Research Summary

Phase 3 ROSELLA Shows OS Gain in Platinum-Resistant Ovarian Cancer

Edited by:
Ashton L. Stahl

Key Highlights

  • Relacorilant plus nab-paclitaxel significantly improved overall survival vs nab-paclitaxel alone in platinum-resistant ovarian cancer.
  • Median overall survival was 16 months with the combination vs 11.9 months with monotherapy; 18-month overall survival was 46% vs 27%.
  • The phase 3 ROSELLA trial also showed improved second progression-free survival, with similar subsequent anticancer treatment patterns between groups.
  • No new safety signals emerged with longer follow-up, although grade 3 or worse neutropenia, anemia, and fatigue were numerically more frequent in the combination group.

In patients with platinum-resistant ovarian cancer, adding relacorilant to nab-paclitaxel significantly extended overall survival compared with nab-paclitaxel alone in the phase 3 ROSELLA trial published in The Lancet. Investigators reported a hazard ratio for death of 0.65 (95% CI, 0.51-0.83; P = .0004), with a 4.1-month improvement in median overall survival.  

ROSELLA was an open-label, randomized, controlled phase 3 trial conducted at 117 sites in 14 countries. Women aged 18 years or older with platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer were eligible if they had received 1 to 3 prior lines of systemic anticancer therapy, prior bevacizumab, and had measurable disease. Patients were randomly assigned 1:1 to receive relacorilant 150 mg orally the day before, day of, and day after the nab-paclitaxel infusion, plus nab-paclitaxel 80 mg/m² on days 1, 8, and 15 of each 28-day cycle, or to receive nab-paclitaxel monotherapy 100 mg/m² on the same schedule. Dual primary endpoints were progression-free survival and overall survival.

Study Findings

Between January 5, 2023, and April 8, 2024, 381 patients were randomized, including 188 to relacorilant plus nab-paclitaxel and 193 to nab-paclitaxel alone. All patients had previously received bevacizumab, 44% had received 3 prior lines of therapy, and 61% had received a PARP inhibitor. At a median follow-up of 24.8 months, median overall survival was 16 months (95% CI, 13.0-18.3) in the combination arm vs 11.9 months (95% CI, 10.0-13.8) in the monotherapy arm. Eighteen-month overall survival was 46% vs 27%, respectively.

The final overall survival analysis was conducted after 288 deaths, representing 76% maturity. Investigators also reported significantly improved second progression-free survival, a prespecified exploratory endpoint, with the combination (HR, 0.73; 95% CI, 0.58-0.90; nominal P = .0037). Subsequent anticancer treatments were reported as similar across groups.

Clinical Implications

According to the study authors, the findings suggest that relacorilant plus nab-paclitaxel could represent a potential new standard treatment option for platinum-resistant ovarian cancer without biomarker selection. Safety findings were broadly consistent with the primary analysis, and no new safety signals were identified with additional follow-up. The most common adverse events in the combination arm were neutropenia (64%), anemia (61%), fatigue (54%), and nausea (44%). The authors stated that the study's limitations included its open-label design and uncertain applicability to patients who had received more than 3 prior lines of therapy.

Expert Commentary

“…the addition of relacorilant to nab-paclitaxel showed a progression-free and overall survival benefit in patients with platinum-resistant ovarian cancer,” the researchers concluded.

Reference

Lorusso D, Gladieff L, O’Malley DM, et al. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial. Lancet. 2026;407:1513-1524. doi:10.1016/S0140-6736(26)00462-9