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

Trial ID # NCT02470585; VELIA
Phase III
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Veliparib
Alternate Drug Names ABT-888
Drugs in Trial Carboplatin, Paclitaxel, Veliparib
Eligible Participant

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

Patients Enrolled

1140

Therapy Setting

First-line

Study Design

Double Blind, Randomized

Endpoints

PFS, evaluated per RECIST

Efficacy

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-pos (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-neg:
PFS: 15.0 vs 12.9 vs 11.5 months, HR: 0.81 (0.60-1.09)

Clinically Significant Adverse Events

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%)

Conclusion

Veliparib added to chemotherapy and continued as maintenance significantly extended PFS in all newly diagnosed patients

Reference

Coleman RF et al. Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer. N Engl J Med (2019) Sep 28
https://www.ncbi.nlm.nih.gov/pubmed/31562800