Novartis AG (NYSE:NVS) has announced its third phase REACH3 study results, which showed that Jakavi® significant failure-free survival improvements in patients with steroid-refractory chronic graft-versus-host disease (GvHD) relative to best available therapy (BAT).
Novartis reports positive REACH3 results of Jakavi in chronic GvHD
The company presented the REACH3 results at the Annual 62nd American Society of Hematology Meeting & Exposition. REACH3, a Novartis and Incyte sponsored study, produced the first successful Third phase study in chronic GvHD.
Dr. Robert Zeiser, Department of Haematology, Oncology and Stem Cell Transplantation, University Hospital, Freiburg, stated that chronic GvHD could sometimes have damaging and deadly effects after stem cell transplant. This presents significant treatment challenges, especially for almost half of the patients who do not adequately respond to steroid treatment. Zeiser said that based on the encouraging REACH3 study results, there is now a potential standard of care for the patient population.
Patients who received Jakavi in the REACH3 study attained a significant overall response rate compared to those on BAT at week 24. Interestingly Jakavi demonstrated statistically significant and meaningful enhancements in secondary endpoints.
Novartis advancing talks with regulators for Jakavi approval
Novartis Head of Haematology Development Division, David Feltquate, stated that the study results were impressive and complemented past positive findings in chronic GvHD. They define the important role Jakavi can have in improving patient outcomes for those facing this difficult to treat disease. He added that Jakavi is the first treatment to show efficacy in a randomized large-scale clinical study in steroid-refractory/dependent chronic GvHD. With the encouraging data, David said that the company is looking forward to advancing discussions on the approval of Jakavi with regulatory agencies.
There were no new safety concerns observed in the study, and reported adverse events were consistent with Jakavi’s known safety profile. The most common adverse events included anemia, hypertension, thrombocytopenia, and pyrexia. Mortality rates across Jakavi vs. BAT treatment arms were the same but deaths reported due to chronic GvHD were higher in the Jakavi arm.