Relacorilant + Nab-Paclitaxel Beneficial in Ovarian Cancer
METHODOLOGY:
While platinum-based chemotherapy is initially effective, about 70% of patients experience disease relapse that becomes platinum-resistant.
Relacorilant, a selective glucocorticoid receptor antagonist, has demonstrated synergy with paclitaxel in nonclinical tumor models. The combination with nab-paclitaxel was chosen for this study because it does not require corticosteroid coadministration.
Researchers conducted a randomized, controlled, open-label, phase 3 trial (ROSELLA [GOG-3073/ENGOT-ov72]) at 117 hospitals and community oncology treatment centers across 14 countries in Australia, Europe, Latin America, North America, and South Korea.
Participants included 381 patients aged 18 years or older with confirmed platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer; up to three previous lines of anticancer therapy; and measurable disease as per Response Evaluation Criteria in Solid Tumors (version 1.1).
Analysis involved comparing relacorilant (150 mg orally the day before, of, and after nab-paclitaxel infusion) plus nab-paclitaxel (80 mg/m2 intravenously on days 1, 8, and 15 of each 28-day cycle) with nab-paclitaxel monotherapy (100 mg/m2 on the same schedule).
TAKEAWAY:
Patients receiving relacorilant plus nab-paclitaxel showed improved progression-free survival compared with those receiving nab-paclitaxel monotherapy (hazard ratio [HR], 0.70; 95% CI, 0.54-0.91; median, 6.54 months vs 5.52 months; stratified log-rank P = .0076).
= .0076). Interim analysis revealed improved overall survival with relacorilant plus nab-paclitaxel vs nab-paclitaxel monotherapy (HR, 0.69; 95% CI, 0.52-0.92; median, 15.97 months vs 11.50 months; log-rank P = .0121).
= .0121). Safety profiles were comparable between the groups when adjusted for nab-paclitaxel exposure, with no new safety signals observed.
IN PRACTICE:
'Combined with the evidence from previous studies, our study supports relacorilant plus nab-paclitaxel as a potential new standard of care for patients with platinum-resistant ovarian cancer, without the need for biomarker selection. This study is the first positive clinical trial conducted with registrational intent for a selective glucocorticoid receptor antagonist in patients with cancer,' authors of the study wrote.
SOURCE:
Lead author Alexander B. Olawaiye, MD, of the University of Pittsburgh School of Medicine and UPMC Magee-Womens Hospital, both in Pittsburgh, presented the results of the study at American Society of Clinical Oncology (ASCO) 2025. A paper on the study was published online in The Lancet on June 2.
LIMITATIONS:
The open-label design and applicability to patients with more than three lines of anticancer therapy were noted as limitations. While the risk of bias in progression-free survival assessment was mitigated by using blinded independent central review and a dual primary endpoint of overall survival, the median duration of the follow-up for overall survival was less than the estimated median overall survival in the relacorilant combination group at interim analysis.
DISCLOSURES:
The study was funded by Corcept Therapeutics. The authors reported that adverse events were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 5.0), with relatedness determined by the investigators. The funding source supported trial conduct, patient enrollment, and drug supply. The analysis, interpretation, writing, and submission decisions were the responsibility of the authors.
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