Key clinical point: Niraparib is tolerable and shows activity in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC) and DNA repair gene defects (DRD).
Major finding: The median follow-up duration was 10 months and 8.6 months in the measurable BRCA and non- BRCA cohorts, respectively. The objective response rate was 34.2% in the measurable BRCA cohort and 10.6% in the measurable non- BRCA cohort. The most common grade 3 or higher adverse events were hematological (anemia, thrombocytopenia, and neutropenia). These adverse events were manageable with treatment interruptions, dose reductions, or supportive measures.
Study details: An open-label, single-arm, phase 2 GALAHAD study of 289 patients with histologically confirmed mCRPC and DRD who were treated with niraparib.
Disclosures: This study was sponsored by Janssen Research & Development. The authors received grants, contracts, payments, honoraria, travel support, and consulting/advisory/personal fees or reported being in a leadership role, holding stocks, or other ownership roles relative to Janssen Research & Development.
Source: Smith MR et al. Lancet Oncol. 2022 (Feb 4). Doi: 10.1016/S1470-2045(21)00757-9.