Phase 3 Results of Relacorilant + Nab-Paclitaxel v Nab-Paclitaxel In Platinum-Resistant Ovarian Cancer (ROSELLA): Secondary Endpoints
Summary
- ROSELLA met its primary endpoint of improving PFS: Relacorilant, an oral, selective glucocorticoid receptor antagonist in development for the treatment of patients with cancer, in combination with nab-paclitaxel extended progression-free survival by BICR (log-rank test P=0.0076, HR 0.70) compared to nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer, in a population including patients who progressed within 1–3 months after their primary platinum regimen.
- 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 (nominal log-rank test P=0.0121, HR 0.69, median 16.0 vs 11.5 months).
- 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 duration of exposure. The safety profile was consistent with previously reported data; no new signals were identified.
- Consistent benefit in poor prognosis groups: The addition of relacorilant to nab-paclitaxel shows a benefit in poor prognosis sub-groups, including those with a primary platinum-free interval of 1-6 months, and primary platinum-refractory disease (PFS nominal log-rank test P=0.0081, HR 0.50, OS nominal log-rank test P=0.0140, HR 0.52).