Incyte's Ruxolitinib Fails To Beat Placebo In Improving Mortality In Critically-Ill COVID-19 Patients

Incyte Corporation NASDAQ: INCY) announced results from the Phase 3 DEVENT study evaluating two doses of ruxolitinib (5mg and 15mg) plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).

• While improvement in mortality for each dose compared to placebo was trending positive, the study failed to meet its primary endpoint.
• Mortality due to any cause through day 29 between the two treatment arms versus placebo was (55.2% vs. 74.3%) in the 5mg arm and 51.8% vs. 69.6% in the 15mg arm.
• In the U.S. study population (N=191), clinically and statistically significant improvement in mortality was observed in each of the 5mg (46.7% vs. 69.1%) and 15mg treatment arms (47.1% vs. 66.7%) versus placebo, respectively.
• Additionally, a post-hoc analysis of the overall study population pooling both the 5mg and 15mg ruxolitinib arms together versus placebo showed a statistically significant improvement in mortality (53.6% vs. 70.7%)
• 55% of study patients received remdesivir, and 90% of study patients received corticosteroids before or during the study.
• The most common adverse events on the ruxolitinib arms, compared to placebo, were anemia (20.7% vs. 22.2%), increased alanine aminotransferase (14.6% vs. 13.3%), increased aspartate transaminase (14.0% vs. 8.9%), and hypertension (11.6% vs. 11.1%), respectively.
• The company plans to make ruxolitinib available to eligible patients in the U.S. via an Expanded Access Program pending agreement with the FDA.
• Price Action: INCY shares closed 2.4% lower at $78.25 on Thursday.