{"id":44704,"date":"2022-06-04T16:01:20","date_gmt":"2022-06-04T14:01:20","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/puma-biotechnology-presents-final-results-from-the-biliary-tract-cohort-of-the-phase-2-summit-basket-trial-of-neratinib-at-the-asco-2022-annual-meeting\/"},"modified":"2022-06-04T16:01:20","modified_gmt":"2022-06-04T14:01:20","slug":"puma-biotechnology-presents-final-results-from-the-biliary-tract-cohort-of-the-phase-2-summit-basket-trial-of-neratinib-at-the-asco-2022-annual-meeting","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/puma-biotechnology-presents-final-results-from-the-biliary-tract-cohort-of-the-phase-2-summit-basket-trial-of-neratinib-at-the-asco-2022-annual-meeting\/","title":{"rendered":"Puma Biotechnology Presents Final Results from the Biliary Tract Cohort of the Phase 2 SUMMIT \u2018Basket\u2019 Trial of Neratinib at the ASCO 2022 Annual Meeting"},"content":{"rendered":"
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LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented final results from the Phase II SUMMIT \u2018basket\u2019 trial, assessing the efficacy of neratinib in treatment-refractory patients with metastatic biliary tract cancers with somatic HER2 <\/i>mutations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation entitled \u201cTargeting HER2 <\/i>mutation-positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT \u2018basket\u2019 trial\u201d was presented at the Gastrointestinal Cancer \u2013 Gastroesophageal, Pancreatic, and Hepatobiliary Poster Session (#4079) by James J. Harding, MD, Regional Director, Early Drug Development, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, an investigator of the trial. A copy of this poster presentation is available on the Puma website.\n<\/p>\n

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\nNeratinib is an irreversible, pan-HER, oral tyrosine kinase inhibitor. The Phase II SUMMIT trial is an open-label, single-arm, multi-cohort, \u2018basket\u2019 trial of neratinib in patients with solid tumors that harbor oncogenic somatic HER2<\/i> mutations. The study included a cohort of treatment-refractory patients with metastatic biliary tract cancers (BTCs). While HER2 overexpression is associated with an increased risk of disease recurrence in patients with resected BTC, there is limited data on targeting HER2 <\/i>mutations <\/i>in these patients.\n<\/p>\n

\nEfficacy results from the BTC cohort of 25 patients (11 cholangiocarcinoma, 10 gallbladder, 4 ampullary cancers) demonstrated an overall response rate (ORR) of 16%, 95% CI 4.5-36.1%), median progression free survival (PFS) of 2.8 months and overall survival (OS) of 5.4 months. The most common HER2 <\/i>mutation was S310F. Co-occurring oncogenic alterations in TP53<\/i> and CDKN2A<\/i> appeared to associate with worse outcome. The most frequently observed toxicity was diarrhea (56% any grade).\n<\/p>\n

\n\u201cPatients with biliary tract cancers have poor survival and a paradigm of treatment is precision medicine,\u201d said Dr. James J. Harding, MD Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College and an investigator of the trial. \u201cIn addition, HER2<\/i>-mutant biliary cancers are uncommon and understudied. Results of the SUMMIT BTC cohort demonstrated that neratinib offers some respite for these underserved patients. However, additional studies are needed to determine if combining neratinib with other cancer therapies could significantly extend survival in patients and thereby improve their quality of life.\u201d\n<\/p>\n

\nAlan H. Auerbach, Chief Executive Officer and President of Puma, added, \u201cPrevious findings indicate that neratinib has a promising role as a treatment option for rare cancers. With the results from this cohort and others in the SUMMIT trial, we can continue to identify new groups of patients who can benefit from neratinib.\u201d\n<\/p>\n

\nAbout Puma Biotechnology<\/b>\n<\/p>\n

\nPuma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed\/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX\u00ae (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed\/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.\n<\/p>\n

\nFurther information about Puma Biotechnology may be found at https:\/\/www.pumabiotechnology.com<\/a>.\n<\/p>\n

\nImportant Safety Information Regarding NERLYNX\u00ae (neratinib) U.S. Indication<\/b>\n<\/p>\n

\nNERLYNX\u00ae (neratinib) tablets, for oral use<\/b>\n<\/p>\n

\nINDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:<\/b>\n<\/p>\n