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ASCO 2022 | Final results from the phase 2 SUMMIT basket trial: targeting HER2+ advanced BTCs with neratinib

James J. Harding, MD, Memorial Sloan Kettering Cancer Center, New York, NY, discusses results from the SUMMIT study (NCT01953926), a Phase II study evaluating neratinib and fulvestrant for HER2-mutant, solid tumors. In this update, Dr Harding provides and overview of use of neratinib in patients with advanced, HER2-mutant biliary tract cancers, whereby patients achieved an overall-response rate of approximately 16%. This interview took place at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting in Chicago, IL.

Transcript (edited for clarity)

SUMMIT is a multicenter Phase II basket study of neratinib, which is a pan-HER2 inhibitor in patients with solid tumors that harbor missense mutations in ERBB2 or HER2. It’s for HER2-mutant solid tumors. This study has been going on for many years, enrolling many cohorts of patients. What was presented here at ASCO 2022 was the final results from the biliary tract cohort. In that study, we treated 25 patients with HER2-mutant biliary tract cancers, all heavily pretreated...

SUMMIT is a multicenter Phase II basket study of neratinib, which is a pan-HER2 inhibitor in patients with solid tumors that harbor missense mutations in ERBB2 or HER2. It’s for HER2-mutant solid tumors. This study has been going on for many years, enrolling many cohorts of patients. What was presented here at ASCO 2022 was the final results from the biliary tract cohort. In that study, we treated 25 patients with HER2-mutant biliary tract cancers, all heavily pretreated. We observed that the objective response rate was about 16% and that a subset of patients benefited with tumor responses. We also conducted genomic analysis and proposed some mechanisms of resistance to the therapy. Overall, there’s anti-tumor activity for neratinib in this very rare subset of biliary tract cancers. It’s a platform of which to develop new therapies.

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