A Phase 3 clinical trial, IDHENTIFY, evaluating Bristol-Myers Squibb (NYSE:BMY) unit Celgene’s IDHIFA (enasidenib) plus best supportive care (BSC) compared to conventional care regimens in patients with relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation failed to achieve the primary endpoint of overall survival (OS).
“While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol-Myers Squibb. “AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”
Complete results will be submitted for presentation at a future medical conference.
A Phase 3 clinical trial, IDHENTIFY, evaluating Bristol-Myers Squibb (NYSE:BMY) unit Celgene’s IDHIFA (enasidenib) plus best supportive care (BSC) compared to conventional care regimens in patients with relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation failed to achieve the primary endpoint of overall survival (OS).
“While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol-Myers Squibb. “AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”
Complete results will be submitted for presentation at a future medical conference.
The FDA approved the IDH2 inhibitor three years ago for IDH2 mutation-positive AML patients.
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