Puma Biotechnology Announces Publication of Results from Phase Ii Summit ‘Basket’ Trial Evaluating Neratinib in Her2 and Her3 Mutant Cancers
January 31, 2018 at 01:16 pm
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Puma Biotechnology, Inc. announced that initial results from the company’s ongoing SUMMIT Phase II ‘basket’ clinical trial of PB272 (neratinib) in patients with tumors harboring HER2 or HER3 mutations were published in the journal Nature. The Phase II SUMMIT trial is a global, multi-histology, open-label, precision-medicine ‘basket’ study evaluating the safety and efficacy of neratinib administered daily to patients with a wide variety of solid tumors with activating HER2 or HER3 mutations. SUMMIT is designed to evaluate the contributions of both genetic mutation and cancer type on individual patients’ response to neratinib. Information generated from the trial will help guide neratinib-based targeted therapy across a broad spectrum of tumor types with HER2 or HER3 mutations, including patients with rare tumors who may not otherwise have access to investigational therapies.
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.