Corcept Therapeutics says Phase 3 ROSELLA trial met primary endpoint

Corcept Therapeutics (CORT) shared data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the ASCO 2025 Annual Meeting. ROSELLA met its primary endpoint of improved progression-free survival as assessed by blinded independent central review. Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients who received nab-paclitaxel monotherap. Median PFS-BICR was extended to 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. In addition, PFS assessed by investigators was consistent with PFS-BICR, with a hazard ratio of 0.71. An interim analysis of overall survival, showed that the addition of relacorilant reduced the risk of death by 31%, substantially lengthening patients’ lives. Median OS for patients who received relacorilant was 16.0 months, compared to 11.5 months for patients who received nab-paclitaxel alone. These benefits were seen in all clinically relevant subgroups, including those with poor prognoses. Relacorilant plus nab-paclitaxel was well-tolerated, with a comparable safety profile between treatment arms. The addition of relacorilant did not increase patients’ safety burden. In addition, patients treated with relacorilant plus nab-paclitaxel had a lower incidence of ascites (5.3%), than did patients who received nab-paclitaxel alone (10.5%). The occurrence of abdominal paracenteses during treatment was also lower for patients treated with relacorilant plus nab-paclitaxel (7.4%), compared to nab-paclitaxel alone (13.2%).