US biotech Incyte Corp (Nasdaq: INCY) today announced positive results from the Novartis (NOVN: VX)-sponsored pivotal Phase III REACH2 study evaluating Jakafi (ruxolitinib) in patients with steroid-refractory acute graft-versus-host disease (GVHD).
The study met its primary endpoint of improving overall response rate (ORR) at Day 28 with ruxolitinib treatment compared to best available therapy. No new safety signals were observed, and the ruxolitinib safety profile in REACH2 was consistent with that seen in previously reported studies in steroid-refractory acute GVHD.
Further analysis of the safety and efficacy data is ongoing. Novartis expects to initiate discussions with ex-US regulatory authorities in 2020, and to submit REACH2 results for presentation at an upcoming scientific meeting.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze