Activity of Niraparib Plus Pembrolizumab in Recurrent Ovarian Carcinoma


Key Points

  • Objective response was observed in 18% of patients, with disease control in 65%.
  • Responses were observed across patient subgroups.

In a pooled analysis of the phase I/II TOPACIO/KEYNOTE-162 study reported in JAMA Oncology, Konstantinopoulos et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with recurrent ovarian carcinoma.

Study Details

The analysis included 60 evaluable women from multiple U.S. sites treated with niraparib 200 mg once daily and pembrolizumab 200 mg on day 1 of each 21-day cycle. Patients had received a median of three prior lines of therapy.

Response Rates

Among the 60 evaluable patients, objective response was observed in 11 (18%), with complete response in 3 patients; the disease control rate was 65%. Median duration of response was not reached (range = 4.2 to ≥14.5 months).

Objective response rates were:

  • 21% in 29 patients with platinum-resistant disease and 13% in 16 with platinum-refractory disease
  • 19% and 17% in 37 patients with and 23 without prior treatment with bevacizumab, respectively
  • 18% and 19% in 11 patients with mutant BRCA and 47 with wild-type BRCA, respectively
  • 21% and 10% in 33 patients with positive and 21 with negative programmed cell death ligand-1 status, respectively
  • 14% and 19% in 21 patients with positive and 32 with negative homologous recombination deficiency status, respectively
  • 28% vs 11% in 25 patients with one or two vs 35 with ≥ three prior lines of therapy, respectively.   

Adverse Events

The most common treatment-related adverse events of grade ≥ 3 were anemia (21%) and thrombocytopenia (9%). Immune-related adverse events occurred in 14 patients (26%) and were grade 3 in 4 (8%), with the most common grade 3 event being hyperglycemia in 2 patients (4%).

The investigators concluded, “Niraparib in combination with pembrolizumab is tolerable, with promising antitumor activity for patients with ovarian carcinoma who have limited treatment options regardless of platinum status, biomarker status, or prior treatment with bevacizumab. Responses in patients without tumor BRCA mutations or nonhomologous recombination deficiency cancers were higher than expected with either agent as monotherapy.”

Panagiotis A. Konstantinopoulos, MD, PhD, of the Division of Gynecologic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, is the corresponding author for the JAMA Oncology article.

Disclosure: The study was supported by TESARO: A GSK Company, Merck & Co, and others. For full disclosures of the study authors, visit

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