In the phase III ROSELLA trial—reported at the 2025 ASCO Annual Meeting as well as in The Lancet—Olawaiye et al examined the survival benefit of adding relacorilant to nab-paclitaxel in women with platinum-resistant ovarian cancer. Relacorilant is a first-in-class selective glucocorticoid receptor antagonist that increases tumor sensitivity to chemotherapy by reducing cortisol signaling.
Study Details
In the open-label trial, 381 patients from sites in 14 countries were randomly assigned between January 2023 and April 2024 to receive relacorilant plus nab-paclitaxel (n = 188) or nab-paclitaxel alone (n = 193). Patients received oral relacorilant at 150 mg the day before, the day of, and the day after receipt of their nab-paclitaxel infusion plus nab-paclitaxel at 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle, or nab-paclitaxel monotherapy at 100 mg/m2 on the same schedule. Patients had received up to three previous lines of anticancer therapy and previous bevacizumab, with disease progression on or intolerance to the most recent therapy. The primary endpoints of the study were progression-free survival on blinded independent central review and overall survival.
Key Findings
Median follow-up for progression-free survival was 9.0 months (95% confidence interval [CI] = 7.5–9.8 months). Median progression-free survival was 6.54 months (95% CI = 5.55–7.43 months) in the combination group vs 5.52 months (95% CI = 3.94–5.88 months) in the control group (hazard ratio [HR] = 0.70, 95% CI = 0.54–0.91, P = .0076).
At a planned interim analysis of overall survival, median survival was 15.97 months (95% CI = 13.47 months to not reached) in the combination group vs 11.50 months (95% CI = 10.02–13.57 months) in the control group (HR = 0.69, 95% CI = 0.52–0.92, P = .0121), which did not meet the predefined significance level of < .0001 for the interim analysis.
The combination group had higher rates of grade ≥ 3 adverse events overall (74% vs 59%), serious adverse events (35% vs 24%), and grade ≥ 3 neutropenia (44% vs 25%), anemia (18% vs 8%), and fatigue (9% vs 2%). Adverse events were similar across study groups, with adjustment for the longer nab-paclitaxel exposure in the combination group. One death, due to septic shock in a patient in the combination group, was considered related to nab-paclitaxel.
The investigators concluded: “The addition of relacorilant to nab-paclitaxel prolonged progression-free survival and interim results also showed an improvement in overall survival. Together, the results position the combination of relacorilant and nab-paclitaxel as a potential new standard treatment for patients with platinum-resistant ovarian cancer.”
Alexander B. Olawaiye, MD, of the University of Pittsburgh School of Medicine and UPMC Magee-Women’s Hospital, Gynecologic Oncology Group, is the corresponding author for The Lancet article.
Disclosure: The study was funded by Corcept Therapeutics. For full disclosures of all study authors, visit The Lancet.
