On June 4, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that final results from the Phase II SUMMIT ‘basket’ trial, assessing the efficacy of neratinib in treatment-refractory patients with metastatic biliary tract cancers with somatic HER2 mutations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Puma Biotechnology, JUN 4, 2022, View Source [SID1234615575]). The presentation entitled "Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT ‘basket’ trial" was presented at the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Poster Session (#4079) by James J. Harding, MD, Regional Director, Early Drug Development, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, an investigator of the trial. A copy of this poster presentation is available on the Puma website.
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Neratinib is an irreversible, pan-HER, oral tyrosine kinase inhibitor. The Phase II SUMMIT trial is an open-label, single-arm, multi-cohort, ‘basket’ trial of neratinib in patients with solid tumors that harbor oncogenic somatic HER2 mutations. The study included a cohort of treatment-refractory patients with metastatic biliary tract cancers (BTCs). While HER2 overexpression is associated with an increased risk of disease recurrence in patients with resected BTC, there is limited data on targeting HER2 mutations in these patients.
Efficacy results from the BTC cohort of 25 patients (11 cholangiocarcinoma, 10 gallbladder, 4 ampullary cancers) demonstrated an overall response rate (ORR) of 16%, 95% CI 4.5-36.1%), median progression free survival (PFS) of 2.8 months and overall survival (OS) of 5.4 months. The most common HER2 mutation was S310F. Co-occurring oncogenic alterations in TP53 and CDKN2A appeared to associate with worse outcome. The most frequently observed toxicity was diarrhea (56% any grade).
"Patients with biliary tract cancers have poor survival and a paradigm of treatment is precision medicine," said Dr. James J. Harding, MD Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College and an investigator of the trial. "In addition, HER2-mutant biliary cancers are uncommon and understudied. Results of the SUMMIT BTC cohort demonstrated that neratinib offers some respite for these underserved patients. However, additional studies are needed to determine if combining neratinib with other cancer therapies could significantly extend survival in patients and thereby improve their quality of life."
Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "Previous findings indicate that neratinib has a promising role as a treatment option for rare cancers. With the results from this cohort and others in the SUMMIT trial, we can continue to identify new groups of patients who can benefit from neratinib."