Relacorilant Plus Nab-Paclitaxel Extends PFS and OS in Ovarian Cancer

The phase 3 ROSELLA study (NCT05257408) has demonstrated that the investigational selective glucocorticoid receptor antagonist (SGRA) relacorilant, when combined with nab-paclitaxel, significantly improves both progression-free survival (PFS) and overall survival (OS) in patients with platinum-resistant ovarian cancer (PROC). This makes it the first regimen to show such a dual benefit compared to a weekly taxane in this patient population.

Here, Alexander Olawaiye, professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at the University of Pittsburgh, discusses the study with Targeted Oncology^TM.

Building on promising phase 2 data, ROSELLA was designed as a randomized, controlled, open-label global study. A total of 381 women with PROC, who had received 1-3 prior lines of therapy and prior bevacizumab, were randomized 1:1 to receive either relacorilant (150 mg the day before, day of, and day after nab-paclitaxel) plus nab-paclitaxel (80 mg/m2) or nab-paclitaxel monotherapy (100 mg/m2). Both regimens involved administration on days 1, 8, and 15 of each 28-day cycle.

The study successfully met its dual primary endpoints. Patients in the relacorilant plus nab-paclitaxel arm experienced a statistically significant improvement in PFS by blinded independent central review (BICR) compared to nab-paclitaxel alone (HR 0.70, 95% CI 0.54-0.91, median 6.5 vs. 5.5 months, P=0.008). A consistent benefit was also observed for PFS by investigator (HR 0.71, P=0.003). Crucially, an interim analysis for OS showed a clinically significant improvement with the addition of relacorilant, with a median OS of 16.0 months compared to 11.5 months for nab-paclitaxel monotherapy (HR 0.69, 95% CI 0.52-0.92, P=0.01). The safety profile was comparable across both arms, with no new safety signals identified. The most common adverse events were consistent with known nab-paclitaxel toxicities, including anemia (58%), neutropenia (56%), and nausea (39%).

These results suggest that relacorilant plus nab-paclitaxel could establish a new standard of care for patients with PROC, offering improved efficacy without requiring biomarker selection.

REFERENCE:

Olawaiye A, Gladieff L, Gilbert L, et al. ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72). J Clin Oncol. 43, LBA5507-LBA5507(2025). DOI:10.1200/JCO.2025.43.17_suppl.LBA5507