Relacorilant/Nab-Paclitaxel May Increase PFS, OS in Ovarian Cancer

Relacorilant plus nab-paclitaxel (Abraxane) demonstrated greater progression-free survival (PFS) compared with nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer, reaching the phase 3 ROSELLA trial’s (NCT05257408) primary end point.¹

Treatment with relacorilant plus nab-paclitaxel was well tolerated with no new safety signals.

At the data cutoff for the primary analysis, treatment with relacorilant plus nab-paclitaxel resulted in a 30% reduction in the risk of disease progression or death compared with nab-paclitaxel alone (HR, 0.70; P = .008). The median PFS per blinded independent central review (BICR) was 6.5 months in the relacorilant arm vs 5.5 months in the control arm.

An interim analysis of overall survival (OS), the trial’s co-primary endpoint, also favored the relacorilant arm. The median OS was 16.0 months compared with 11.5 months in the control group (HR, 0.69; P = .012).

“Platinum-resistant ovarian cancer poses a significant treatment challenge. The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes,” Domenica Lorusso, MD, PhD, director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, professor of obstetrics and gynaecology at Humanitas University, Rozzano, and investigator in the ROSELLA trial, stated in a news release.

Additionally, relacorilant was well tolerated with no new safety signals observed. The safety and tolerability profile of the combination was consistent with previous data observed in the phase 2 trial (NCT03776812); treatment-emergent adverse effects were comparable between groups.

“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” Bill Guyer, PharmD, chief development officer of Corcept Therapeutics, added in a news release. “We deeply appreciate the patients and investigators who participated in the trial, and we look forward to presenting the trial’s full results in the coming months. We expect to submit our new drug applications in the third quarter and our market authorization application shortly thereafter.”

ROSELLA Study Design and Patient Eligibility Criteria

The global, randomized, double-arm, active-controlled trial enrolled 381 patients with platinum-resistant ovarian cancer across the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia.

Eligible patients were required to have a histologically confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.² Platinum-resistant disease, defined as disease progression within 6 months of completing platinum-based chemotherapy, and 1 to 3 prior lines of systemic anticancer therapy, including prior bevacizumab (Avastin), were needed. Measurable disease per RECIST 1.1 criteria, an ECOG performance status of 0 or 1, and a life expectancy of at least 3 months were required.

Key exclusion criteria included unresolved toxicities to grade 2 or less from prior therapies; major surgery within 4 weeks of enrollment; and select prior or concurrent malignancies within 3 years. Patients with low-grade endometrioid, clear cell, mucinous, or sarcomatous histologies were excluded, as were those with primary platinum-refractory disease, defined as progression within 1 month of first-line platinum therapy.

Patients were randomly assigned 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy. In the experimental arm, patients received nab-paclitaxel at 80 mg/m² administered intravenously on days 1, 8, and 15 of each 28-day cycle plus oral relacorilant at 150 mg once daily on the day before, the day of, and the day after each nab-paclitaxel infusion. Relacorilant was not given on cycle 1, day –1.In the control arm, patients received nab-paclitaxel monotherapy at a dose of 100 mg/m² administered on days 1, 8, and 15 of each 28-day cycle.

Dual primary end points were PFS as assessed by BICR and OS.

“Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies. The ROSELLA results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer,” Alexander B. Olawaiye, MD, director of Gynecological Cancer Research at Magee-Women’s Hospital of the University of Pittsburgh and principal investigator in the ROSELLA trial, stated in a news release.¹

References

1. Primary endpoint met in Corcept’s pivotal phase 3 ROSELLA trial of relacorilant in patients with platinum-resistant ovarian cancer. News Release. Corcept Therapeutics. March31, 2025. Accessed March 31, 2025. https://ir.corcept.com/news-releases/news-release-details/primary-endpoint-met-corcepts-pivotal-phase-3-rosella-trial
2. Relacorilant in combination with nab-paclitaxel in advanced, platinum-resistant, high-grade epithelial ovarian, primary peritoneal, or fallopian-tube cancer. ClinicalTrials.gov. Updated March 25, 2025. Accessed March 31, 2025. https://clinicaltrials.gov/study/NCT05257408