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).

作者：Lucy Gilbert, Benoît You, Alexander Babatunde Olawaiye, Chel Hun Choi, Mariana Scaranti, Giorgio Valabrega, John K. Chan, Linda Mileshkin, Toon Van Gorp, Mary Evelyn Gordinier, Cristina Maria Churruca, Carolyn Muller, Laurène Gavoille, Claudia Andreetta, Kofi Agyemang-Prempeh, Andrew R. Clamp, Hristina I. Pashova, Priya Choudhry, María Lapresa, Domenica Lorusso · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.16_suppl.5503 · 被引用次数：2 · 研究领域：Ovarian cancer diagnosis and treatment、Cancer, Stress, Anesthesia, and Immune Response、PARP inhibition in cancer therapy

5503 Background: Relacorilant is a first-in-class, selective glucocorticoid receptor antagonist that increases tumor sensitivity to chemotherapy-induced apoptosis. The phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer (PROC) recently reported statistically significant results for the dual primary endpoints of progression-free survival (PFS) and overall survival (OS). The relacorilant combination was well tolerated and the safety profile was similar to nab-paclitaxel monotherapy. Here we present final OS subgroup analyses for prior taxane use. Methods: Patients (n = 381) were randomized 1:1 to relacorilant (150 mg PO the day before, of, and after nab-paclitaxel) plus nab-paclitaxel (80 mg/m 2 IV on days 1, 8, and 15 of each 28-day cycle) or nab-paclitaxel alone (100 mg/m 2 IV on the same schedule). The final OS analysis was performed after 288 deaths had been reported (76% maturity). The hazard ratio (HR) was estimated with 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. Results: 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 (HR 0.65; 95% confidence interval [CI], 0.51 to 0.83; P = 0.0004). Median OS in the relacorilant combination arm was extended by 4.1 m...