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Puma Biotechnology Announces Publication of Results from Phase II SUMMIT Trial Evaluating Neratinib in HER2-Mutant, Metastatic Cervical Cancers
Data published online in Gynecologic Oncology LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced
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[{"type":"text","content":"\nData published online in Gynecologic Oncology\n\n LOS ANGELES--(BUSINESS WIRE)--\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that data from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the safety and efficacy of neratinib in HER2-mutated cancers, were published in the journal Gynecologic Oncology. The paper, “Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial,” appears in the July 25, 2020 online issue at https://www.gynecologiconcology-online.net/article/S0090-8258(20)33660-X/pdf and will be published in a future print issue of the journal.\n\n\nThe Phase II SUMMIT ‘basket’ trial is an open-label, international multi-histology study to evaluate the safety and efficacy of neratinib, administered daily to patients, across a broad spectrum of cancer types in patients whose tumors harbor activating HER2 somatic mutations. The primary endpoint was confirmed objective response rate. Secondary endpoints included response duration, clinical benefit rate, progression-free survival, overall survival, and safety.\n\n\nSixteen patients with HER2-mutant, persistent, metastatic or recurrent cervical cancer with disease progression after platinum-based treatment for advanced or recurrent disease were enrolled in the cohort and received oral neratinib daily with mandatory loperamide prophylaxis during the first cycle.\n\n\nThree of 12 RECIST-measurable patients had confirmed partial responses (overall response rate of 25%; 95% CI 5.5–57.2%); three had stable disease more than 16 weeks (clinical benefit rate of 50%; 95% CI 21.1–78.9%). Response duration for responders were 5.6, 5.9, and 12.3 months. Median progression-free survival was 7.0 months (95% CI 1.0–18.3 months) and the median overall survival was 16.8 months (95% CI 4.1–months not evaluable).\n\n\nThe safety profile observed in neratinib-treated cervical cancer patients in SUMMIT was consistent with that reported for HER2-positive metastatic breast cancer. Diarrhea (75%), nausea (44%), and decreased appetite (38%) were the most common of all grade adverse events. One patient (6%) reported grade 3 diarrhea. The rate of grade 3 diarrhea was considerably lower than reported for metastatic breast cancer patients. While this is a limited dataset, more re...