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Jakafi outperforms best available therapy in steroid-refractory/dependent chronic graft-versus-host disease

pharmafile | December 7, 2020 | News story | Research and Development, Sales and Marketing Incyte, Jakafi, Novartis 

The first Phase 3 findings have been revealed for Jakafi (ruxolitinib) in the treatment of steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD), a condition which can arise following an allogenic stem cell transplant when the donated cells trigger an immune reaction in the recipient.

In a Phase 3 study sponsored by both Novartis and Incyte, Jakafi was shown to generate an overall response rate (ORR) of 49.7% at 24 weeks, a significant improvement over the 25.6% ORR achieved by those receiving best available therapy (BAT).

Furthermore, Jakafi was associated with a 24.2% improvement in patient-reported symptoms over 11% with BAT, and 76.4% receiving the medication achieved a response compared to 60.4% with BAT within 24 weeks.

Both median failure-free survival and median duration of response were not reached in the Jakafi group, but stood at 5.7 months and 6.2 months in patients receiving BAT.

“The damaging and sometimes deadly effects of chronic GVHD following stem cell transplant present significant treatment challenges, particularly for the nearly half of patients who do not adequately respond to steroid treatment,” remarked Dr Robert Zeiser of the Department of Haematology, Oncology and Stem Cell Transplantation at University Hospital Freiburg. “Based on the compelling REACH3 results, we now have a potential new standard of care for these patients.”

The findings from the study were presented at the 2020 American Society of Hematology Annual Meeting & Exposition (ASH 2020).

Matt Fellows

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