The addition of the investigational selective glucocorticoid receptor antagonist relacorilant to nab-paclitaxel (Abraxane) significantly improved overall survival (OS) compared with nab-paclitaxel alone in patients with platinum-resistant ovarian cancer (PROC), meeting a coprimary end point of the pivotal phase 3 ROSELLA trial (NCT05257408).1
Patients treated with the combination of relacorilant and nab-paclitaxel experienced a 35% reduction in the risk of death compared with those treated with nab-paclitaxel alone (HR, 0.65; P = .0004). The median OS was 16.0 months for the relacorilant arm vs 11.9 months for the monotherapy arm, representing a 4.1-month improvement. Full data from ROSELLA are expected to be shared at a future medical meeting.
“The addition of relacorilant to nab-paclitaxel, a trusted and effective chemotherapy, is positioned to become a new standard-of-care treatment for patients with platinum-resistant ovarian cancer, due to its OS benefit, well-tolerated adverse effect [AE] profile, and oral administration,” Alexander B. Olawaiye, MD, director of Gynecological Cancer Research at Magee-Women’s Hospital of the University of Pittsburgh in Pennsylvania, as well as the ROSELLA principal investigator, stated in a news release. “Importantly, the phase 3 trial results are not limited to patients with any particular biomarker requirement. ROSELLA’s findings compel us to evaluate relacorilant as a treatment for earlier stages of ovarian cancer and for other tumors that express the glucocorticoid receptor, such as endometrial and cervical cancer.”
Relacorilant is designed as a proprietary, selective glucocorticoid receptor antagonist that modulates the effects of cortisol by binding to the glucocorticoid receptor without affecting other hormone receptors.
ROSELLA Trial: Key Data and Regulatory Status
- The ROSELLA trial demonstrated that adding relacorilant to nab-paclitaxel significantly improved both OS and PFS in patients with PROC, reducing the risk of death by 35%.
- Relacorilant was shown to be well tolerated with a safety profile comparable with that of chemotherapy alone and is administered orally, positioning it as a potential new standard of care regardless of patients’ biomarker status.
- Following the successful global trial, Corcept Therapeutics—the developer of relacorilant—has submitted regulatory applications in the US and Europe, with an FDA Prescription Drug User Fee Act target action date of July 11, 2026.
How was the ROSELLA trial designed?
The pivotal, randomized study enrolled 381 patients with PROC across global sites in the US, Europe, South Korea, Brazil, Argentina, Canada, and Australia. Patients were randomly assigned 1:1 to receive either the combination of oral 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
The dual primary end points were PFS and OS. Secondary end points included overall response rate, duration of response, clinical benefit rate, and safety.
The trial was conducted in collaboration with several major oncology groups, including the GOG Foundation, the European Network of Gynaecological Oncological Trial groups, and the Asia-Pacific Gynecologic Oncology Trials Group. 1
What additional efficacy findings have been presented from ROSELLA?
Data previously presented at the 2025 ASCO Annual Meeting and simultaneously published in The Lancet showed that the study met its other coprimary end point of progression-free survival (PFS), as assessed by blinded independent central review, showing a 30% reduction in the risk of disease progression (HR, 0.70; 95% CI, 0.54-091; P = .0076).2 The median PFS was 6.54 months (95% CI, 5.55-7.43) with the combination (n = 188) vs 5.52 months (95% CI, 3.94-5.88) with nab-paclitaxel alone (n = 193).
“These data clearly demonstrate the potential of relacorilant plus nab-paclitaxel to extend OS and PFS in patients with advanced, recurrent ovarian cancer,” Domenica Lorusso, MD, PhD, director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X in Milan, Italy; a full professor of obstetrics and gynaecology at Humanitas University, Rozzano, in Italy; and an investigator in the ROSELLA trial, added in the news release.1 “These tumors eventually become resistant to chemotherapy, and providing oncologists with relacorilant plus nab-paclitaxel could greatly benefit patients.”
What updated safety data have been reported with the relacorilant combination?
The combination of relacorilant and nab-paclitaxel was reported to be well tolerated, according to the news release, with a safety profile consistent with previous findings. Importantly, investigators noted that the type, frequency, and severity of AEs in the combination arm were comparable with those observed in the nab-paclitaxel monotherapy arm. Relacorilant appeared to confer its clinical survival benefits without increasing the safety burden for patients who received it.
What is the current regulatory status of relacorilant?
The FDA has accepted and assigned a Prescription Drug User Fee Act target action date of July 11, 2026, to a new drug application seeking the approval of relacorilant as a treatment for patients with PROC.3 In addition to the US filing, a marketing authorization application has been submitted to the European Medicines Agency for the agent in this indication.4 Relacorilant has already received orphan drug designation for the treatment of ovarian cancer from the European Commission.1
Beyond PROC, relacorilant is currently being evaluated for the management of earlier stages of ovarian cancer, as well as other solid tumors, including endometrial, cervical, pancreatic, and prostate cancers.
References
- 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 Incorporated. January 22, 2026. Accessed January 22, 2026. https://ir.corcept.com/news-releases/news-release-details/overall-survival-primary-endpoint-met-corcepts-pivotal-phase-3
- 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
- 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 January 22, 2026. https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0
- Corcept submits marketing authorization application to European Medicines Agency for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics. October 14, 2025. Accessed January 22, 2026. https://ir.corcept.com/news-releases/news-release-details/corcept-submits-marketing-authorization-application-european
