Dr Olawaiye on Updated OS Data With Relacorilant Plus Nab-Paclitaxel in PROC

“The dual primary end points were PFS and OS. [At ASCO 2025], the PFS data were positive and now the mature [OS] data are [also] positive.”

Alexander B. Olawaiye, MD, the vice chair for DEI in the Department of Obstetrics, Gynecology and Reproductive Sciences as well as director of gynecologic cancer research at Magee-Women’s Hospital of the University of Pittsburgh Medical Center, discussed updated overall survival (OS) data from the phase 3 ROSELLA trial (NCT05257408), which evaluated relacorilant plus nab-paclitaxel (Abraxane) for the treatment of patients with platinum-resistant ovarian cancer (PROC).

The coprimary end points of ROSELLA were OS and progression-free survival (PFS), Olawaiye began. Key secondary end points included overall response rate, duration of response, clinical benefit rate, and safety.Prior data from the study presented during the 2025 ASCO Annual Meeting demonstrated that patients with PROC who received relacorilant plus nab-paclitaxel (n = 188) achieved a median PFS of 6.54 months (95% CI, 5.55-7.43) compared with 5.52 months (95% CI, 3.94-5.88) among those treated with nab-paclitaxel alone (n = 193; HR, 0.70; 95% CI, 0.54-091; P = .0076), he added. However, OS data were immature at the time of this presentation, he noted.

In January 2026, Corcept Therapeutics, the developer of relacorilant, announced that ROSELLA had met its OS end point, Olawaiye said. Findings published in a news release showed that the median OS was 16.0 months in the combination arm compared with 11.9 months in the monotherapy arm. These findings translated into a 35% reduction in the risk of death in favor of the relacorilant arm (HR, 0.65; P = .0004). Of note, full data from ROSELLA will be shared at an upcoming medical meeting.

Relacorilant is a novel selective glucocorticoid receptor antagonist that is designed to modulate the effects of cortisol by binding to the glucocorticoid receptor without affecting other hormone receptors.