Phase 3 ROSELLA trial shows relacorilant plus nab-paclitaxel reduced death risk by 35% and improved survival in platinum-resistant ovarian cancer, with comparable safety.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Corcept Therapeutics reported final overall survival results from the Phase 3 ROSELLA trial (NCT05257408) evaluating relacorilant (Lifyorli) plus nab-paclitaxel in patients with platinum-resistant ovarian cancer. The data were presented at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting and simultaneously published in The Lancet.
Phase 3 ROSELLA Results
The randomized trial enrolled 381 patients assigned to relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The study met dual primary endpoints of overall survival and progression-free survival.
The combination reduced the risk of death by 35% compared with chemotherapy alone (hazard ratio 0.65; p=0.0004). Median overall survival improved to 16.0 months versus 11.9 months with nab-paclitaxel alone. The regimen also reduced the risk of disease progression by 30% (hazard ratio 0.70; p=0.0076).
Safety
Adverse events with relacorilant plus nab-paclitaxel were comparable to nab-paclitaxel alone. Warnings include neutropenia, severe infections, adrenal insufficiency, exacerbation of glucocorticoid-treated conditions, and embryo-fetal toxicity. Common adverse reactions (>20%) included decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
Investigator and Company Comments
Alexander B. Olawaiye, M.D., principal investigator in the ROSELLA trial, said the results demonstrate meaningful efficacy and safety, positioning relacorilant plus nab-paclitaxel as a new preferred option in platinum-resistant ovarian cancer.
Domenica Lorusso, M.D., Ph.D., an investigator in the ROSELLA trial, stated the regimen significantly extends overall survival with minimal added toxicity and is emerging as a new standard-of-care, with European approval anticipated.
Bill Guyer, PharmD, Corcept’s Chief Development Officer, said the findings support selective glucocorticoid receptor antagonists such as relacorilant, with the company focused on delivering the therapy and expanding research across glucocorticoid receptor–expressing tumors.
Mechanism
Relacorilant is an oral selective glucocorticoid receptor antagonist administered around each nab-paclitaxel cycle to enhance chemotherapy sensitivity by blocking cortisol signaling.
Regulatory and Development Outlook
Relacorilant has received U.S. FDA approval and has been added to NCCN Guidelines as a preferred regimen. Corcept has submitted a Marketing Authorisation Application to the European Medicines Agency and is evaluating relacorilant in additional tumor types, including endometrial, cervical, pancreatic, and prostate cancers.
References
Corcept Presents Complete Data from Pivotal ROSELLA Trial in SGO Late-Breaker with Simultaneous Publication in The Lancet: Lifyorli™ (Relacorilant) Plus Nab-Paclitaxel Improves Overall Survival in Patients with Platinum-Resistant Ovarian Cancer, 10 April 2026, https://ir.corcept.com/news-releases/news-release-details/corcept-presents-complete-data-pivotal-rosella-trial-sgo-late
Domenica Lorusso et al, Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial, Published April 10, 2026, The Lancet, https://doi.org/10.1016/S0140-6736(26)00462-9
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://clinicaltrials.gov/study/NCT05257408
About Writer
Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.