Takeda’s phase-III Panther trial unable to achieve primary endpoint of event-free survival

Takeda Pharmaceutical recently announced that the Phase-III Panther (Pevonedistat-3001) study did not achieve pre-defined statistical significance for the primary endpoint of event-free survival (EFS). The trial evaluated whether the combination of pevonedistat plus azacitidine as first-line treatment for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and low-blast acute myeloid leukemia (AML) improved EFS versus azacitidine alone. An event in the trial is defined as death or transformation to AML in participants with higher-risk MDS or CMML, whichever occurs first, and death in participants with AML, according to a company statement.

Speaking on the result, Chris Arendt, PhD, Head, Oncology Cell Therapy and Therapeutic Area Unit, Takeda, said, “While we are disappointed with this outcome, we are continuing to gain a greater understanding of the full data set and hope that findings from this phase-III study will provide information to help guide research and development for potential treatment options for these underserved patient populations. We would like to thank the patients, families, advocacy organisations and investigators that participated in this trial, without whom this meaningful research would not have been possible. Takeda remains committed to conducting important research and transforming the lives of patients with cancer.”

Full data results will be submitted for presentation at an upcoming medical congress. Investigators have been informed of the outcome so they can discuss the potential impact with study participants. Takeda will work with investigators who will determine the most appropriate action for each individual patient enrolled in the study, added the statement.