Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib

Puma Biotechnology, Inc., a biopharmaceutical company, announced that updated results from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, were reported at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting in Honolulu, Hawaii. “Neratinib in patients with HER2-mutant, metastatic cervical cancer: findings from the phase II SUMMIT ‘basket’ trial,” was presented during the Scientific Plenary Session by Anishka D’Souza, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine of University of Southern California (USC). SGO selected this abstract as the recipient of the 2019 SGO Presidential Award. Slides from the presentation are available on the Puma Biotechnology website. The 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, somatic HER2 mutations. 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 (range 1–4) prior regimens in the recurrent or metastatic setting before entering this trial. Six patients (54.5 percent) had been previously treated with bevacizumab prior to entering the study; 7 patients (63.6 percent) had received prior surgery; and 9 patients (81.8 percent) received prior radiation therapy. The objective response rate was 27.3 percent (95 percent CI: 6.0 percent–61.0 percent). The clinical benefit rate was 54.5 percent (95 percent CI: 23.4 percent–83.3 percent) 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 (95 percent CI: 0.7–20.1 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 (n=9, 81.8 percent) including 1 (9 percent) 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.

“Somatic HER2 mutations represent a distinct class of oncogenic driver mutations that appear to be clinically actionable for metastatic cervical cancers. Treatment with neratinib led to durable responses and disease control in metastatic patients with HER2-mutant cervical cancer,” said Dr. D’Souza, who practices oncology at the USC Norris Comprehensive Cancer Center. Alan H. Auerbach, CEO and President of Puma Biotechnology, added, “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.” – Medical Buyer Bureau