Background
Phase III, N=381 (relacorilant n=188, nab-paclitaxel alone n=193), platinum-resistant recurrent ovarian cancer, 1-3 prior therapy lines, median follow-up 24.8 months
Interventions and follow up
Arm A: Relacorilant (150 mg daily on days before, of, and after chemo) + nab-paclitaxel (80 mg/m² days 1,8,15 q28d)
Arm B: Nab-paclitaxel alone (100 mg/m² days 1,8,15 q28d)
Primary endpoint: Overall survival (dual primary with PFS)
mFollow up: Median 24.8 months [95% CI 23.6-25.7]
Arm B: Nab-paclitaxel alone (100 mg/m² days 1,8,15 q28d)
Primary endpoint: Overall survival (dual primary with PFS)
mFollow up: Median 24.8 months [95% CI 23.6-25.7]
Results
Overall survival: HR 0.65 [95% CI 0.51-0.83], P=.0004 (statistically and clinically significant). Median OS 16.0 months (relacorilant) vs 11.9 months (monotherapy), 4.1-month extension. 18-month OS: 46% vs 27%
PFS: Also significantly improved (prior primary analysis)
PFS: Also significantly improved (prior primary analysis)
Adverse events
Main adverse events: Neutropenia 64%, anemia 61%, fatigue 54%, nausea 44% in combination group. Similar AE burden when adjusted for treatment duration. No new safety signals vs primary analysis.
Conclusions
Relacorilant plus nab-paclitaxel significantly improves OS in platinum-resistant ovarian cancer without need for biomarker selection. Median OS gain of 4.1 months with manageable toxicity supports new standard for this difficult-to-treat population.
Key Limitations
Key Limitations: Modest OS gain (4.1 months) may be clinically marginal for some patients. No biomarker-driven selection limits precision; patient heterogeneity high. All patients previously exposed to bevacizumab and 61% to PARP inhibitors.
Clinical Context
ROSELLA establishes glucocorticoid receptor antagonism as viable mechanism in ovarian cancer; complements standard triplet approaches. FDA approval anticipated; represents new option for platinum-resistant disease with 3+ prior lines.
References
References: Lorusso D et al, Lancet, 2026