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Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Wednesday, July 9, 2025
Relacorilant in combination with nab-paclitaxel demonstrated improvement in both progression-free survival and overall survival in patients with platinumresistant ovarian cancer compared with weekly nab-paclitaxel monotherapy according to findings from the phase III ROSELLA trial.
The study authors noted that this was the first treatment regimen to show a survival benefit compared with taxanes alone for this patient population. Findings were presented during the 2025 ASCO Annual Meeting (Abstract LBA5507) and published in The Lancet.
Eligible patients had platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer and were treated with up to three prior lines of treatment including prior bevacizumab with disease progression or intolerance to the most recent treatment. They were randomized to receive either relacorilant and nab-paclitaxel (n = 188) or nab-paclitaxel monotherapy (n = 193).
The combination regimen led to a statistically significant improvement in progression-free survival of 6.54 months compared with 5.52 months with nab-paclitaxel alone (hazard ratio [HR] = 0.70; 95% confidence interval [CI] = 0.54–0.91; stratified log-rank P = .0076).
In the interim analysis a trend toward improved overall survival was also seen with the addition of relacorilant with a median overall survival of 15.97 months with the combination regimen compared with 11.50 months with nab-paclitaxel alone (HR = 0.69; 95% CI = 0.52–0.92; log-rank P = .0121).
When adjusted for nab-paclitaxel exposure, adverse events were similar between the two cohorts and no new safety signals were observed. The most common adverse events were all known toxicities associated with nab-paclitaxel, including anemia, neutropenia, and nausea.
“It is a well-tolerated regimen and we believe it should be a new standard for platinum-resistant ovarian cancer therapy,” said lead study author Alexander B. Olawaiye, MD, FACOG, FACS, Principal Investigator, Gynecologic Oncology Group, University of Pittsburgh Cancer Institute, and Director of Gynecologic Cancer Research, University of Pittsburgh School of Medicine and Magee-Women's Hospital, Pennsylvania.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
