(Breast Cancer) Is Niraparib Plus Pembrolizumab Effective for BRCA Mutation?
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TOPACIO/KEYNOTE-162: Niraparib Plus Pembrolizumab in Triple-Negative Breast Cancer
- July 10, 2019
- Reading time: 2 minutes
On June 13, 2019, the medical journal JAMA Oncology published Phase 2 results from the TOPACIO/KEYNOTE-162 Phase 1/2 trial: "Concurrent use of PARP inhibitor niraparib plus anti-PD-1 antibody pembrolizumab in patients with metastatic triple-negative breast cancer."
Trial Design
The TOPACIO/KEYNOTE-162 trial was an open-label, single-arm Phase 1/2 trial administering niraparib 200 mg once daily plus pembrolizumab 200 mg every 3 weeks to patients with metastatic triple-negative breast cancer. Primary endpoint: ORR. Secondary endpoints: duration of response, disease control rate.
Background: The combination of niraparib plus pembrolizumab enhanced antitumor activity in preclinical models, independent of BRCA mutation or PD-L1 expression status, providing the rationale for this trial.
Efficacy Results
Overall evaluable population:
- ORR: 21%
- Disease control rate: 49%
- Median duration of response: Not reached
By BRCA status:
- BRCA-positive: ORR 47%, response rate ≥6 months: 80%, median PFS: 8.3 months
- BRCA-negative: ORR 11%, response rate ≥6 months: 33%, median PFS: 2.1 months
Safety Profile
Most common adverse events: anemia (18%), fatigue (7%), immune-related adverse events (15%). No new adverse events were identified in this trial.
Conclusions
Based on TOPACIO/KEYNOTE-162 results, Shaveta Vinayak concluded that the combination of PARP inhibitor niraparib plus anti-PD-1 antibody pembrolizumab demonstrated promising antitumor activity in metastatic triple-negative breast cancer, particularly showing a higher ORR in BRCA-positive patients.
Source: Open-Label Clinical Trial of Niraparib Combined With Pembrolizumab for Treatment of Advanced or Metastatic Triple-Negative Breast Cancer. JAMA Oncol. 2019 Jun 13.
Tags: #BreastCancer #TripleNegativeBreastCancer
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