Phase 3 ROSELLA (GOG-3073, ENGOT-ov72) Trial of Relacorilant + Nab-paclitaxel vs Nab-paclitaxel in Platinum-resistant Ovarian Cancer: Primary Results and Outcomes in Older Patients

Summary

ROSELLA met its primary endpoint of improving PFS: Relacorilant, a first-in-class, oral, selective glucocorticoid receptor antagonist (SGRA), extended PFS by BICR (HR 0.70, log-rank test P=0.0076) compared to nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer
Median survival prolonged by 4.5 months: The addition of relacorilant to nab-paclitaxel showed a clinically meaningful improvement in overall survival at this interim analysis (HR 0.69, nominal log-rank test P=0.0121, median 16.0 vs 11.5 months)
Consistent benefit in older patients: The addition of relacorilant to nab-paclitaxel showed a benefit in patients ≥65 years, (PFS HR 0.61, nominal log-rank test P=0.0247; OS HR 0.55, nominal log-rank test P=0.0143)
Well-tolerated, favorable safety profile: Relacorilant plus nab-paclitaxel has a well-tolerated, favorable safety profile in the overall safety population and in the subgroup of patients ≥65 years