Incyte, a renowned American biopharmaceutical company reportedly announced the results of Phase 3 GRAVITAS-301 study evaluating itacitinib together with corticosteroids in patients suffering from treatment-naïve acute GVHD (graft-versus-host disease). The results did not reach the primary endpoint of improving ORR (overall response rate) at Day 28 when compared to placebo plus corticosteroids.
Itacitinib is a selective and novel JAK1 inhibitor presently in clinical trials for the first-line therapy of patients suffering from chronic and acute GVHD.
Itacitinib integrated with corticosteroids enhanced the ORR in people suffering from treatment-naive acute GVHD. Yet, the difference versus placebo together with corticosteroids was not significant statistically. Also, no difference was observed in NRM (non-relapse mortality) at Month 6. Month 6 is the trial’s vital secondary endpoint, just between therapy and placebo arms.
The safety profile seen in GRAVITAS-301 was consistent with that found in earlier reported trials of itacitinib together with corticosteroids. Anemia (29.8% for itacitinib and 25.0% for placebo) and thrombocytopenia (34.9% for itacitinib and 34.7% for placebo) were the most common adverse events.
Chief Medical Officer at Incyte, Steven Stein, M.D. stated that despite a disappointing trial outcome, the company remains committed to working towards the success of the REACH program for ruxolitinib, that depicted positive outcomes in steroid-refractory acute GVHD. In addition, the company would continue to investigate the work of JAK inhibition in chronic GVHD as well as in prophylactic setting, claims Stein alongside seeking the development of therapies for patients suffering from this debilitating disease.
The pharmaceutical company plans to inform investigators of the outcomes and further operate with them to appropriately conclude the study in a way consistent with the interest of every patient. Information from this trial would be submitted for presentation in an upcoming scientific conference.
Back in September 2019, the company announced positive outcomes from its Phase 2 study for patients suffering from Advanced Cholangiocarcinoma who are previously treated.