The primary endpoint of the trial was improving overall response rate at Day 28 with Jakafi compared to the best available therapy.
Incyte’s stock popped 1.2% at the news that its JAK inhibitor Jakafi (ruxolitinib) hit its primary endpoints in Novartis’ Phase III REACH2 trial in steroid-refractory acute graft-versus-host disease (GVHD).
The trial is sponsored by Novartis, who holds the rights to market ruxolitinib outside the United States. Incyte markets the drug in the U.S. as Jakafi. Currently, ruxolitinib is approved in the U.S. for steroid-refractory acute GVHD in adult and pediatric patients 12 years and older, for polycythemia vera (PV) in adults who haven’t responded well or are intolerant to hydroxyurea, and adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.
The drug is approved in more than 100 countries worldwide. It is approved by the European Commission for PV in adults who are resistant or intolerant to hydroxyurea, and for disease-related splenomegaly or symptoms in adults with MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The drug is approved in 101 countries for MF and in more than 75 countries for PV. More regulatory filings are underway around the world in MF and PV.
The primary endpoint of the trial was improving overall response rate (ORR) at Day 28 with ruxolitinib compared to the best available therapy. No new safety issues were observed, and the safety profile was consistent with data observed in other studies in steroid-refractory acute GVHD.
GVHD occurs after a stem cell transplant from a donor, and the donated cells cause an immune response, attacking the recipient’s organs. There are two major types of GVHD, acute and chronic. They can affect multiple organs, including the skin, gastrointestinal tract and liver.
Earlier in the year the U.S. Food and Drug Administration (FDA) approved ruxolitinib for steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. That was on the basis of the REACH1 trial Another trial, REACH3, is ongoing to evaluate ruxolitinib in steroid-refractory chronic GVHD. Data are expected in 2020.
“GVHD is a challenging and serious disease, and physicians around the world need access to therapies that can improve outcomes for patients,” said Peter Langmuir, group vice president, Targeted Therapies, Incyte. “This positive result of the REACH2 study is excellent news for patients as it further reinforces the potential of ruxolitinib as a treatment option that can provide meaningful results for patients with steroid-refractory acute GVHD.”
REACH2 was a randomized, open-label, multicenter Phase III study. The primary endpoint was ORR at Day 28, which was defined as the proportion of patients showing a best overall response (complete response or partial response). Secondary endpoints included durable ORR at Day 56, ORR at Day 14, duration of response, overall survival and event-free survival.
“As many as half of hematopoietic stem cell transplant recipients development acute GVHD,” said John Tsai, head of Global Drug Development and chief medical officer of Novartis. “We are delighted that Jakavi showed such promise in this very difficult condition especially since few second-line treatment options exist. These impressive results will be part of our regulatory submissions seeking approval in Europe and other countries.”
Novartis indicates it plans to present the full data from REACH2 at an upcoming medical meeting. It also plans to begin discussions with regulatory authorities outside the U.S. in 2020.
