Combo treatment new SOC in platinum-resistant ovarian cancer
Corcept Therapeutics has shared final overall survival data from its pivotal Phase III ROSELLA trial of Lifyorli (relacorilant) combined with the chemotherapeutic agent nab-paclitaxel in patients with platinum-resistant ovarian cancer.
The results were shared in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women’s Cancer and simultaneously published in The Lancet.
Lifyorli plus nab-paclitaxel has now been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen for patients with platinum-resistant ovarian cancer.
Lifyorli, in combination with nab-paclitaxel, was approved by the US Food and Drug Administration (FDA) in March 2026 for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
“Patients with platinum-resistant ovarian cancer need more good treatment options. Relacorilant provides one. It significantly extends overall survival, with very little added toxicity,” said Domenica Lorusso, Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X in Milan, and Full Professor of Obstetrics and Gynaecology at Humanitas University, Pieve Emanuele, Lancet publication senior author and European Network of Gynaecological Oncological Trial groups (ENGOT) investigator in the ROSELLA trial. “This regimen is firmly positioned as a new standard-of-care treatment for patients in the United States. We anticipate regulatory approval in Europe soon.”
The ROSELLA Phase III trial
The ROSELLA trial met its dual primary endpoints of overall and progression-free survival, regardless of biomarker status and without an increased safety burden. Patients treated with Lifyorli in addition to nab-paclitaxel chemotherapy experienced a 35% reduction in the risk of death compared to patients treated with nab-paclitaxel alone.
Median overall survival was 4.1 months longer for patients who received Lifyorli, compared to patients receiving nab-paclitaxel alone (16.0 vs. 11.9 months). Patients who received Lifyorli in addition to nab-paclitaxel also experienced a 30% reduction in the risk of disease progression, as assessed by blinded independent central review compared to patients treated with nab-paclitaxel alone.
The prescribing information for Lifyorli includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-foetal toxicity.
“The safety and efficacy findings from ROSELLA are remarkable,” said Alexander Olawaiye, Professor and Vice Chair of Diversity and Inclusion at Magee-Women’s Hospital of the University of Pittsburgh, Principal Investigator in the ROSELLA trial, SGO presenter and Lancet publication author. “They give hope to patients and oncologists now that we have a new preferred regimen in this devastating and difficult-to-treat cancer.”
