PBYI - Puma Bio's neratinib shows encouraging effect in biliary tract cancers

Puma Biotechnology (PBYI) announces interim results from the biliary tract cancers cohort of the ongoing SUMMIT trial of neratinib. The Phase II SUMMIT basket trial evaluates the safety and efficacy of neratinib administered daily to patients who have HER2 (ERBB2) mutation-positive advanced biliary cancer. The efficacy results from the trial demonstrated that 4 patients had confirmed partial responses and an additional 3 patients had stable disease lasting ?16 weeks.This resulted in an objective response rate of 16% and a clinical benefit rate of 28%.The durations of response were 3.0 months, 3.7 months, and 4.7 months and additionally one patient with gallbladder cancer remains on treatment >80 weeks. Neratinib was seen to be safe and tolerable in patients with advanced biliary tract tumors, and demonstrated activity comparable to current standards of care.The data was presented at the virtual 2021 Gastrointestinal Cancers Symposium hosted by the American Society of Clinical Oncology.Shares up 3% premarket.

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Puma Bio's neratinib shows encouraging effect in biliary tract cancers