Key Clinical Summary: 

• Design/Population: The phase 3 ROSELLA trial randomized 381 patients with platinum-resistant ovarian cancer to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone. Dual primary end points were progression-free survival and overall survival.
• Key Outcomes: The combination significantly improved overall survival, with a 35% reduction in risk of death and a median overall survival benefit of 4.1 months. Safety was manageable and consistent with known chemotherapy-related toxicities.
• Clinical Relevance: Relacorilant plus nab-paclitaxel represents a promising new treatment option in platinum-resistant ovarian cancer without the need for biomarker selection. These findings support its potential adoption as a new standard of care.

According to final overall survival (OS) results from the phase 3 ROSELLA trial, the addition of relacorilant, a first-in-class, selective glucocorticoid receptor antagonist, to nab-paclitaxel significantly improved survival compared with nab-paclitaxel alone among patients with platinum-resistant ovarian cancer.

These findings were presented by Alexander Olawaiye, MD, University of Pittsburgh, Pittsburgh, Pennsylvania, at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting in San Juan, Puerto Rico.

In this study, 381 patients were randomized 1:1 to receive either 150 mg of relacorilant (on the day before, the day of, and the day after nab-paclitaxel) plus 80 mg/m² of nab-paclitaxel (on days 1, 8, and 15) or 100 mg/m² of nab-paclitaxel monotherapy (on days 1, 8, and 15) in 28 day cycles. The primary end points included progression-free survival (PFS) and OS. A key secondary end point was safety.

At a median follow-up of 24.8 months, the addition of relacorilant reduced the risk of death from any cause by 35% (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.51 to 0.83; P = .0004). Median OS was 16 months in the relacorilant plus nab-paclitaxel arm and 11.9 months in the nab-paclitaxel monotherapy arm. At 18 months, the probability of survival was 46% and 27%, respectively. OS analyses consistently favored relacorilant plus nab-paclitaxel across all subgroups.

Safety was consistent with prior findings and no new safety signals were identified. The most frequently reported adverse events included anemia, neutropenia, fatigue, and nausea. 

“Relacorilant plus nab-paclitaxel demonstrated a statistically and clinically significant OS benefit in patients with [platinum-resistant ovarian cancer] compared to a weekly taxane, the most efficacious chemotherapy,” concluded Dr Olawaiye. “These outcomes position relacorilant plus nab-paclitaxel as a new standard treatment option for patients with [platinum-resistant ovarian cancer], without the need for biomarker selection.” 

Source: 

Olawaiye A, Quesada S, Gilbert L, et al. Final overall survival (OS) results from the phase 3 ROSELLA trial: Relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (PROC) (GOG-3073, ENGOT-ov72, APGOT-Ov10, and LACOG-0223). Presented at SGO Annual Meeting on Women’s Cancer. April 10 - 13, 2026; San Juan, Puerto Rico. LBA1.