Corcept reports positive Phase 3 ROSELLA trial results showing relacorilant plus nab-paclitaxel significantly improved overall and progression-free survival in patients with platinum-resistant ovarian cancer.
Written By: Pharmacally Medical News Desk
Corcept Therapeutics has reported positive and practice-shaping results from ROSELLA, its pivotal Phase 3 trial evaluating relacorilant in combination with nab-paclitaxel for patients with platinum-resistant ovarian cancer. The study met its primary endpoint of overall survival, marking a meaningful advance in a setting where treatment options are limited and outcomes remain poor.
Dr. Bill Guyer, Chief Development Officer, Corcept expressed gratitude to the patients and investigators involved in the ROSELLA trial and stated that Corcept is actively working with U.S. and European regulatory authorities to make relacorilant available to patients as quickly as possible.
Clear Overall Survival Advantage
In ROSELLA, adding relacorilant to nab-paclitaxel reduced the risk of death by 35% compared with chemotherapy alone (hazard ratio 0.65). Median overall survival reached 16 months in the combination arm versus 11.9 months with nab-paclitaxel alone, translating into a 4.1-month improvement.
These results are notable not only for their statistical strength, but also for their clinical relevance in a population that has historically seen only modest survival gains from available therapies.
Progression-Free Survival Also Improved
Corcept previously disclosed that ROSELLA met its progression-free survival endpoint as assessed by blinded independent central review. Patients receiving relacorilant plus nab-paclitaxel experienced a 30% reduction in the risk of disease progression (hazard ratio 0.70). The findings were first presented at American Society of Clinical Oncology 2025 and published simultaneously in The Lancet. Full data will be shared at an upcoming medical meeting.
Favorable Safety Profile Without Added Burden
The survival benefit was achieved without increasing toxicity. Relacorilant was well tolerated, and the type, frequency, and severity of adverse events in the combination arm were comparable to those seen with nab-paclitaxel alone. This suggests that relacorilant enhances chemotherapy effectiveness without adding a new safety burden, a critical consideration in heavily pretreated patients.
ROSELLA Trial
ROSELLA (NCT05257408) enrolled 381 patients across the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia. Participants were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The study was conducted in collaboration with multiple international cooperative groups, including GOG-F, ENGOT, APGOT, LACOG, and ANZGOG, underscoring the global relevance of the results.
Dr. Alexander B. Olawaiye, principal Investigator in the ROSELLA trial highlighted that relacorilant plus nab-paclitaxel has the potential to become a new standard of care in platinum-resistant ovarian cancer due to its overall survival benefit, good tolerability, oral dosing, and lack of biomarker restrictions. He also noted that the ROSELLA results support further evaluation of relacorilant in earlier-stage ovarian cancer and other glucocorticoid receptor–expressing tumors, including endometrial and cervical cancers.
Dr. Domenica Lorusso, another investigator in the ROSELLA trial emphasized that the ROSELLA data demonstrate meaningful improvements in both overall and progression-free survival in patients with advanced, recurrent ovarian cancer. She underscored the clinical importance of introducing relacorilant plus nab-paclitaxel as a new option for tumors that have become resistant to standard chemotherapy.
Regulatory Path and Future Development
Relacorilant is an oral, selective glucocorticoid receptor antagonist designed to block the harmful effects of cortisol in cancer. By binding to the glucocorticoid receptor without activating it, relacorilant prevents cortisol-driven signalling that promotes tumor survival, chemotherapy resistance, and immune suppression.
Relacorilant has received orphan drug designation for hypercortisolism and ovarian cancer in Europe, and for hypercortisolism in the United States. The U.S. FDA has set a PDUFA date of July 11, 2026 for relacorilant in platinum-resistant ovarian cancer, and a Marketing Authorization Application is under review by the European Medicines Agency.
Beyond ROSELLA, Corcept is studying relacorilant in other solid tumors, including platinum-sensitive ovarian, endometrial, cervical, pancreatic, and prostate cancers. Investigators have also highlighted the rationale for exploring its use in earlier stages of ovarian cancer.
References
Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer, 22 January 2026, Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer – Corcept Therapeutics, Incorporated
Relacorilant in Combination with Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer, ClinicalTrials.gov ID NCT05257408, https://www.clinicaltrials.gov/study/NCT05257408
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), Meeting Abstract: 2025 ASCO Annual Meeting II, https://ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA5507
Olawaiye, Alexander B et al., Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial, The Lancet, Volume 405, Issue 10496, 2205 – 2216, https://doi.org/10.1016/S0140-6736(25)01040-2