A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

1140

First-line

Double Blind, Randomized

PFS, evaluated per RECIST

CarboPt+Pac+Vel w/Vel maint vs CarboPt+Pac+Vel vs CarboPt+Pac:

All patients:
PFS: 23.5 vs 15.2 vs 17.3 months, HR: 0.68 (0.56-0.83, p<0.001), 1.07 (0.90-1.29)
BRCA MUT:
PFS: 34.7 vs 21.1 vs 22.0 months, HR: 0.44 (0.28-0.68, p<0.001), 1.22 (0.82-1.80)
HRD+ (incl. BRCA MUT):
PFS: 31.9 vs 18.1 vs 20.5 months, HR: 0.57 (0.43-0.76, p<0.001), 1.10 (0.86-1.41)

Exploratory analyses:
BRCA WT:
PFS: 18.2 vs 14.5 vs 15.1 months, HR: 0.80 (0.64-1.00)
HRD-:
PFS: 15.0 vs 12.9 vs 11.5 months, HR: 0.81 (0.60-1.09)

CarboPt+Pac+Vel w/Vel maint vs CarboPt+Pac+Vel vs CarboPt+Pac:
Serious AE: 1 AML vs 1 MDS vs none
Grade 3-4 AE: any (77 vs 88 vs 88%), neutropenia (49 vs 62 vs 58%), anemia (26 vs 41 vs 38%), thrombocytopenia (8 vs 31 vs 28%), leukopenia (9 vs 12 vs 18%)

Veliparib added to chemotherapy and continued as maintenance significantly extends PFS in all newly diagnosed patients, but shows most benefit in BRCA MUT patients

Coleman RF et al. Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer. N Engl J Med (2019) 381(25):2403-2415
https://www.ncbi.nlm.nih.gov/pubmed/31562800