GSK’s Zejula Fails to Meet Overall Survival Goal in First-Line Ovarian Cancer, Combination Therapy Disappoints

Restriction on Second-Line Indication:
The FDA requested GSK to restrict the second-line maintenance indication for Zejula (niraparib) to only patients with recurrent ovarian cancer whose tumors harbor deleterious or suspected deleterious germline BRCA mutations.

First-Line Indication Unchanged:
The first-line indication for Zejula remains unchanged for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.

NOVA Trial Results: The final overall survival (OS) analysis of the ENGOT-OV16/NOVA phase III trial showed a hazard ratio (HR) of 1.06 (95% CI:
0.81-1.37) in the non-germline BRCA-mutated cohort, leading to the restriction.

Efficacy in BRCA-Mutated Cohort:
Zejula demonstrated a statistically significant improvement in progression-free survival (PFS) in both the germline BRCA-mutated and non-germline BRCA-mutated cohorts in the NOVA trial.

Ongoing Development:
GSK continues to evaluate niraparib in various clinical trials, including combination studies for first-line ovarian cancer maintenance and advanced non-small cell lung cancer.