Relacorilant/Nab-Paclitaxel Meets OS End Point in Platinum-Resistant Ovarian Cancer

Relacorilant plus nab-paclitaxel (Abraxane) met the primary end point of the pivotal phase 3 ROSELLA trial (NCT05257408), overall survival (OS), for patients with platinum-resistant ovarian cancer, according to a press release from the developer, Corcept Therapeutics.¹

Among patients treated in ROSELLA, those who received relacorilant with nab-paclitaxel had a 35% reduction in the risk of death compared with patients who received nab-paclitaxel alone (HR, 0.65; P = .0004). The median OS was 16.0 months with the combination therapy vs 11.9 months with nab-paclitaxel alone.

The combination therapy was also well-tolerated, consistent with its expected safety profile. The type, incidence, and severity of adverse events with relacorilant plus nab-paclitaxel were comparable with what was observed for nab-paclitaxel alone.

Notably, more complete results from ROSELLA are going to be presented at an upcoming medical conference.

Previously, in June 2025, results showing a progression-free survival (PFS) benefit with the combination in ROSELLA were simultaneously shared at the 2025 American Society of Clinical Oncology Annual Meeting and published in The Lancet.² Following these results, the FDA accepted a new drug application for the relacorilant regimen in the aforementioned patient population, setting a Prescription Drug User Fee Act date of July 11, 2026.³

The median PFS assessed by blinded review with the combination was 6.54 months (95% CI, 5.55-7.43) vs 5.52 months (95% CI, 3.94-5.88) with nab-paclitaxel alone (HR, 0.70; 95% CI, 0.54-0.91; P = .0076). It was also reported that the overall response rate (ORR) was 36.9% with the combination vs 30.1% with nab-paclitaxel alone (P = .17). Complete responses were noted in 3.2% and 2.1% of each respective group, partial responses were noted in 33.7% and 28.0%, stable disease in 41.2% and 35.2%, and progressive disease in 17.1% and 26.9%. The clinical benefit rate was 51.1% and 38.9%, respectively (P = .016).

“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 profile, and oral administration. Importantly, the phase 3 trial results are not limited to patients with any particular biomarker requirement,” Alexander B. Olawaiye, MD, director of gynecological cancer research at Magee-Women’s Hospital at the University of Pittsburgh, and principal investigator of the ROSELLA trial, stated in the press release.¹ “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.”

The trial enrolled a total of 381 patients with platinum-resistant ovarian cancer across global sites. Patients were randomly assigned, in a 1:1 ratio, to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. Relacorilant was administered orally at 150 mg, and nab-paclitaxel was administered at 80 mg/m² intravenously.

Eligible patients for the trial had epithelial ovarian, primary peritoneal, or fallopian tube cancer, with an ECOG performance status of 0 or 1, progression less than 6 months following their last dose of platinum therapy, 1 to 3 prior lines of therapy, and prior bevacizumab (Avastin).

The dual primary end points of the trial were PFS by RECIST v1.1 per blinded review and OS. Secondary end points included PFS per investigator, ORR, duration of response, combined response, and safety.

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

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. January 22, 2026. Accessed January 22, 2026. https://tinyurl.com/4vms3yvm
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 16):LBA5507. doi:10.1200/JCO.2025.43.17_suppl.LBA5507
3. FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Inc. September 10, 2025. Accessed January 22, 2026. https://tinyurl.com/5yx7cbsp