Relacorilant/Chemo Show Survival Benefit in Platinum-Resistant Ovarian Cancer

Relacorliant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer revealed a 30% reduction in the risk of disease progression compared with nab-paclitaxel alone (HR, 0.70; P = .008).

Relacorilant plus nab-paclitaxel met the primary end point of progression-free survival (PFS), and maintained a comparable adverse effect (AE) profile vs nab-paclitaxel alone in patients with platinum-resistant ovarian cancer, according to a news release from the drug’s developer, Corcept Therapeutics.1

Findings from the phase 3 ROSELLA trial (NCT05257408) assessing relacorliant/nab-paclitaxel in patients with platinum-resistant ovarian cancer revealed a 30% reduction in the risk of disease progression with the investigational combination compared with nab-paclitaxel alone (HR, 0.70; P = .008). Furthermore, the median PFS per blinded independent central review (PFS-BICR) was 6.5 months vs 5.5 months in each respective arm.

Additional data showed an overall survival (OS) of 16.0 months with relacorilant plus nab-paclitaxel vs 11.5 months with nab-paclitaxel alone during an interim OS analysis (HR, 0.69; P = .012). Relacorilant was well-tolerated and no new safety signals were observed, with safety and tolerability considered comparable between patients assigned to the investigational and control groups.

The results from the phase 3 ROSELLA trial will support a new drug application and marketing authorization application for the relacorilant combination in patients with PROC.

“Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies. The [phase 3 ROSELLA trial] results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer,” ROSELLA principal investigator, Alexander B. Olawaiye, MD, director of gynecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh, said in the news release.1

A total of 381 patients with platinum-resistant ovarian cancer were enrolled on the phase 3 ROSELLA trial and were randomly assigned 1:1 to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The co-primary end points were PFS and OS; a positive outcome is considered achieved if either end point is met. Secondary end points included investigator-assessed PFS, objective response rate, duration of response, clinical benefit rate, and safety.2

Patients in the investigational arm received 80 mg/m2 of intravenous nab-paclitaxel over 30 to 40-minute infusions on days 1, 8, and 15 of 28-day cycles with intermittent relacorliant, given as a 150 mg oral dose once daily the day before, of, and after receipt of nab-paclitaxel. Relacorilant was not given on cycle 1 day –1. Patients in the comparator arm received 100 mg/m2 of nab-paclitaxel on days 1, 8, and 15 of 28-day cycles.

Patients were eligible for enrollment if they had: a confirmed histologic diagnosis of platinum-resistant high-grade serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma; a life expectancy of 3 months or greater; at least 1 lesion with measurable disease by RECIST v 1.1; an ECOG performance status score of 0 or 1; received between 1 and 3 prior systemic anticancer therapy and at least 1 prior line of platinum therapy and prior bevacizumab (Avastin); and adequate organ function.

Patients were excluded from trial participation if they had; clinically relevant toxicity; major surgery within 4 weeks of random assignment; were treated with chemotherapy, immunotherapy, or investigational agents for disease within 28 days of the first dose of study drug; received radiotherapy less than 2 weeks before receipt of study drug, hormonal anticancer therapy within 7 days of random assignment; or topical corticosteroids within 21 days of study drug; or if they had unresolved AEs from prior therapies; among other criteria.

“Platinum-resistant ovarian cancer poses a significant treatment challenge. The [phase 3 ROSELLA trial] results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes,” ROSELLA investigator, Domenica Lorusso, MD, PhD, director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and full professor of Obstetrics and Gynaecology, Humanitas University, Rozzano, said in the 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. March 31, 2025. Accessed March 31, 2025. https://tinyurl.com/y5ctdfbn
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://tinyurl.com/4jbfzkxf