Novartis and Incyte’s ruxolitinib fails to show benefit in COVID-19 at Phase 3

pharmafile | December 14, 2020 | News story | Research and Development, Sales and Marketing COVID-19, Incyte, Novartis 

Novartis has unveiled that its JAK 1/2 tyrosine kinase inhibitor ruxolitinib fell short of its main efficacy goal in the treatment of COVID-19 at Phase 3, when added to standard of care (SoC).

A total of 432 patients were enrolled in the RUXCOVID study globally. According to the results of the study, 12% of trial participants receiving the ruxolitinib combo required mechanical ventilation, intensive care unit (ICU) care, or died by day 29, compared to 11.8% of participants receiving placebo plus SoC. As Novartis admitted, participants saw no statistically significant reduction in these metrics with ruxolitinib over placebo.

Additionally, the company confirmed that the combo also fell short in its secondary endpoints, failing to generate clinically relevant benefit in time to recovery or mortality rate after 29 days.

“While the RUXCOVID trial did not give us the results we hoped for, we will continue working with the medical community to analyse its findings to better understand COVID-19 and the role of JAK inhibition,” explained John Tsai, Head Global Drug Development and Chief Medical Officer at Novartis.

Novartis secured the rights to the therapy outside of the US from Incyte, and sells it under the brand name Jakavi in Europe. In that market, it is already approved for the treatment of polycythemia vera (PV) in adults who are resistant to or intolerant of hydroxyurea, and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF).

“Given the urgent nature of the COVID-19 pandemic and the need for treatments for patients hospitalised with severe COVID-19-associated cytokine storm, the results of the RUXCOVID study are disappointing,” remarked Dr Steven Stein, Incyte’s Chief Medical Officer. “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.”

Matt Fellows

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