Combined Niraparib and Pembrolizumab for Advanced Triple-Negative Breast Cancer
Posted: Monday, July 23, 2018
The PARP inhibitor niraparib and the immune checkpoint inhibitor pembrolizumab in combination may prove effective for treating advanced triple-negative breast cancer, particularly BRCA-mutant disease, according to the phase I/II TOPACIO/KEYNOTE-162 clinical trial. The research, which was presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 1011) by Shaveta Vinayak, MD, MS, of Case Western Reserve University, Cleveland, and colleagues, flagged no new safety signals.
The study included 54 patients with triple-negative breast cancer, whose median age was 54 years. Patients had received a median of one prior line of therapy in the metastatic setting. The primary endpoint was objective response rate, with disease control rate as a secondary endpoint.
The objective response rate among the 45 evaluable patients was 29%, and the disease control rate was 49%. In the 12 patients with tumor BRCA-mutant disease, the outcomes were better, with an objective response rate of 67% and a disease control rate of 75%. The median progression-free survival was 8 months in BRCA-mutant patients. Outcomes were also better in PD-L1–positive patients, who had an objective response rate of 33% compared with 15% in PD-L1–negative patients.
The most common adverse events of grade 3 or higher were thrombocytopenia (13%) and anemia (11%), and 50% of all patients had at least 1 adverse event of grade 3 or higher. A total of 11 patients remain on treatment.
