Corcept’s Phase 3 ROSELLA Trial of Relacorilant in Platinum-Resistant Ovarian Cancer Meets Primary Endpoint
Corcept Therapeutics Incorporated (NASDAQ: CORT), a company focused on developing treatments for serious endocrinologic, oncologic, metabolic, and neurologic disorders by modulating cortisol, announced that its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer has successfully met its primary endpoint of improved progression-free survival (PFS), as evaluated by blinded independent central review (PFS-BICR). This milestone marks a significant achievement in the development of novel treatments for ovarian cancer.
The ROSELLA trial demonstrated that patients receiving relacorilant in combination with nab-paclitaxel experienced a 30% reduction in the risk of disease progression compared to those treated with nab-paclitaxel alone. The hazard ratio was 0.70 with a p-value of 0.008. The median PFS for the combination therapy group was 6.5 months, compared to 5.5 months for those receiving nab-paclitaxel alone.
Moreover, in an interim analysis of overall survival (OS), the relacorilant plus nab-paclitaxel group showed a significant improvement, with a median OS of 16.0 months, compared to 11.5 months for the nab-paclitaxel-only group (hazard ratio: 0.69; p-value: 0.012). Importantly, relacorilant was well-tolerated, with no new safety signals observed, and safety and tolerability were similar to the Phase 2 trial, which involved similar patient groups.
The complete results from the ROSELLA trial will be shared at a medical conference later this year. The findings from Corcept’s Phase 2 trial of relacorilant in platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology in June 2023, providing further evidence of the treatment’s potential.
The ROSELLA trial involved 381 patients with platinum-resistant ovarian cancer, enrolling participants from the U.S., Europe, South Korea, Brazil, Argentina, Canada, and Australia. Patients were randomly assigned to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The trial had two primary endpoints: PFS-BICR and OS. The trial was considered successful if either of these endpoints were met, and the combination therapy met both endpoints.
According to Dr. Alexander B. Olawaiye, Director of Gynecological Cancer Research at Magee-Women’s Hospital of the University of Pittsburgh and principal investigator in the ROSELLA trial, the results represent a significant advancement in the treatment of platinum-resistant ovarian cancer. “Patients with advanced ovarian cancer have few good treatment options, and recurrent disease often becomes resistant to existing therapies,” he said. “The ROSELLA results demonstrate that relacorilant combined with nab-paclitaxel could offer an effective new treatment option for these patients.”
Dr. Domenica Lorusso, Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X in Milan and full professor at Humanitas University, also praised the results. “Platinum-resistant ovarian cancer poses a major treatment challenge. The ROSELLA results show that relacorilant, when used in combination with nab-paclitaxel, has the potential to significantly improve patient outcomes.”
Bill Guyer, PharmD, Corcept’s Chief Development Officer, emphasized that the improvement in survival observed in the trial, without increasing the safety burden, brings the company closer to establishing a new standard-of-care treatment for platinum-resistant ovarian cancer. “We are grateful to the patients and investigators who participated in this trial,” said Guyer. “We look forward to presenting the full results and are preparing to submit our New Drug Application (NDA) in the third quarter, with a Marketing Authorization Application (MAA) to follow.”
The ROSELLA trial is being conducted in collaboration with several leading oncology groups, including The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).
About Relacorilant
Relacorilant is an oral therapy developed by Corcept that acts as a selective glucocorticoid receptor (GR) antagonist, modulating cortisol activity by specifically targeting the GR without affecting other hormone receptors in the body. Corcept is studying relacorilant in a variety of serious conditions, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer, in addition to ovarian cancer. Relacorilant is protected by composition of matter, method of use, and other patents, and has received orphan drug designations from both the U.S. FDA and the European Commission for the treatment of hypercortisolism. The European Commission has also granted orphan drug status for the treatment of ovarian cancer.
