Relacorilant Plus Nab-Paclitaxel Improves PFS for Patients With Platinum-Resistant Ovarian Cancer
According to Corcept Therapeutics Incorporated, phase 3 ROSELLA trial has met its primary end point of improved progression-free survival (PFS) by blinded independent central review with relacorilant plus nab-paclitaxel among patients with platinum-resistant ovarian cancer, compared with nab-paclitaxel alone.
“As there are no currently approved therapies or effective standard of care for heavily pretreated patients with ovarian cancer who have exhausted single-agent chemotherapy and/or bevacizumab, the combination of intermittently administered relacorilant and nab-paclitaxel may demonstrate a substantial improvement without increased toxicity compared with nab-paclitaxel,” stated study authors.
In this open-label study, 381 patients were randomized on a 1-to-1 basis to receive either 80 mg/m2 of intravenous nab-paclitaxel (on days 1, 8, and 15) plus 150 mg of once daily relacorilant in 28 day cycles or 100 mg/m2 of intravenous nab-paclitaxel monotherapy (on days 1, 8, and 15), in 28 day cycles until disease progression or unacceptable toxicity. Primary end points included progression-free survival (PFS) and overall survival (OS). A key secondary end point was safety.
Corcept Therapeutics Incorporated reports a 30% reduction in risk of disease progression in the relacorilant plus nab-paclitaxel arm (hazard ratio [HR] 0.70; P = .008). The median PFS was 6.5 months in the relacorilant plus nab-paclitaxel arm and 5.5 months in the nab-paclitaxel monotherapy arm. The median OS was 16 months and 11.5 months (HR 0.69; P = .012), respectively. No new safety signals were observed.
“Results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes,” concluded Domenica Lorusso, MD, PhD, Humanitas Hospital San Pio X, Milan, Italy.
Sources:
Primary end point met in Corcept’s pivotal phase 3 ROSELLA trial of relacorilant in patients with platinum-resistant ovarian cancer. Accessed on April 4, 2025. https://ir.corcept.com/news-releases/news-release-details/primary-endpoint-met-corcepts-pivotal-phase-3-rosella-trial
Relacorilant in combination with nab-paclitaxel in advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. Accessed on April 4, 2025. https://clinicaltrials.gov/study/NCT05257408#study-plan
.
