FDA Receives NDA for Relacorilant in Platinum-Resistant Ovarian Cancer

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Corcept Therapeutics has submitted a new drug application (NDA) to the FDA seeking approval of the selective cortisol modulator relacorilant for the treatment of patients with platinum-resistant ovarian cancer.1

The NDA is supported by data from the pivotal phase 3 ROSELLA trial (NCT05257408) and findings from phase 2 studies. Results from ROSELLA presented during the 2025 ASCO Annual Meeting demonstrated that patients who received relacorilant in combination with nab-paclitaxel (Abraxane; n = 188) achieved a median progression-free survival (PFS) by blinded review of 6.54 months (95% CI, 5.55-7.43) vs 5.52 months (95% CI, 3.94-5.88) among those treated with nab-paclitaxel alone (n = 193; HR, 0.70; 95% CI, 0.54-0.91; log-rank P = .0076).2 The 6-month PFS rates were 52% and 42%, and the 12-month PFS rates were 25% and 13%, respectively.

Moreover, at 50% maturity, the median overall survival (OS) in the combination arm was 15.97 months (95% CI, 13.47-not reached) vs 11.50 months (95% CI, 10.02-13.57) in the monotherapy arm (HR, 0.69; 95% CI, 0.52-0.92; log-rank P = .0121). The 12-month OS rates were 60% and 49%, respectively.

“This submission is an important milestone for Corcept as we now have two NDAs before the FDA: relacorilant in combination with nab-paclitaxel as a treatment for [patients] with platinum-resistant ovarian cancer and relacorilant as a treatment for patients with hypercortisolism,” Joseph K. Belanoff, MD, CEO of Corcept Therapeutics, said in a news 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.”

ROSELLA enrolled patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer.2 Patients needed to have received 1 to 3 prior lines of therapy, have an ECOG performance status of 0 or 1, and have undergone prior treatment with bevacizumab (Avastin). Eligible patients were also required to have disease progression less than 6 months after the final dose of platinum-containing therapy, excluding those with no response to or disease progression less than 1 month after primary platinum-containing therapy.

Patients were randomly assigned 1:1 to receive oral relacorilant at 150 mg per day on the day before, the day of, and the day after intravenous (IV) nab-paclitaxel, which was given at 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle; or IV nab-paclitaxel monotherapy at 100 mg/m2 on the same days. Treatment in both arms continued until disease progression or unacceptable toxicity.

The coprimary end points were PFS per RECIST 1.1 criteria per blinded independent central review (BICR) and OS. Secondary end points included investigator-assessed PFS per RECIST 1.1 criteria, objective response rate (ORR), duration of response, clinical benefit rate (CBR), and safety.

Additional data from ROSELLA showed that the ORR in the investigational arm was 36.9%, with a 3.2% complete response (CR) rate, vs an ORR of 30.1% in the control arm, including a CR rate of 2.1%. The CBRs were 51.1% and 38.9%, respectively. Notably, the investigator-assessed PFS benefit in the relacorilant arm was consistent with the benefit reported by BICR (HR, 0.71; P = .0030).

In terms of safety, any-grade treatment-emergent adverse effects (TEAEs) were reported in all patients in the relacorilant arm and 99.5% of those in the nab-paclitaxel monotherapy arm. Patients in both arms experienced grade 3 or higher TEAEs (74.5% vs 59.5%), serious AEs (35.1% vs 23.7%), death within 30 days of the last dose of therapy (5.3% vs 4.2%), dose reductions of nab-paclitaxel due to TEAEs (48.4% vs 31.6%), treatment interruptions due to TEAEs (72.9% vs 54.7%), and treatment discontinuations due to TEAEs (9.0% vs 7.9%). Dose reductions of relacorilant due to TEAEs were reported at a rate of 6.9%.

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://ir.corcept.com/news-releases/news-release-details/corcept-submits-new-drug-application-relacorilant-treatment-0
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. 2025;43(suppl 17):LBA5507. doi:JCO.2025.43.17_suppl.LBA5507