By Robb M. Stewart 



  Bristol Myers Squibb Co. said Tuesday its international "IDHENTIFY" Phase 3 study of its treatment for patients with a form of acute leukemia didn't meet the primary endpoint. 


  The company said it would complete a full evaluation of the data and work with investigators to present detailed results at a future medical meeting. 


  Noah Berkowitz, senior vice president of global clinical development, hematology, said the outcome of the study was disappointing but the company remained confident in IDHIFA's established role as a treatment option for patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation. 


  In August 2017, Bristol Myers Squibb received full approval in the U.S. for IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation as detected by a U.S. Food and Drug Administration-approved test. It is also approved in Australia and Canada. 


  Bristol Myers Squibb conducted an international, multicenter, open-label, randomized, Phase 3 study comparing efficacy and safety versus conventional care regimens in subjects 60 years or older with acute myeloid leukemia refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase mutation. The primary endpoint of the study was overall survival, and key secondary endpoints included overall response rate, event-free survival, duration of response and time to response. 


  The company said the study of IDHIFA plus best supportive care didn't meet the primary endpoint, while the safety profile of IDHIFA was consistent with previously reported findings. 


  The company's shares were 0.2% lower in premarket trading, after closing Monday at $62.41. 


  Write to Robb M. Stewart at robb.stewart@wsj.com