Clinical Summary: 

• Design/Population: In the phase 3 ROSELLA trial, patients with platinum-resistant ovarian cancer were randomized to receive relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy.
• Key Outcomes: Relacorilant plus nab-paclitaxel significantly improved overall survival compared with nab-paclitaxel alone, with benefit observed irrespective of prior taxane exposure.
• Clinical Relevance: These findings support relacorilant plus nab-paclitaxel as a potential new treatment option for platinum-resistant ovarian cancer, including in patients previously treated with taxanes.

Final subgroup analysis results from the phase 3 ROSELLA trial demonstrated that relacorilant plus nab-paclitaxel significantly improved overall survival (OS) among patients with platinum-resistant ovarian cancer. 

These results were presented by Lucy Gilbert, MD, MSc, McGill University Health Centre, Montreal, Canada, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

In this study, 381 patients were randomized 1:1 to receive either 150 mg of relacorilant once daily on the day before, the day of, and the day after receiving 80 mg/m² of nab-paclitaxel on days 1, 8, and 15 of each 28-day cycle or 100 mg/m² of nab-paclitaxel alone. The primary end point was OS, conducted after 288 deaths had occurred, representing 76% data maturity. A Key secondary end point was OS based on taxane-free interval and prior taxane use. 

At a median follow-up of 24.8 months, median OS was 16 months in the relacorilant arm and 11.9 months in the nab-paclitaxel arm (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.51 to 0.83; P = .0004). Median OS was improved by 5.7 months in patients with a taxane-free interval of ≤6 months and 3.6 months in patients with a taxane-free interval >6 months, and improved by 3.9 months in patients who received a taxane in the most recent regimen and 4.2 months in patients who did not receive a taxane in the most recent regimen. 

“Relacorilant plus nab-paclitaxel demonstrated a statistically and clinically significant OS benefit in patients with PROC compared to a weekly taxane, the most efficacious chemotherapy,” concluded Dr Gilbert. “Subgroup analyses for OS showed a consistent benefit favoring the addition of relacorilant to nab-paclitaxel irrespective of prior taxane use.”

Source:

Gilbert L, You B, Olawaiye A, et al. Overall survival subgroup analyses for prior taxane use in the phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72, APGOT-Ov10, LACOG-0223, and ANZGOG-2221/2023). Presented at the ASCO Annual Meeting. May 29 - June 2, 2026. Chicago, Illinois. Abstract 5503.