Dr Gilbert on the Efficacy of Relacorilant Plus Nab-Paclitaxel in Ovarian Cancer

“We were pleased, for the sake of our patients, that it was a positive trial.”

Lucy Gilbert, MD, MSc, FRCOG, a professor in the Department of Obstetrics and Gynecology and the Department of Oncology, as well as director of Gynecologic Oncology and director of the Women’s Health Research Unit at McGill University and the McGill University Health Centre, discussed findings from the phase 3 ROSELLA trial (NCT05257408) evaluating the selective glucocorticoid receptor antagonist relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer.

ROSELLA was a large, open-label, randomized, controlled trial in a difficult-to-treat population, Gilbert said. The study compared the combination of relacorilant plus nab-paclitaxel with nab-paclitaxel monotherapy. The dual primary end points were progression-free survival (PFS) and overall survival (OS). In the primary analysis, relacorilant plus nab-paclitaxel produced a 30% improvement in median PFS (HR, 0.70; 95% CI, 0.54-0.91; P = .0076) and reduced the risk of death by 35% (HR, 0.65; 95% CI, 0.51-0.83; P = .0004), a benefit achieved with little added toxicity, Gilbert noted. The main toxicities were comparable between the arms and included neutropenia, nausea, and gastrointestinal symptoms, she added, noting that and treatment discontinuation rates were also similar between the arms.

An updated analysis presented at the 2026 ASCO Annual Meeting examined OS outcomes by prior taxane use. The OS benefit favored the relacorilant combination across all prespecified subgroups: among patients with a taxane-free interval of 6 months or less, the hazard ratio (HR) was 0.60 (95% CI, 0.31-1.15), and among those with an interval longer than 6 months, it was 0.66 (95% CI, 0.51-0.86). Similarly, the HR was 0.67 (95% CI, 0.38-1.19) for patients who had received a taxane in their most recent regimen and 0.63 (95% CI, 0.48-0.82) for those who had not.

The safety profile of relacorilant plus nab-paclitaxel at the final analysis remained consistent with that at the primary analysis, with no new safety signals, no relacorilant-related fatal adverse effects, and no cases of adrenal insufficiency.