ROSELLA: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Patients with Platinum-Resistant Ovarian Cancer

Summary

Relacorilant is a novel SGRA: Relacorilant is an oral, selective glucocorticoid receptor antagonist (SGRA) in development for the treatment of patients with cancer
ROSELLA met its primary endpoint: The addition of relacorilant to nab-paclitaxel extended progression-free survival assessed by BICR with a statistically and clinically significant hazard ratio (HR) of 0.70 (median 6.5 vs 5.5 months, P=0.0076) in the phase 3 ROSELLA study in patients with platinum-resistant ovarian cancer
- Median survival prolonged by 4.5 months: At this interim overall survival analysis, the addition of relacorilant to nab-paclitaxel showed a clinically meaningful improvement in overall survival (HR 0.69, median 16.0 vs 11.5 months, P=0.0121)
- Well-tolerated, favorable safety profile: Relacorilant plus nab-paclitaxel was well-tolerated, with a favorable safety profile that was comparable between treatment arms when adjusted for nab-paclitaxel exposure. The safety profile was consistent with previously reported data; no new safety signals were identified

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