NDA for Relacorilant in Platinum-Resistant Ovarian Cancer Submitted to FDA

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  • A new drug application (NDA) for relacorilant has been submitted to the FDA based on phase 3 ROSELLA (NCT05257408) data.
  • Relacorilant plus nab-paclitaxel significantly improved progression-free survival (PFS) and overall survival (OS) in platinum-resistant ovarian cancer compared with nab-paclitaxel alone.
  • Safety signals included higher rates of adverse events (AEs) and dose modifications in the combination arm.

An NDA has been submitted to the FDA 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 and earlier phase 2 studies, highlighting a potential new therapeutic option in a population with limited effective treatments.1

The randomized phase 3 ROSELLA trial enrolled patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer who had 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 PFS and OS 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, yielding 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

Concept of gynecologic cancer: © tom – stock.adobe.com

“This submission is an important milestone for Corcept as we now have 2 new drug applications before the FDA: Relacorilant in combination with nab-paclitaxel as a treatment for people with platinum-resistant ovarian cancer and relacorilant as a treatment for patients with hypercortisolism,” said Joseph K. Belanoff, MD, Corcept’s chief executive officer, in a press release.1 “Better treatment options are needed for the many patients living with these diseases. Our oncology and endocrinology business units are already working to make sure relacorilant is available immediately following regulatory approval.”

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.2

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 (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, 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. Corcept submits new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics. July 14, 2025. Accessed July 14, 2025. https://tinyurl.com/4ww28bcs
  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

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