Positive data published for Jakavi in chronic GvHD

pharmafile | July 15, 2021 | News story | |   

Incyte and Novartis have announced the publication of positive data from Phase III trials in NEJM, demonstrating Jakavi (ruxolitinib) significantly improved outcomes in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) compared to best available therapy (BAT).

The REACH3 study, jointly sponsored by Incyte and Novartis, study found that treatment with Jakavi led to significant improvements in overall response rate (ORR) at week 24. Furthermore, best overall response rate at any time up to week 24 was achieved in 76.4% of patients in the Jakavi arm compared to 60.4% in the BAT arm.

The study also found that patients on Jakavi achieved longer failure-free survival than patients receiving BAT, and also Jakavi-treated patients had greater improvements in self-reported symptoms compared to BAT.

Dr Robert Zeiser, from the University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, said: “Patients with chronic GvHD can experience severe and life-threatening symptoms in different organs around the body, which makes the disease more difficult to treat and increases the risk of poor outcomes.

“With these new results from REACH3, we can see more clearly the potential benefits of what may become a new standard of care for chronic GvHD patients who have not adequately responded to first-line steroids.”

Ruxolitinib is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases, and is approved by the FDA for treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis, including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF, and for treatment of steroid-refractory acute GvHD in adult and pediatric patients 12 years and older.

Jakavi is marketed by Novartis outside of the US, and by Incyte inside the US as Jakafi.

Susanne Schaffert, PhD, President of Novartis Oncology, said: “These new Jakavi data underscore its potential benefits and the importance of making it available to patients at risk for an all-too-common and life-threatening complication of stem cell transplants.

“We are pleased that regulatory submissions are underway and will continue to work toward wide accessibility of this important new medicine for GvHD.”

GvHD is an immune condition that occurs after transplant procedures when immune cells from the donor (known as the graft or graft cells) attack the recipient patient host’s tissues; the disease is a side effect that is common after an allogeneic bone marrow transplant (stem cell transplant).

Tissues from healthy donors are checked prior to bone marrow transplant to see how closely matched they are to the host’s own cells. When there is a close match in certain genetic markers, the risk of the disease is lower. The disease can range from mild to life-threatening in severity and there are two types of GVHD: acute GVHD and chronic GVHD.

The chance of developing GVHD is around 30%-40% when the donor and recipient are related and around 60%-80% when the donor and recipient are not related.

Kat Jenkins

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