Incyte/Novartis' Jakafi study in COVID-19 misses endpoints

 

• Incyte's (NASDAQ:INCY) Phase 3 RUXCOVID study evaluating the safety and efficacy of ruxolitinib (Jakafi) plus standard-of-care (SoC) as a treatment for patients 12 years and older with COVID-19 associated cytokine storm did not meet its primary endpoint. RUXCOVID study was sponsored by Incyte in U.S. and Novartis (NYSE:NVS) outside of U.S.
• Initial data show that there was no reduction in the proportion of patients receiving ruxolitinib plus SoC who experienced severe complications including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) care by Day 29, compared to SoC treatment alone (12.0% vs. 11.8% [OR: 0.91 [95% CI: 0.48-1.73], P=0.769, respectively).
• In addition, there was no clinically relevant benefit observed among secondary and exploratory endpoints, including mortality rate by Day 29 and time to recovery.
• Ruxolitinib was generally well tolerated and no significant safety concerns were identified. A comprehensive analysis including safety data is ongoing.
• The data will be further analyzed to determine any potential impact on other studies of ruxolitinib in patients with COVID-19, and will be submitted for publication.
• Incyte launched study of Jakafi for COVID-19 complication in April 2020.
• https://seekingalpha.com/news/3643920-incyte-novartis-jakafi-study-in-covidminus-19-fails-to-meet-endpoints