On January 15, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported interim results from the biliary tract cancers cohort of the ongoing SUMMIT trial of neratinib at the virtual 2021 Gastrointestinal Cancers Symposium hosted by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO GI) that is currently taking place (Press release, Puma Biotechnology, JAN 15, 2021, View Source [SID1234574061]). The presentation, entitled, "Targeting HER2 (ERBB2) mutation-positive advanced biliary tract cancers with neratinib: Results from the phase II SUMMIT "basket" trial," is being presented at a Poster Session by James J. Harding, MD, Regional Director, Early Drug Development, Memorial Sloan Kettering Cancer Center, an investigator of the trial. A copy of this poster presentation is available on the Puma website.
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The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that included a cohort evaluating the safety and efficacy of neratinib administered daily to patients who have HER2 (ERBB2) mutation-positive advanced biliary cancer. Patients received 240 mg of neratinib daily as a single agent.
In this cohort of 25 patients, 11 patients had cholangiocarcinoma, 10 patients had cancer of the gallbladder and 4 patients had cancer of the ampulla of Vater. 24 patients had received prior systemic chemotherapy with a median of 2 prior lines of therapy (range 0-7) before entering the trial.
The efficacy results from the trial demonstrated that there were 4 patients with confirmed partial responses (3 patients with cancer of the gallbladder and 1 patient with cholangiocarcinoma) and an additional 3 patients who had stable disease lasting ≥16 weeks (1 patient with cancer of the ampulla of Vater and 2 patients with cholangiocarcinoma, one of which remained on treatment for 56 weeks before progression). 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.
The safety profile of patients with biliary tract tumors is similar to that previously reported for patients treated with neratinib monotherapy and mandatory loperamide prophylaxis in the first 2 months; treatment was manageable, with 56% of patients experiencing some diarrhea, including 24% with grade 3 diarrhea. There were no episodes of grade 4 diarrhea, and no treatment discontinuations due to diarrhea. Four patients required neratinib dose reduction and one patient was hospitalized due to diarrhea.
"We have shown neratinib to be safe and tolerable in these patients with advanced biliary tract tumors, and demonstrated activity comparable to current standards of care with similar progression-free survival and overall survival in these heavily pretreated patients," said Dr. Harding.
Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased with the preliminary activity seen with neratinib in this cohort of patients and specifically in patients with cancer of the gallbladder and cholangiocarcinoma."