Relacorilant Extends Survival in Platinum-Resistant Ovarian Cancer

Concept of gynecologic cancer: © tom - stock.adobe.com

Relacorilant combined with nab-paclitaxel (Abraxane) improved progression-free survival (PFS) and overall survival (OS) vs nab-paclitaxel alone in patients with platinum-resistant ovarian cancer, meeting the co-primary end points of the phase 3 ROSELLA trial (NCT05257408).¹

At the data cutoff for the primary analysis, patients treated with relacorilant and nab-paclitaxel had a 30% reduction in the risk of disease progression or death compared with those given nab-paclitaxel alone (HR, 0.70; P = .008). The median PFS rates per blinded independent central review (BICR) in the relacorilant plus nab-paclitaxel and nab-paclitaxel alone arms were 6.5 months and 5.5 months, respectively.

For the co-primary endpoint of OS, findings from an interim analysis showed the median OS to be 16.0 months in the relacorilant arm vs 11.5 months in the control arm (HR, 0.69; P = .012).

Looking at safety, relacorilant was well tolerated, no new safety signals were seen, and findings were comparable between the 2 arms.

“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,” said 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, in a press release.

Full results from the ROSELLA trial will be presented at an upcoming medical meeting. Results from the phase 2 trial of relacorilant in patients with platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology in June 2023.

“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,” stated Bill Guyer, PharmD, chief development officer of Corcept Therapeutics, in the press 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.”

About the ROSELLA Trial

ROSELLA is a global, randomized, double-arm, active-controlled trial which enrolled 381 patients with platinum-resistant ovarian cancer who were randomly assigned in a 1:1 fashion to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.²

Enrollment was open to patients with a histologically confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.² Patients were required to have 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), measurable disease per RECIST 1.1 criteria, a life expectancy of 3 months or more, adequate organ function, and an ECOG performance status of 0 or 1.

Patients in the experimental arm were given nab-paclitaxel at a dose of 80 mg/m² administered via intravenous infusion 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.

Those in the control arm were given nab-paclitaxel as a monotherapy at a dose of 100 mg/m² on days 1, 8, and 15 of each 28-day cycle.

The primary end points of the study were PFS as assessed by BICR and OS. Secondary end points include PFS as assessed by the investigator, objective response rate, best overall response, duration of response, clinical benefit rate, cancer antigen-25 response, and combined response according to RECIST v1.1 and Gynaecologic Cancer Intergroup.

“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,” added 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, in the press 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://tinyurl.com/ymjtz9pb

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