Dr. Harding on the Results of the SUMMIT Trial in HER2+ Biliary Tract Cancers

January 17, 2021
James J. Harding, MD

James J. Harding, MD, discusses the results of the ongoing, phase 2 SUMMIT basket trial in HER2-mutant advanced biliary tract cancers.

James J. Harding, MD, regional director of Early Drug Development and medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the results of the ongoing, phase 2 SUMMIT basket trial (NCT01953926) in HER2-mutant advanced biliary tract cancers.

Findings from the SUMMIT trial, which were presented during the 2021 Gastrointestinal Cancers Symposium, revealed a confirmed objective response rate of 16% in 25 evaluable patients with gallbladder cancer, intrahepatic or extrahepatic cholangiocarcinoma, or ampulla of Vater cancer who received neratinib (Nerlynx). The clinical benefit rate was 28%. Additionally, the median progression-free survival was 2.8 months, and the median overall survival was 5.4 months.

These results demonstrate that a subset of patients with HER2-positive biliary tract cancers respond to neratinib, says Harding. Moreover, although the patient population was limited, patients with cholangiocarcinoma and gallbladder cancer had antitumor activity and potentially durable responses with neratinib. Finally, the benefit appeared to be consistent across all HER2 mutation subtypes, concludes Harding.