ROSELLA: Relacorilant Combination Delays Progression, Extends Survival

For oncology nurses caring for patients with platinum-resistant ovarian cancer (PROC), treatment options have historically been limited and often associated with significant toxicity. However, updated results from the Phase III ROSELLA trial (GOG-3073, ENGOT-ov72) presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting offer a potential new standard of care that balances efficacy with a manageable safety profile.

Lucy Gilbert, MD, Director of Gynecologic Oncology at McGill University and the McGill University Health Centre, reported that the addition of relacorilant — an investigational, oral, selective glucocorticoid receptor antagonist (SGRA) — to nab-paclitaxel significantly improves both progression-free survival (PFS) and overall survival (OS) in this difficult-to-treat population.

Clinical efficacy and survival gains

The ROSELLA trial randomized 381 patients across 170 global sites to receive either the relacorilant combination or nab-paclitaxel monotherapy. Patients in the combination arm received 150 mg of relacorilant the day before, day of, and day after nab-paclitaxel (80 mg/m² on days 1, 8, and 15 of a 28-day cycle).

The trial met its primary endpoint, showing a statistically significant improvement in PFS (6.5 vs. 5.5 months; HR 0.70). More importantly for clinical practice, an interim analysis revealed a clinically significant OS benefit, with a median of 16.0 months for the combination versus 11.5 months for monotherapy. Gilbert emphasized that this represents a 35% reduction in the risk of death, a major milestone for patients who often have very poor prognoses.

Managing toxicities

For the nursing team, understanding and managing the side effect profile is critical to maintaining patient adherence. The trial found that adverse events (AEs) were generally comparable across both arms, and relacorilant did not introduce new safety signals. The most frequent AEs were typical of nab-paclitaxel:

• Anemia (58%)
• Neutropenia (56%)
• Nausea (39%)

Gilbert provided important biological context for these hematologic effects. While anemia and neutropenia were slightly higher in the relacorilant arm, she noted this was largely because patients remained on the treatment significantly longer due to its efficacy. Furthermore, relacorilant may have a synergistic effect with chemotherapy on myeloid cells, increasing apoptosis. Regarding anemia, she explained that glucocorticoid receptors act on erythroid progenitor cells, which may contribute to the slightly higher association with this AE.

Practical implementation

From a workflow perspective, a key advantage of this regimen is that it does not require biomarker selection, allowing it to be implemented broadly across the PROC population. Despite the slightly higher rates of some AEs, discontinuation rates remained comparable between the two arms, suggesting the regimen is tolerable for patients in a real-world setting.

Gilbert concluded that for patients who "consider death as the ultimate toxicity," the gain of over four months in median survival with minimal added toxicity is "immensely encouraging." For oncology nurses, these data support relacorilant plus nab-paclitaxel as a vital new tool for extending life while preserving the patient’s ability to remain on therapy.

Reference

1. 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. 2025;43(suppl 17; abstr LBA5507). doi:10.1200/JCO.2025.43.17_suppl.LBA5507