Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Niraparib-Pembrolizumab Combo Finds Niche in Breast, Ovarian Cancers

Key clinical point: The combination of niraparib and pembrolizumab is active in patients with advanced/metastatic TNBC and patients with recurrent platinum-resistant ovarian cancer.

Major finding: The objective response rate was 21% among patients with TNBC and 18% among patients with ovarian cancer.

Study details: Open-label, single-arm, phase 1/2 trial among patients with advanced or metastatic TNBC (n = 55) or recurrent platinum-resistant ovarian carcinoma (n = 62) enrolled irrespective of BRCA mutation status or PD-L1 expression (TOPACIO/KEYNOTE-162 trial).

Disclosures: Dr. Vinayak disclosed receiving clinical trial funding from TESARO; serving on an advisory board for TESARO; and serving on an advisory board for OncoSec Medical (uncompensated). Dr. Konstantinopoulos disclosed serving on advisory boards for AstraZeneca, Pfizer, and Merck. The trial was supported by TESARO: a GSK company and Merck, and in part by Stand Up to Cancer (a program of the Entertainment Industry Foundation); the Ovarian Cancer Research Fund Alliance; and National Ovarian Cancer Coalition Dream Team Translational Research.


Vinayak A et al. JAMA Oncol. 2019 June 13. doi: 10.1001/jamaoncol.2019.1029. Konstantinopoulos PA et al. JAMA Oncol. 2019 June 13. doi: 10.1001/jamaoncol.2019.1048.