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The phase 3 trial showed relacorilant with chemotherapy improved progression-free and overall survival in platinum-resistant ovarian cancer.
The primary end goal was met in a phase 3 trial of relacorilant plus nab-paclitaxel chemotherapy in patients with platinum resistant ovarian cancer, which improved progression-free survival, according to the drug’s manufacturer, Corcept Therapeutics Inc.
Recent findings that supported this decision come from the phase 3 trial ROSELLA.
“Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies,” Dr. Alexander B. Olawaiye said in the news release. “The ROSELLA results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer.”
Olawaiye is the Director of gynecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh and Principal Investigator in the ROSELLA trial.
In the ROSELLA trial, patients treated with relacorilant plus nab-paclitaxel had a 30% lower risk of disease progression than those receiving nab-paclitaxel alone. Median progression-free survival by blinded independent central review was 6.5 months versus 5.5 months, respectively. An interim overall survival analysis showed a significant improvement with relacorilant, with a median of 16 months compared with 11.5 months for nab-paclitaxel alone.
Overall survival: the time from treatment initiation until death from any cause.
Progression-free survival: the time at which half of the patients in a clinical trial experience disease progression or death.
Orphan drug designation: a status granted by regulatory agencies to drugs developed for rare diseases, providing benefits like market exclusivity and tax credits.
Regarding safety, relacorilant was well tolerated, with no new safety signals. Safety and tolerability were consistent between groups, as seen in the company’s phase 2 trial.
Full results will be presented at a medical conference this year. Findings from Corcept’s phase 2 trial in platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology in June 2023.
“Platinum-resistant ovarian cancer poses a significant treatment challenge. The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes,” Dr. Domenica Lorusso, Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano and investigator in the ROSELLA trial, said in the news release.
The ROSELLA trial enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Biomarker selection was not required. Patients were randomly assigned to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.
The trial has dual primary end goals: progression-free survival by blinded independent central review and overall survival. A positive outcome is achieved if either end goal is met.
Relacorilant is an oral therapy and a selective glucocorticoid receptor antagonist that modulates cortisol activity by binding to the glucocorticoid receptor without affecting other hormone receptors, as per the release. Corcept is studying relacorilant for ovarian cancer and other serious conditions, including endogenous hypercortisolism, also known as Cushing’s syndrome, and prostate cancer.
Relacorilant has been designated an orphan drug by the Food and Drug Administration and the European Commission for the treatment of hypercortisolism and by the European Commission for ovarian cancer.
“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” Bill Guyer, Corcept’s Chief Development Officer, said in the news release. “We deeply appreciate the patients and investigators who participated in the trial, and we look forward to presenting the trial’s full results in the coming months. We expect to submit our [new drug application] in the third quarter and our [Marketing Authorization Application] shortly thereafter.”
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