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Comment & Response
December 26, 2019

BRCA Mutations and Homologous Recombination Repair Deficiency in Treatment With Niraparib Combined With Pembrolizumab

Author Affiliations
  • 1Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
JAMA Oncol. 2020;6(3):440-441. doi:10.1001/jamaoncol.2019.4595

To the Editor We have read the recently published studies by Vinayak et al1 and Konstantinopoulos et al2 investigating the regimen of niraparib plus pembrolizumab in patients with triple-negative breast cancer (TNBC) or ovarian cancer with great interest. Results of this preliminary trial, the TOPACIO/KEYNOTE-162 (Niraparib in Combination With Pembrolizumab in Patients With Triple-Negative Breast Cancer or Ovarian Cancer) trial, demonstrate a tolerable safety profile and promising effectiveness of niraparib combined with pembrolizumab for treatment of refractory TNBC1 or platinum-resistant ovarian cancer.2 Although the findings are appealing, we believe that the results of biomarker analysis on the mutation status of BRCA or homologous recombination repair (HRR) must be interpreted with caution. According to the published data,1,2 the objective response rate (ORR) for patients with platinum-resistant ovarian cancer was not associated with tumor BRCA (tBRCA) mutation or HRR deficiency. In patients with TNBC, intriguingly, those with tBRCA mutation had higher ORR, higher disease control rate, and longer progression-free survival than those without confirmed tBRCA mutation. Herein, we propose 3 aspects that should be highlighted in analyzing the predictive role of BRCA mutations and HRR deficiency and need to be emphasized in future phase 3 clinical investigations.

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