Puma Biotechnology presents Phase II results of neratinib in breast cancer
Puma Biotechnology announced that results from an ongoing Phase II clinical trial of Puma's drug neratinib are being presented at the 2019 San Antonio Breast Cancer Symposium. Neratinib was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the U.S. as Nerlynx tablets. Nerlynx was granted marketing authorization by the European Commission for the extended adjuvant treatment of hormone receptor-positive HER2-positive early stage breast cancer in August 2018. The Phase II SUMMIT basket trial is a study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 or HER3 mutations. The interim efficacy summary of the breast cohort that received neratinib in combination with trastuzumab and fulvestrant showed that for the 17 efficacy evaluable patients, 9 patients - 53% - experienced a confirmed objective response, all of which were classified as partial responses, and 10 patients - 59% - experienced clinical benefit. The median duration of response has not been reached and the median progression-free survival was 9.8 months. At the time of data cut-off, five patients continued to receive treatment. The most frequently observed adverse event was diarrhea. No patient permanently discontinued neratinib due to diarrhea.