Niraparib-pembrolizumab shows encouraging activity in recurrent ovarian cancer

  • Konstantinopoulos PA, & et al.
  • JAMA Oncol
  • 13 Jun 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Niraparib in combination with pembrolizumab shows activity in patients with platinum-resistant and platinum-refractory recurrent ovarian carcinoma across all subgroups.
  • No new safety signal was reported.

Why this matters

  • Treatment options are limited for these patients.

 Study design

  • Phase 1/2 TOPACIO/Keynote-162 study of 62 women with platinum-resistant/refractory recurrent ovarian carcinoma who received niraparib+pembrolizumab.
  • Funding: TESARO.

Key results

  • Median follow-up duration was 12.4 months.
  • Patients had received a median of 3 previous lines of therapy.
  • Pooled overall response rate (ORR) was 18% and disease control rate was 65% (complete response, 5%; partial response, 13%; stable disease, 47%).
  • Median duration of response was not reached (range, 4.2 to ≥14.5 months).
  • The ORRs were consistent across subgroups based on:
    • platinum-based chemotherapy sensitivity (resistant, 21%; refractory, 13%; patients with ≥180 days platinum-free interval and unable to receive further platinum therapy, 20%);
    • number of prior lines (1-2, 28%; ≥3, 11%);
    • previous bevacizumab treatment (19%) and no previous bevacizumab (17%);
    • tumor BRCA (positive, 18%; negative, 19%); and
    • homologous recombination deficiency status (positive, 14%; negative, 19%).
  • Most common grade ≥3 treatment-related adverse events were anemia (21%) and thrombocytopenia (9%).

Limitations

  • Lack of control group.

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