FDA Greenlights Relacorilant/Nab-Paclitaxel in PROC

The FDA has approved relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) for the treatment of adult patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer (PROC) following 1 to 3 prior lines of systemic therapy including bevacizumab (Avastin).¹

The efficacy of the combination was evaluated in the multicenter, open-label phase 3 ROSELLA trial (NCT05257408), which met its overall survival (OS) primary end point in January.² The major efficacy outcomes were progression-free survival (PFS) assessed by blinded independent central review and OS.¹ The median PFS was 6.5 months (95% CI, 5.6-7.4) in the relacorilant combination arm vs 5.5 months (95% CI, 3.9-5.9) in the nab-paclitaxel monotherapy arm.

Relacorilant, a selective glucocorticoid receptor antagonist, plus nab-paclitaxel reduced the risk of death by 35% compared with solo nab-paclitaxel, with a median OS of 16 months (95% CI, 13-18.3) in the combination arm vs 11.9 months (95% CI, 10-13.8) in the monotherapy arm (HR, 0.65; 95% CI, 0.51-0.83; P = .0004).

The study involved 381 patients with PROC who had received as many as 3 prior lines of systemic therapy including bevacizumab. Patients were randomly assigned 1:1 to receive either the relacorilant combination or nab-paclitaxel alone. Those who required chronic or frequent use of glucocorticoids were excluded from the trial.

“The use of relacorilant combined with nab-paclitaxel does not require biomarker selection, which means there is no special testing that needs to be done for a patient to be eligible for this combination when it becomes available,” explained Alexander Olawaiye, MD, who shared ROSELLA data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, in an interview with Oncology Nursing News.

Olawaiye, a professor of gynecologic oncology at the University of Pittsburgh and Magee-Women’s Hospital of UPMC in Pittsburgh, Pennsylvania, is a primary investigator for ROSELLA.

Nursing Notes: Relacorilant/Nab-Paclitaxel Dosing and Safety

Relacorilant should be administered at 150 mg orally once the day before, the day of, and the day following every nab-paclitaxel infusion until disease progression or unacceptable toxicity. Nab-paclitaxel is recommended at 80 mg/m² intravenously on days 1, 8, and 15 of a 28-day cycle.

The combination is contraindicated for patients who require lifesaving corticosteroid use. Further, clinicians should be aware of warnings for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions that are treated using glucocorticoids, and embryo-fetal toxicity.

The most frequent adverse effects (AEs) associated with the combination included decreased hemoglobin, neutropenia, fatigue, nausea, diarrhea, thrombocytopenia, rash, and decreased appetite.

Prior ROSELLA Findings and Updates

Positive findings from ROSELLA and a prior phase 2 trial (NCT03776812) led to the FDA accepting a new drug application for the combination in September.³ At that time, the combination was given a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, indicating that the FDA approved the regimen more than 3 months ahead of its planned action date.

Data presented at the 2025 European Society of Medical Oncology (ESMO) Gynecologic Cancers Congress in June 2025 demonstrated that relacorilant plus nab-paclitaxel improved survival for patients with PROC following a 1- to 6-month break from platinum-based chemotherapy.⁴

Before that, findings presented at the 2025 ASCO Annual Meetingshowed a PFS benefit for patients with PROC receiving the combination, with a PFS of 6.54 months (95% CI, 5.55-7.43) with relacorilant/nab-paclitaxel compared with 5.52 months (95% CI, 3.94-5.88) with nab-paclitaxel alone, yielding a 30% reduction in the risk of disease progression or death (HR, 0.70; 95% CI, 0.54-0.91; P = .0076).⁵

References

1. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA. March 25, 2026. Accessed March 25, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
2. Overall survival primary endpoint met in Corcept’s pivotal phase 3 ROSELLA trial of relacorilant in patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Inc. January 22, 2026. Accessed March 25, 2026. https://www.businesswire.com/news/home/20260122359919/en/Overall-Survival-Primary-Endpoint-Met-in-Corcepts-Pivotal-Phase-3-ROSELLA-Trial-of-Relacorilant-in-Patients-with-Platinum-Resistant-Ovarian-Cancer
3. FDA files corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept Therapeutics. News release. 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
4. 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.
5. 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:10.1200/JCO.2025.43.17_suppl.LBA5507