FDA Accepts NDA for Relacorilant in Platinum-Resistant Ovarian Cancer

The FDA has accepted the new drug application (NDA) for relacorilant in combination with nab-paclitaxel as a treatment for patients with platinum-resistant ovarian cancer. This submission is supported by data from the pivotal phase 3 ROSELLA trial (NCT05257408) and earlier phase 2 studies, highlighting a potential new therapeutic option in a population with limited effective treatments.¹

“The FDA's acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease,” said Joseph Belanoff, MD, CEO of Corcept Therapeutics, the sponsor, in a press release. “Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated.”

The randomized phase 3 ROSELLA trial enrolled patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer who experienced disease progression within 6 months of completing platinum-based therapy. Patients received either relacorilant (150 mg orally) the day before, of, and after intravenous nab-paclitaxel (80 mg/m² on days 1, 8, and 15 of each 28-day cycle) or nab-paclitaxel alone at 100 mg/m². The trial’s co-primary end points were progression-free survival (PFS) and overall survival (OS) as assessed by blinded independent central review.

The combination of relacorilant and nab-paclitaxel significantly improved outcomes over nab-paclitaxel alone. The median PFS was 6.54 months (95% CI, 5.55–7.43) in the combination arm vs 5.52 months (95% CI, 3.94–5.88) in the control arm, leading to a hazard ratio (HR) of 0.70 (P =.0076). Six-month and 12-month PFS rates were 52% and 25% in the combination arm compared with 42% and 13% in the control arm, respectively.²

At 50% OS maturity, the median OS was 15.97 months (95% CI, 13.47 to not reached) for the combination vs 11.50 months (95% CI, 10.02–13.57) for monotherapy, with an HR of 0.69 (P =.0121). The 12-month OS rates were 60% and 49%, respectively. These results suggest a meaningful survival benefit with the addition of relacorilant to standard chemotherapy in this difficult-to-treat setting.

Secondary end points further support the efficacy of relacorilant. The objective response rate was 36.9% in the combination group, including 3.2% complete responses, vs 30.1% in the monotherapy group with 2.1% complete responses. The clinical benefit rate was also higher in the relacorilant group (51.1% vs 38.9%). Investigator-assessed PFS aligned with central review findings (HR, 0.71; P =.0030).

Safety data showed that treatment-emergent adverse events (TEAEs) were frequent across both arms, though more common in the combination group. Grade 3 or higher TEAEs occurred in 74.5% of patients in the relacorilant arm vs 59.5% in the control arm.

Serious AEs were reported in 35.1% and 23.7% of patients in the relacorilant vs control arms, respectively. More patients in the combination arm required nab-paclitaxel dose reductions (48.4% vs 31.6%) and treatment interruptions (72.9% vs 54.7%). Discontinuation rates due to AEs were similar between arms (9.0% vs 7.9%), and relacorilant dose reductions occurred in 6.9% of patients.

REFERENCES:

1. FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer. News release. Corcept Therapeutics. September 10, 2025. Accessed September 10, 2025. https://tinyurl.com/52ryfyvj

2. Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. 43(suppl 17):LBA5507. doi:JCO.2025.43.17_suppl.LBA5507