Niraparib (PARP inhibitor) Delivers 4.4-mo mPFS in DDR-Altered Advanced Pancreatic Cancer (NIRA-PANC)

Niraparib is an oral PARP1/2 inhibitor tested as monotherapy in an open-label, single-arm Phase II study (NIRA-PANC; NCT03553004) for metastatic or unresectable pancreatic cancer with germline or somatic DDR alterations (n=37; 29 efficacy-evaluable) after ≥1 prior line. The primary endpoint 6-month PFS rate was 41.38% (12/29); median PFS was 4.4 months and median OS was 10.3 months, with a signal enrichment in germline BRCA1/2 (n=14; 6-month PFS 50%, mOS 12.1 months) versus non-BRCA DDR alterations (n=15; 6-month PFS 33.33%, mOS 10.3 months). Safety was consistent with PARP inhibition: AEs occurred in 78% (most common anemia 27%) with no treatment-related deaths; efficacy looks in the ballpark of typical post-gemcitabine options like nal-IRI+5-FU/LV (NAPOLI-1 mOS ~6.1 months) but cross-trial comparisons are limited, and this trial’s biomarker-enriched population may be more chemo-sensitive than unselected PDAC.