Phase 3 trial in advanced AML misses primary endpoint
Click Here to Manage Email Alerts
A randomized phase 3 trial designed to evaluate the addition of enasidenib to best supportive care for certain patients with acute myeloid leukemia failed to meet its primary endpoint, according to the agent’s manufacturer.
The multicenter, open-label IDHENTIFY study included adults aged 60 years or older with AML. All patients had IDH2 mutations and either relapsed after or were refractory to second- or third-line AML therapy.
Researchers compared the efficacy and safety of enasidenib (Idhifa, Bristol-Myers Squibb) plus best supportive care with conventional care regimens. These regimens included best supportive care alone or in combination with azacitidine, low-dose cytarabine or intermediate-dose cytarabine.
OS served as the primary endpoint. Key secondary endpoints included overall response rate, EFS, duration of response and time to response.
Results showed no statistically significant improvement in OS among patients treated with enasidenib, an oral targeted inhibitor of the IDH2 enzyme.
Complete results of the trial will be submitted for presentation at a future medical meeting.
“[Although] 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,” Noah Berkowitz, MD, PhD, senior vice president of global clinical development for hematology at Bristol-Myers Squibb, said in a company-issued press release. “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.”
In 2017, the FDA approved enasidenib for treatment of adults with relapsed or refractory AML with IDH2 mutations, detected in up to 19% of patients with AML.
Click Here to Manage Email Alerts