Relacorilant NDA Is Under FDA Review for Platinum-Resistant Ovarian Cancer

The FDA has accepted a new drug application (NDA) seeking the approval of relacorilant for the treatment of patients with platinum-resistant ovarian cancer (PROC), and has assigned a Prescription Drug User Fee Act decision date of July 11, 2026.1

The NDA was supported by findings from the phase 3 ROSELLA trial (NCT05257408), as well as data from phase 2 trials. Combined, these trials demonstrated that treatment with relacorilant plus nab-paclitaxel (Abraxane) resulted in improved progression-free survival (PFS) and overall survival (OS) outcomes vs nab-paclitaxel alone, with no biomarker selection required. Additionally, this body of research showed that relacorilant was well tolerated, a finding consistent with the agent’s known safety profile. The adverse effects (AEs) seen with relacorilant plus nab-paclitaxel were similar in type, frequency, and severity compared with those seen with nab-paclitaxel alone, according to a news release from Corcept Therapeutics, the drug developer.

“The FDA’s acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease,” Joseph Belanoff, MD, CEO of Corcept Therapeutics, stated in a news release. “Relacorilant has the potential to redefine how PROC is treated.”

What Were the Key Efficacy Findings From the ROSELLA Trial?

ROSELLA enrolled patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer who had received between 1 and 3 prior lines of therapy, had an ECOG performance status of 0 or 1, and had received prior treatment with bevacizumab (Avastin).2,3 Patients also needed to have disease progression less than 6 months following their final dose of platinum-containing therapy.

Patients were randomly assigned 1:1 to treatment with oral relacorilant at 150 mg daily on the day before, the day of, and the day after receiving intravenous (IV) nab-paclitaxel 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. All patients continued treatment until disease progression or unacceptable toxicity. The dual primary end points of the study were PFS by blinded independent central review and RECIST v1.1 criteria and OS.

Data from ROSELLA presented at the 2025 ASCO Annual Meeting and the 2025 ESMO Gynecological Cancers Congress showed that relacorilant plus nab-paclitaxel (n = 188) led to a median PFS of 6.54 months (95% CI, 5.55-7.43) compared with 5.52 months (95% CI, 3.94-5.88) with nab-paclitaxel monotherapy (n = 193), translating to a 30% reduction in the risk of disease progression or death (HR, 0.70; 95% CI, 0.54-0.91; log-rank P = .0076). In the relacorilant arm, the 6- and 12-month PFS rates were 52% and 25%, respectively; these respective rates were 42% and 13% in the nab-paclitaxel-alone arm.

At the time of this analysis, the OS data had reached 50% maturity. The median OS was 15.97 months (95% CI, 13.47-not reached [NR]) in the relacorilant arm vs 11.50 months (95% CI, 10.02-13.57) in the nab-paclitaxel alone arm (HR, 0.69; 95% CI, 0.52-0.92; log-rank P = .0121). The 12-month OS rates in these respective arms were 60% and 49%.

Furthermore, in the relacorilant arm, the overall response rate per RECIST 1.1. criteria was 36.9%, and the complete response rate was 3.2%; in the control arm, these respective rates were 30.1% and 2.1% (P = .17). The clinical benefit rates in these respective arms were 51.1% and 38.9% (P = .016).

Additional data presented at the 2025 ESMO Gynecological Cancers Congress showed that the addition of relacorilant to nab-paclitaxel improved PFS and OS across key patient subgroups.3 Among those with a primary platinum-free interval of 1 to 6 months, the median PFS was 5.82 months (95% CI, 5.29-7.89) in the relacorilant arm (n = 54) vs 3.94 months (95% CI, 2.73-5.78) in the control arm (n = 58; HR, 0.50; 95% CI, 0.30-0.84; nominal P = .0081). In this population, the median OS was NR (95% CI, 8.44-NR) with the addition of relacorilant vs 9.56 months (95% CI, 6.05-11.50) with nab-paclitaxel alone (HR, 0.52; 95% CI, 0.31-0.89; nominal P = .0140).

What Were the Safety Findings in the ROSELLA Trial?

Any-grade treatment-emergent AEs were reported in 100% of patients in the relacorilant arm vs 99.5% of those in the nab-paclitaxel alone arm.2,3 The most common AEs in the relacorilant arm were neutropenia (any-grade, 64%; grade ≥ 3, 44%), anemia (61%; 18%), fatigue (53%; 9%), nausea (44%; 4%), diarrhea (39%; 4%), alopecia (38%; 1%), constipation (32%; 1%), abdominal pain (29%; 2%), vomiting (26%; 3%) and decreased appetite (22%; 2%).

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://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-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
3. Lorusso D, Gladieff L, Gilbert L, et al. Phase III results of relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer (PROC) (ROSELLA, GOG-3073, ENGOT-ov72): secondary endpoints. Presented at: 2025 ESMO Gynecological Cancer Congress; June 19-21, 2025; Vienna, Austria. Abstract 70O.