Novartis, Incyte's Jakafi boosts its case in graft-versus-host disease with another phase 3 win

Jakafi scored an FDA nod in graft-versus-host disease in May. (Novartis)

Novartis and Incyte's JAK inhibitor Jakafi has had a whirlwind few weeks as it rolls into a late-stage trial as a possible therapy for cytokine storm in COVID-19 patients. But Jakafi is also strengthening its hand in graft vs. host disease, where it scored its third approval earlier this year. 

Patients treated with Jakafi saw a significant reduction in symptoms of their acute graft vs. host disease (GVHD) after 28 days compared with patients treated with the best available therapy after not responding to corticosteroids, according to phase 3 data published Wednesday in The New England Journal of Medicine. 

Sixty-two percent of patients treated with Jakafi responded to the therapy compared with 39% of patients on best available therapy, Novartis said in a release. After 56 days, 40% of Jakafi patients saw lasting benefits while only 22% of patients in the control arm had continued to respond. 

Jakafi also significantly extended patients' lives to a median five months compared with the median one-month mortality rate for patients with acute GVHD, the companies said. Jakafi posted similar rates of adverse events as previous GVHD studies with 11% of patients dropping out due to complications compared with 5% on best available therapy. 

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The partners plan to present data from the phase 3 Reach2 trial at the European Society for Blood and Marrow Transplantation Annual Meeting in late September in Madrid.

Jakafi is marketed in the U.S by Incyte while Novartis holds commercial rights outside the U.S. under the brand name Jakavi. 

Reach2 comes as the first follow-up study after the FDA granted Jakafi an approval in May in acute GVHD on the strength of the phase 2 Reach1 trial. 

In that study, 57% of patients treated with a combination of Jakafi and corticosteroids responded to therapy at 28 days after failing steroid monotherapy. 

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GVHD made three indications for Jakafi, which is also approved to treat the bone marrow disorders polycythemia vera and myelofibrosis. The approval came three months later than expected after the FDA extended its review to consider newly submitted data.

The partners plan to roll out data from the phase 3 Reach3 study evaluating Jakafi in steroid-refractory chronic GVHD in the second half of the year, the companies said. 

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Jakafi has scored recent interest as a possible therapy for COVID-19, with Novartis and Incyte recently rolling the drug into late-stage clinical trials. 

On Friday, the drugmakers launched a phase 3 Jakafi trial in COVID-19 patients with cytokine storm, an immune system over-response that can lead to respiratory failure. The study, dubbed Ruxcovid, will evaluate a combination of Jakafi and standard of care against standard of care alone to reduce the proportion of patients who die, or require mechanical ventilation or intensive care, after 29 days, Incyte said in a release.

Incyte said it currently has enough Jakafi supply to meet patient needs and "is increasing manufacturing efforts to respond to anticipated supply needs related to COVID-19 studies and working closely with distribution partners to monitor the supply of (the drug)."

Incyte late last week scored an approval for rare bile duct cancer med Pemazyre, more than a month before its approval date. Incyte's drug targets the fibroblast growth factor receptor 2 (FGFR2), and bile duct cancers with FGFR2 rearrangements are believed to affect between 2,000 and 3,000 patients in the U.S., Europe and Japan, Incyte said. On Friday, the FDA also approved a Pemazyre companion diagnostic from Foundation Medicine.