On July 3, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported updated interim results from the biliary cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer 2019, currently taking place in Barcelona, Spain (Press release, Puma Biotechnology, JUL 3, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-presents-interim-results-biliary-tract-cohort-its-phase-ii-summit-b [SID1234537375]). "Treating HER2-mutant Biliary Tract Cancer with Neratinib: Benefits of HER2-directed Targeted Therapy in the Phase 2 SUMMIT ‘Basket’ Trial" was an oral presentation by James J. Harding, MD, Assistant Attending, Gastrointestinal Oncology and Early Drug Development Service, Memorial Sloan Kettering Cancer Center on July 3rd at 6:10 p.m. CEST. In addition, a poster presentation summarizing the trial results will be presented on July 4 beginning at 11:05 a.m. CEST. The slides and poster presentation will be available on the Puma website.
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The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, somatic HER2 mutations. The biliary cancer cohort comprised 20 patients with advanced and/or metastatic disease treated with neratinib monotherapy. More specifically, 9 patients had cholangiocarcinoma, 9 had gallbladder cancer and 2 had cancer of the Ampulla of Vater. Patients received a median of 2 (range 0-7) prior systemic regimens before entering this trial. Most patients had received a gemcitabine-based regimen (n=18, 90%), 11 patients (55%) had undergone prior surgery, and 4 patients (20%) received prior radiation therapy. The confirmed objective response rate was 10% (95% CI: 1.2–31.7). The clinical benefit rate was 30% (95% CI: 11.9–54.3) and included 2 patients with confirmed partial responses and 4 patients with stable disease that lasted ≥ 16 weeks. The median progression-free survival was 1.8 months (95% CI: 0.9–3.7).
The safety profile observed in the neratinib-treated biliary tract cancer cohort is consistent with that previously reported for all HER2-mutated cancer patients in the SUMMIT trial. The most frequently observed adverse event was diarrhea, any grade (n=10, 50%) including 4 (20%) patients with grade 3 diarrhea. None of the diarrhea events resulted in dose discontinuation within the biliary tract cancer cohort; 2 patients reduced study drug due to diarrhea events.
"Somatic HER2 mutations represent a distinct class of oncogenic driver mutations that appear to be clinically actionable for a subset of metastatic biliary tract cancers. A subset of cholangiocarcinoma and gallbladder cancer patients had tumor shrinkage or extended disease control suggesting anti-tumor activity in this rare population. These early findings in targeting HER2 in advanced bile duct cancers warrant further clinical and translational investigation." said Dr. Harding.
Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased with the initial activity seen with neratinib in this cohort of patients with biliary tract cancer. We look forward to the further enrollment of patients in the SUMMIT trial and further development of neratinib in this HER2-mutated patient population."