Incyte's cash cow Jakafi chugs along with positive frontline results for GVHD
Five months after the FDA approved Incyte to expand its flagship Jakafi drug to patients with steroid-refractory acute graft-versus-host disease (GVHD), the company announced positive topline results from its Phase III study.
“This announcement, while a positive, is not surprising given the recent label expansion for Jakafi in the U.S. into this setting based on results from the single-arm REACH1 trial,” Baird’s Brian Skorney wrote, adding that it should allow Novartis, Incyte’s partner, to begin registering the drug abroad.
Jakafi is a JAK inhibitor that has thus far been approved to treat polycythemia vera and forms of myelofibrosis. The drug is Incyte’s greatest revenue stream — bringing in nearly $400 million per quarter — and has kept Incyte sailing despite setbacks across their pipeline.
The latest indication, GVHD, is an ailment that afflicts some allogeneic stem cell transplant recipients. The stem cells view the host as foreign and attack. In the acute form of the disease, this can cause rashes, discoloration and vomiting. Symptoms for the chronic form can be worse, potentially bringing shortness of breath, pain and muscle weakness, among other ailments.
Immune-suppressing steroids are the main existing treatment, but there are few options for the large percentage of patients who don’t respond to steroids.
The randomized, open-label trial of 310 patients looked at overall response rate at day 28. Secondary endpoints include ORR at day 14 and durable ORR at day 56. In the PhaseII trial that pushed Jakafi to FDA approval for GVHD, the response rate at day 28 was 55% of 71 patients, with the median duration of response for responsive patients who were then observed for six or more months being 345 days.
A second Phase III trial, Reach3, is underway for chronic steroid-refractory GVHD. The drug is not yet FDA-approved for chronic GVHD.
Incyte revealed that an interim safety and efficacy analysis was conducted and an independent commission recommended the Reach3 trial continue. The results are projected to appear in 2020, as opposed to earlier guidance that suggested an announcement by the end of 2019. Skorney said the new timeline could indicate patients are performing better than anticipated.
Jakafi is also in pivotal trial stage for use on essential thrombocythemia and cholangiocarcinoma. The drug is at the proof of concept stage for bladder cancer, 8p11 MPN, follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma.