Puma Biotechnology announced that updated results from the cervical cancer cohort of SUMMIT, an ongoing Phase 2 basket trial examining the efficacy of neratinib in HER2-mutated cancers, were reported at the Society of Gynecologic Oncology 2019 Annual Meeting. The cervical cancer cohort was comprised of 11 patients with advanced and/or metastatic disease treated with neratinib monotherapy. Patients received a median of 2 prior regimens in the recurrent or metastatic setting before entering this trial. Six patients, or 54.5%, had been previously treated with bevacizumab prior to entering the study; 7 patients, or 63.6%, had received prior surgery; and 9 patients, or 81.8%, received prior radiation therapy. The objective response rate was 27.3%. The clinical benefit rate was 54.5% and included 3 patients with confirmed partial responses and 3 patients with stable disease that lasted greater than 16 weeks. The median progression free survival was 7.0 months. The safety profile observed in neratinib-treated cervical cancer patients in SUMMIT was consistent with that reported for HER2-amplified metastatic breast cancer. The most frequently observed adverse event was diarrhea, any grade including 1 grade 3 diarrhea event. The duration of grade 3 diarrhea was 1 day. None of the diarrhea events resulted in dose reduction, dose discontinuation or hospitalization, the company said. Alan Auerbach, CEO and President of Puma Biotechnology, said, “We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer. We look forward to the further development of neratinib in this patient population.”
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