Incyte announced that the Phase 3 RUXCOVID study evaluating the safety and efficacy of ruxolitinib (Jakafi), a JAK1/JAK2 inhibitor, 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. 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)1.
In addition, there was no clinically relevant benefit observed among secondary and exploratory endpoints, including mortality rate by Day 29 and time to recovery, defined as the first day a patient met the criteria for category 0 (Uninfected – No clinical or virological evidence of infection), 1 (Ambulatory – No limitation of activities), or 2 (Ambulatory – Limitation of activities) on the 9-point ordinal scale1. Ruxolitinib was generally well tolerated and no significant safety concerns were identified1. A comprehensive analysis including safety data is ongoing. The results of this study do not affect other ongoing non-COVID-19 related ruxolitinib clinical trials or approved uses of ruxolitinib.
“Given the urgent nature of the COVID-19 pandemic and the need for treatments for patients hospitalized with severe COVID-19 associated cytokine storm, the results of the RUXCOVID study are disappointing. However, we hope that these findings will contribute to the scientific understanding of this complex disease and to the collective efforts of the biopharma industry to find solutions that improve outcomes for patients with COVID-19,” said Steven Stein, Chief Medical Officer, Incyte
The RUXCOVID study is complete. The data will be further analysed to determine any potential impact on other studies of ruxolitinib in patients with COVID-19 and will be submitted for publication.
Ruxolitinib (Jakafi) is approved by the US Food and Drug Administration for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. It is marketed by Incyte in the US; ruxolitinib (Jakavi) is licensed to Novartis ex-US.