Relacorilant-nab-paclitaxel Improves Survival in Ovarian Cancer Despite Prior Taxane Use
The phase 3 ROSELLA trial showed relacorilant plus nab-paclitaxel significantly improved overall survival in platinum-resistant ovarian cancer by 4.1 months versus nab-paclitaxel alone. The benefit was consistent across all subgroups regardless of prior taxane exposure, leading to FDA approval in March 2026. The combination also met its progression-free survival endpoint and demonstrated a favorable safety profile.
Relacorilant combined with nab-paclitaxel demonstrated a statistically significant and clinically meaningful improvement in overall survival for patients with platinum-resistant ovarian cancer, according to final results from the phase 3 ROSELLA trial. The regimen, which received FDA approval in March 2026, showed a median overall survival gain of 4.1 months compared to nab-paclitaxel alone, regardless of patients' prior taxane exposure.
At a median follow-up of 24.8 months, the relacorilant plus nab-paclitaxel arm (n=188) achieved a median overall survival of 16.0 months, compared to 11.9 months in the nab-paclitaxel monotherapy arm (n=193). The hazard ratio was 0.65 (95% CI, 0.51-0.83; P = .0004), with 76% maturity in the analysis. The trial included 381 patients, nearly all of whom (99.5%) had received at least one prior taxane-containing regimen.
The overall survival benefit was consistent across all prespecified subgroups. Among patients with a taxane-free interval of 6 months or shorter, the hazard ratio was 0.60. For those with a taxane-free interval longer than 6 months, the hazard ratio was 0.66. The benefit was also observed regardless of whether a taxane was used in the most recent prior regimen, with hazard ratios of 0.67 and 0.63, respectively.
Additional efficacy data from the trial showed a statistically significant improvement in progression-free survival. Patients on the combination regimen experienced a 30% reduction in the risk of disease progression or death, with a median progression-free survival of 6.5 months versus 5.5 months for monotherapy (HR, 0.70; P = .008). The 12-month overall survival rates were 60% in the relacorilant arm and 50% in the control arm, while the 18-month rates were 46% and 27%, respectively.
The safety profile was favorable and consistent, with no new safety signals identified in the final analysis. There were no relacorilant-related fatal adverse events and no cases of adrenal insufficiency. The regimen was well-tolerated across both treatment arms.
The ROSELLA trial evaluated relacorilant 150 mg administered orally on the day before, day of, and day after each nab-paclitaxel infusion. Nab-paclitaxel was given at 80 mg/m² intravenously on days 1, 8, and 15 of each 28-day cycle. The control arm received nab-paclitaxel monotherapy at 100 mg/m² on the same schedule. Final overall survival results were also presented at the 2026 SGO Annual Meeting on Women's Cancer and published simultaneously in The Lancet.