Puma Biotechnology Presents Interim Results from the Biliary Tract Cancers Cohort of the Phase II SUMMIT “Basket” Trial of Neratinib at ASCO GI
January 15, 2021 at 08:03 am EST
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Puma Biotechnology, Inc. announced 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 GI) that is currently taking place. The presentation, entitled, “Targeting HER2 (ERBB2) mutation-positive advanced biliary tract cancers with neratinib. 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.
Puma Biotechnology, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of products to enhance cancer care. The Company's lead product is NERLYNX, an oral version of neratinib, for the treatment of HER2-positive breast cancer. Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4 It also engaged in the development and commercialization of, alisertib. Alisertib is a selective, small molecule inhibitor of aurora kinase A that is designed to disrupt mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Its neratinib has clinical application in the treatment of several other cancers as well, including other tumor types that over-express or have a mutation in HER2 or epidermal growth factor receptor (EGFR), such as breast cancer, cervical cancer, lung cancer, or other solid tumors.
PUMA BIOTECHNOLOGY, INC. 
