Puma Biotechnology has added more cervical-cancer patients to its Phase 2 trial of PB272 (neratinib), a therapy that can be used alone or with other therapies to treat patients with solid tumors and an activating HER2 mutation.
The company made the decision after preliminary data indicated that the therapy helped those with cervical cancer. The fourth cohort of the SUMMIT trial includes 18 more patients with HER2-mutant cervical cancer.
“We are pleased to expand our evaluation of neratinib in metastatic cervical cancer, an orphan and deadly disease with few treatment options,” Dr. David Hyman, director of developmental therapeutics at Memorial Sloan Kettering Cancer Center, and principal investigator of the trial, said in a news release. “We believe this once again demonstrates the value of the basket study approach, in particular for developing targeted therapy for rare diseases with clinically actionable mutations. We look forward to presenting the full results of the SUMMIT trial at a medical meeting in 2017.”
The open-label, multicenter, international study (NCT01953926) was designed to assess the safety and effectiveness of daily doses of PB272 in patients with solid tumors and the activating mutations EGFR, HER2, or HER3.
The trial included patients with hormone-receptor-negative breast cancer, endometrial cancer, ovarian cancer, biliary-tract cancer, gastric and esophageal cancer, and all other solid tumors with HER2 mutations.
Most of the patients received PB272 by itself. Those with hormone-receptor-positive breast cancer received PB272 plus Faslodex (fulvestrant), and those with bladder cancer received PB272 and Taxol (paclitaxel).
Initially, cervical-cancer patients were part of a cohort of patients with “other solid tumors with an HER2 mutation.”
The company decided to create a cohort of only HER2-mutant cervical-cancer patients to better assess PB272’s impact on that population.
“We are pleased to expand the fourth cohort in the basket trial,” said Alan H. Auerbach, Puma’s president and chief executive officer. “Although it is early, we are pleased with the initial activity that we are seeing in the patients with HER2 mutated cervical cancer in the trial. We look forward to continuing enrollment into this expanded cohort and look forward to presenting the full results from the SUMMIT study in 2017.”