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