Relacorilant Maintains OS Benefit in Ovarian Cancer Despite Prior Taxane Use

Findings from the phase 3 ROSELLA trial (NCT05257408) showed an improved overall survival (OS) benefit with relacorilant (Lifyorli) plus nab-paclitaxel (Abraxane) for patients with platinum-resistant ovarian cancer, which was consistent across all prior taxane exposure histories.

At a median follow-up of 24.8 months, the addition of relacorilant to nab-paclitaxel resulted in a statistically and clinically significant improvement in OS across all 381 patients (HR, 0.65; 95% CI, 0.51-0.83; P = .0004; 76% maturity), with the median OS of 16.0 months (95% CI, 13.0-18.3) in the relacorilant arm (n = 188; events, 129 [69%]) versus 11.9 months (95% CI, 10.0-13.8) in the nab-paclitaxel monotherapy arm (n = 193; events, 159 [82%]).1 Prior taxane use was almost universal: 379 of 381 patients (99.5%) had received at least one prior taxane-containing regimen.

The OS benefit was consistent irrespective of the taxane-free interval. Among patients with a taxane-free interval of 6 months or fewer (n = 55), the relacorilant arm (n = 22) had a median OS of 16.7 months (95% CI, 7.9-18.7) versus 11.0 months (95% CI, 7.6-13.3) in the nab-paclitaxel monotherapy arm (n = 33), corresponding to an HR of 0.60 (95% CI, 0.31-1.15). Among patients with a taxane-free interval greater than 6 months (n = 324), the relacorilant arm (n = 165) had a median OS of 15.7 months (95% CI, 12.4-19.3) versus 12.1 months (95% CI, 9.8-14.3) in the monotherapy arm (n = 159), with an HR of 0.66 (95% CI, 0.51-0.86).¹

The benefit was also consistent regardless of whether a taxane was used in the most recent prior regimen. In patients whose most recent regimen included a taxane, the HR was 0.67 (95% CI, 0.38-1.19). In patients who had not received a taxane in their last regimen, the HR was 0.63 (95% CI, 0.48-0.82).¹

“Overall survival favored the relacorilant combination arm across all prespecified subgroups, including participants with a short taxane-free interval and with taxane use in the most recent regimen,” lead author Lucy Gilbert, MD, MSc, FRCOG, of the Division of Gynecologic Oncology at McGill University Health Centre in Montreal, Quebec, said when presenting the findings at ASCO. “A clinically significant median overall survival improvement of 4.1 months positions relacorilant plus nab-paclitaxel as a new treatment option for patients without the need for biomarker selection,” added Gilbert.

Safety of Relacorilant

Gilbert reported at ASCO that relacorilant plus nab-paclitaxel was well-tolerated, with a favorable and consistent safety profile. There were no new safety signals that emerged with additional follow-up compared with what had previously been reported. Gilbert emphasized that, “There were no relacorilant-related fatal adverse events and no cases of adrenal insufficiency.”

Design and Details of ROSELLA Subgroup Analysis

The analysis included all 381 patients enrolled in ROSELLA, who were randomized 1:1 to relacorilant 150 mg orally on the day before, day of, and day after each nab-paclitaxel infusion (80 mg/m² intravenously on days 1, 8, and 15 of each 28-day cycle) or nab-paclitaxel monotherapy (100 mg/m² on the same schedule). The HR was estimated using a Cox regression model with treatment group as the main effect and stratification factors at randomization as covariates. Kaplan-Meier methods were used to estimate medians and generate survival curves.

Final ROSELLA OS Results From SGO 2026

The ASCO 2026 subgroup data build on the final OS analysis of ROSELLA presented at the 2026 SGO Annual Meeting on Women's Cancer, with simultaneous publication in The Lancet.^2,3 Those data represented the primary basis for the FDA approval of relacorilant in March 2026.⁴

Additional efficacy data shared at the SGO meeting included 12-month OS rates of 60% and 50%, and 18-month OS rates of 46% and 27%, respectively, for the treatment and control arms.3 OS data favored the relacorilant combination across all prespecified subgroups, including prior lines of therapy—2 prior lines (HR, 0.68; 95% CI, 0.48-0.96) and 3 prior lines (HR, 0.60; 95% CI, 0.41-0.86)—prior PARP inhibitor exposure (yes: HR, 0.70; 95% CI, 0.51-0.95; no: HR, 0.67; 95% CI, 0.46-0.98), and primary platinum-free interval length (≤6 months: HR, 0.61).²

ROSELLA also met its co-primary PFS endpoint, with patients receiving relacorilant plus nab-paclitaxel experiencing a 30% reduction in the risk of disease progression or death compared with nab-paclitaxel alone (HR, 0.70; 95% CI, 0.54-0.91; median PFS, 6.5 vs 5.5 months; P = .008).³ The safety profile was comparable across both arms with no new safety signals identified.

References

1. Gilbert L, Quesada S, Olawaiye AB, et al. Overall survival subgroup analyses for prior taxane use in the phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72, APGOT-Ov10, LACOG-0223, and ANZGOG-2221/2023). J Clin Oncol. 2026;44(suppl 16):abstr 5503. Presented at: 2026 ASCO Annual Meeting; May 29-June 2, 2026; Chicago, IL.

2. Olawaiye AB, Quesada S, Gilbert L, et al. Final overall survival results from the phase 3 ROSELLA trial: relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer. Presented at: 2026 SGO Annual Meeting on Women's Cancer; April 10-13, 2026; San Juan, Puerto Rico. Abstract LBA01.

3. Lorusso D, Gladieff L, Gilbert L, et al. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial. Lancet. 2026;407:1513-1524. doi:10.1016/S0140-6736(26)00462-9

4. US Food and Drug Administration. FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. March 25, 2026. Accessed May 29, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or