Bristol Myers Squibb Announces Phase 3 IDHENTIFY Trial of Idhifa (Enasidenib) Fails to Meet Primary Endpoint in IDH2-Mutant Relapsed or Refractory AML

August 26, 2020 News /Bio ValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced the evaluation of the targeted anticancer drug Idhifa (enasidenib) for the treatment of IDH2 mutation-positive, relapsed or refractory acute myeloidLeukemiaThe Phase III IDHENTIFY study in (R/R AML) did not meet the primary endpoint of overall survival (OS).

In August 2017, Idhifa received full approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) whose IDH2 mutations have been confirmed by an FDA-approved diagnostic test.Idhifa is the first and onlyFDADrugs Approved for the Treatment of IDH2 Mutation-Positive R/R AML Patients, accounting for approximately 19% of AML patients. Idhifa has also been approved in Australia and Canada.

The IDHENTIFY study (NCT02577406) was an international, multicenter, open-label, randomized Phase III trial conducted in patients aged ≥60 years with IDH2 mutation-positive acute myeloid leukemia (AML) who were refractory to second- or third-line AML therapies or had relapsed after treatment. The study evaluated the efficacy and safety of Idhifa combined with best supportive care (BSC) versus conventional care regimens (including: BSC alone, BSC plus azacitidine, low-dose cytarabine plus BSC, and intermediate-dose cytarabine plus BSC). The primary endpoint was overall survival (OS), and key secondary endpoints included overall response rate (ORR), event-free survival (EFS), duration of response (DOR), and time to response.

The results showed that the study did not meet its primary endpoint: Idhifa in combination with best supportive care (BSC) did not significantly improve overall survival (OS) compared to the conventional care regimen. In this study, the safety profile of Idhifa was consistent with previously reported findings.

Bristol-Myers Squibb will conduct a comprehensive evaluation of the study data and collaborate with the study investigators at future medicalMeetingDetailed results will be published above.

Dr. Noah Berkowitz, Senior Vice President of Global Clinical Development in Hematology at Bristol-Myers Squibb, stated, “Although we are disappointed with the results of the IDHENTIFY study, we remain confident in the established role of Idhifa as a treatment option for patients with relapsed or refractory acute myeloid leukemia (AML) harboring IDH2 mutations, and we thank all those who participated in the study. AML is one of the most difficult-to-treat hematologic cancers, and we are committed to further research to raise the standard of care for patients with this aggressive disease.”

Acute Myeloid Leukemia (AML) is the most common type of acute leukemia. AML originates in the bone marrow but rapidly enters the bloodstream. Unlike normal blood cell development, the rapid accumulation of abnormal white blood cells in the bone marrow of AML patients can interfere with the production of normal blood cells, leading to a reduction in healthy white blood cells, red blood cells, and platelets.

Acute myeloid leukemia (AML) is a complex and heterogeneous disease associated with various genetic mutations, such as isocitrate dehydrogenase 2 (IDH2) mutations. It typically progresses rapidly and can be fatal if left untreated. IDH2 mutations are present in up to 19% of AML cases. The high relapse rate of AML indicates that the disease is likely to recur after patients achieve an initial response to treatment, highlighting an unmet need for targeted therapeutic options. (Bioon.com)

Original Source: Bristol-Myers Squibb Provides Update on Phase 3 IDHENTIFY Trial in Patients with Relapsed or Refractory Acute Myeloid Leukemia