FDA Approves Relacorilant Plus Nab-Paclitaxel for Platinum-Resistant Ovarian Cancer

The FDA has approved relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 systemic treatment regimens, at least 1 of which included bevacizumab (Avastin).¹

This regulatory decision was supported by data from the phase 3 ROSELLA trial (NCT05257408), which enrolled patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received a maximum of 3 prior lines of systemic therapy, including prior bevacizumab (n = 381). In this trial, patients who received relacorilant plus nab-paclitaxel (n = 188) achieved a median progression-free survival (PFS) of 6.5 months (95% CI, 5.6-7.4) vs 5.5 months (95% CI, 3.9-5.9) among those who received nab-paclitaxel alone (n = 193; HR, 0.70; 95% CI, 0.54-0.91; 2-sided P = .0076).^1,2 Furthermore, the median overall survival (OS) was 16 months (95% CI, 13-18.3) in the relacorilant arm vs 11.9 months (95% CI, 10-13.8) in the control arm (HR, 0.65; 95% CI, 0.51-0.83; 2-sided P = .0004).

“[This approval is] clinically very impactful,” Alexander B. Olawaiye, MD, said in an interview with OncLive^®. “This trial was using relacorilant [with a] weekly infusion of nab-paclitaxel in a nonbiomarker-selected population, so there was no testing required for patients to participate in the trial if they met all the other inclusion criteria. [Relacorilant is] available to all comers without biomarker restriction. That is big news.”

Olawaiye is a professor and the vice chair for Diversity, Equity, and Inclusion in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh, director of Gynecologic Cancer Research at Magee-Womens Hospital of the University of Pittsburgh School of Medicine, and principal investigator of the Gynecologic Oncology Group Foundation for the University of Pittsburgh Cancer Institute in Pennsylvania.

What was the design of the ROSELLA trial?

ROSELLA enrollment excluded patients who required frequent or chronic glucocorticoid use. Patients were randomly assigned 1:1 to receive relacorilant at 150 mg the day before, of, and after nab-paclitaxel infusion, plus 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 days 1, 8, and 15 of each 28-day cycle.²

PFS and OS served as the trial’s co–primary end points. Secondary end points included overall response rate (ORR), duration of response, clinical benefit rate (CBR), and safety.

What do the latest efficacy data from ROSELLA show?

Findings presented at the 2025 American Society of Clinical Oncology Annual Meeting and simultaneously published in the Lancet showed a 12-month PFS rate of 25% in the relacorilant arm vs 13% in the control arm. The 12-month OS rates in these arms were 60% and 49%, respectively.

The ORR with relacorilant plus nab-paclitaxel was 36.9% vs 30.1% with nab-paclitaxel alone, translating to a 6.8% improvement with the combination (P = .17). In the relacorilant arm, the rates of complete response, partial response, stable disease, and progressive disease were 3.2%, 33.7%, 41.2%, and 17.1%, respectively; 4.8% of patients were not evaluable for response.

The CBR was 51.1% with relacorilant plus nab-paclitaxel vs 38.9% with nab-paclitaxel alone, translating to a 12.2% improvement with the combination (P = .016).

What is the safety profile of relacorilant plus nab-paclitaxel?

In ROSELLA, the most common adverse effects occurring in more than 20% of patients who received relacorilant plus nab-paclitaxel included decreased hemoglobin levels, decreased neutrophil levels, fatigue, nausea, diarrhea, decreased platelet counts, rash, and decreased appetite.³

The prescribing information for relacorilant notes a contraindication for patients who need corticosteroids for a life-saving indication. The prescribing information also includes warnings and precautions for neutropenia, severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.

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. 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:10.1200/JCO.2025.43.17_suppl.LBA5507
3. Lifyorli. Prescribing information. Corcept Therapeutics; March 2026 Accessed March 25, 2026. https://corcept.com/wp-content/uploads/Lifyorli_PI.pdf