1% vs 66.7%, p=0.0215), respectively. With 191 patients, that cohort accounted for the majority of the study population.
Digging even deeper to try and pull positive numbers, the company added that a post hoc analysis pooling both the doses together would yield a statistically significant result (odds ratio 0.47, 53.6% vs 70.7%, p=0.0244) — although the confidence interval came close to the edge at 0.996.
While Incyte didn’t specify next development or regulatory steps, all of that apparently supports launching a compassionate use program for patients with Covid-19 associated ARDS, which is what they will be proposing to the FDA.
“There remains a significant unmet medical need for treatments that may potentially improve survival outcomes for patients suffering from severe COVID-19 related complications, specifically those requiring mechanical ventilation,” Incyte CMO Steven Stein said in a statement.
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