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Puma Biotechnology Presents Updated Results from the Phase II SUMMIT Trial of Neratinib for HER2-Mutant, HR-Positive Metastatic Breast Cancer at SABCS 2020
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, presented updated results from the ongoing Phase II
About this update from Puma Biotechnology Inc
[{"type":"text","content":" LOS ANGELES--(BUSINESS WIRE)--\nPuma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, presented updated results from the ongoing Phase II SUMMIT trial of neratinib at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place. The presentation entitled, “Latest findings from the breast cancer cohort in SUMMIT – a phase 2 ‘basket’ trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, hormone receptor-positive, metastatic breast cancer,” is being presented at a Spotlight Poster Discussion Session by Komal Jhaveri, M.D., FACP, Memorial Sloan Kettering Cancer Center, an investigator of the trial. A copy of this poster presentation is available on the Puma website.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201209005093/en/\nThe Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 (ERBB2) or lung cancers with EGFR exon 18 mutations (NCT01953926). In the HER2-mutant, hormone receptor (HR)-positive breast cancer cohort, 51 patients received 240 mg of neratinib daily in combination with trastuzumab and fulvestrant. In this cohort, patients had received a median of 4 prior lines of therapy in the metastatic setting (range 1-10 prior regimens) before entering the trial. 36 patients (70.6%) had received prior fulvestrant, 35 patients (68.6%) had received prior aromatase inhibitor and 4 patients (7.8%) had received prior tamoxifen. Further, 30 patients (58.8%) received prior cyclin-dependent kinase 4/6-inhibitor (CDK4/6i) therapy. Thirty-five patients (68.6%) had received prior chemotherapy.\n\nThe interim efficacy summary of the breast cohort that received neratinib in combination with trastuzumab and fulvestrant showed that for the 37 RECIST efficacy evaluable patients, 17 patients (45.9%) experienced a confirmed objective response, including one complete response (2.7%) and 16 (43.2%) partial responses, and 20 patients (54.1%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 24 weeks). The median duration of response was 10.9 months and the median progression-free survival was...