Novartis announces REACH3 trial of Jakavi reaches primary endpoint

Detailed results from the pivotal Phase III REACH3 study demonstrate Jakavi significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory/dependent chronic graft-versus-host disease, or GvHD, compared to best available therapy, Novartis (NVS) announced. The results of REACH3, which the company calls "the first successful, randomized Phase III trial in chronic GvHD," were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition, or ASH. REACH3 is jointly sponsored by Novartis and Incyte (INCY). In REACH3, patients treated with Jakavi achieved significantly greater overall response rate compared to BAT at Week 24, the primary endpoint of the study. Jakavi also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints, the company said. David Feltquate, Head Hematology Development Unit, Novartis, added: "Jakavi is the first treatment to demonstrate efficacy in a large-scale randomized clinical trial in steroid-refractory/dependent chronic GvHD, and with these meaningful data we look forward to advancing discussions with regulatory authorities."