Relacorilant Demonstrates Significant OS in Platinum-Resistant Ovarian Cancer

The phase 3 ROSELLA trial (NCT05257408) has successfully met its primary end point for overall survival (OS), demonstrating that the addition of relacorilant to nab-paclitaxel chemotherapy significantly extends the lives of patients with platinum-resistant ovarian cancer.^1,2

The data show a 35% reduction in the risk of death, translating to a 4.1-month improvement in median OS compared with nab-paclitaxel alone. This positive OS result follows the previously announced success in meeting the trial's other dual primary end point, progression-free survival (PFS), which showed a 30% reduction in the risk of disease progression.

The median OS for relacorilant plus nab-paclitaxel was 16.0 months vs 11.9 months for nab-paclitaxel alone.

The trial also met its primary end point of PFS, as assessed by blinded independent central review. These findings were first presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and were simultaneously published in The Lancet.

Crucially, these substantial efficacy benefits were achieved without increasing the safety burden on patients; the combination therapy's safety profile was comparable to that of chemotherapy alone. The most frequently reported adverse events were known toxicities of nab-paclitaxel: anemia (58%), neutropenia (56%), and nausea (39%).³

“These data clearly demonstrate the potential of relacorilant plus nab-paclitaxel to extend [OS] and [PFS] in patients with advanced, recurrent ovarian cancer,” said Domenica Lorusso, MD, PhD, director of the Gynecological Oncology Unit at Humanitas Hospital San Pio X in Milan, and professor of Obstetrics and Gynecology at Humanitas University, and an investigator in the ROSELLA trial, in a news release.¹ “These tumors eventually become resistant to chemotherapy and providing oncologists with relacorilant plus nab-paclitaxel could greatly benefit patients.”

The ROSELLA trial was a randomized, international study with an enrollment of 381 patients with platinum-resistant ovarian cancer. The trial was conducted at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia.

Patients were randomized 1:1 to receive either relacorilant (150 mg the day before, day of, and day after nab-paclitaxel) plus nab-paclitaxel (80 mg/m² on days 1, 8, and 15 of each 28-day cycle) or nab-paclitaxel alone (100 mg/m² on the schedule). Randomization was stratified by prior lines of therapy and region.³

New drug and marketing authorization applications are currently under review by the FDA and European Medicines Agency, with a Prescription Drug User Fee Acttarget action date of July 11, 2026.¹

Corcept Therapeutics, sponsor of the ROSELLA trial, is currently evaluating relacorilant in other solid tumors, including platinum-sensitive ovarian cancer, endometrial cancer, cervical cancer, pancreatic cancer, and prostate cancer.

"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 [safety] profile and oral administration,” said Alexander B. Olawaiye, MD, principal investigator of the ROSELLA trial, in a news release. “Importantly, the [p]hase 3 trial results are not limited to patients with any particular biomarker requirement."

REFERENCES

1.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. Published January 22, 2026. Accessed January 22, 2026. https://tinyurl.com/44vc59nj

2.Relacorilant in combination with nab-paclitaxel in advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. ClinicalTrials.gov. Updated April 16, 2025. Accessed January 22, 2026. https://clinicaltrials.gov/study/NCT05257408

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 43, LBA5507(2025). Published June 4, 2025. Accessed January 23, 2026. Volume 43, Number 17_suppl. doi: 10.1200/JCO.2025.43.17_suppl.LBA5507.