Phase 3 Rosella Trial Enrollment Complete for Relacorilant in Platinum-Resistant Ovarian Cancer

Corcept Therapeutics Incorporated, a pharmaceutical company specializing in the development of treatments for serious medical conditions, has announced the completion of patient enrollment in a significant Phase 3 trial. The trial, known as ROSELLA, is testing the efficacy of relacorilant, a selective cortisol modulator, in conjunction with nab-paclitaxel for the treatment of patients with recurrent platinum-resistant ovarian cancer.

The Chief Development Officer of Corcept, Bill Guyer, has highlighted the importance of this milestone, stating that it brings the company closer to fulfilling a significant medical need for women suffering from this type of cancer. He expressed optimism that relacorilant could become a standard treatment for the disease and anticipates the release of progression-free survival data, which is the primary endpoint of the ROSELLA trial, by the year's end.

The design of the ROSELLA trial mirrors a previous successful Phase 2 study, where patients who received relacorilant intermittently showed improved outcomes in terms of progression-free survival, response duration, and overall survival, compared to those who received only nab-paclitaxel. These findings were published in a renowned medical journal in June 2023.

The trial involved 381 female participants from various sites across the globe, including the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia. Participants were randomly assigned to either receive relacorilant with nab-paclitaxel or nab-paclitaxel alone. The primary focus of the trial is on progression-free survival, with overall survival being a crucial secondary endpoint.

Platinum-resistant ovarian cancer is a severe condition, being the fifth leading cause of cancer-related deaths among women. Patients who experience a recurrence of the disease within six months of receiving platinum-based therapy are classified as having platinum-resistant disease. The current treatment options are limited, and the median overall survival post-recurrence is typically 12 months or less with single-agent chemotherapy. In the United States, it is estimated that around 20,000 women with this condition are in need of new therapies each year.

Relacorilant operates by selectively binding to the glucocorticoid receptor without interacting with other hormone receptors in the body. Corcept is exploring its potential in treating a range of serious disorders, including different types of cancer and Cushing’s syndrome. The compound is proprietary to Corcept and is protected by various patents.

Cortisol's role in allowing certain solid tumors to resist treatment is well-documented. It can inhibit the apoptosis process, which is essential for many cancer treatments, and also promote tumor growth. Furthermore, cortisol can suppress the immune system, making it more challenging for the body to combat cancer. By modulating cortisol's activity, it may be possible to reduce these negative effects and enhance the effectiveness of anti-cancer treatments.

Corcept has been conducting clinical trials with relacorilant combined with different anti-cancer therapies for ovarian, adrenal, and prostate cancers. With over 25 years of experience in cortisol modulation, Corcept has discovered numerous selective cortisol modulators and is conducting advanced clinical trials for various serious disorders, including hypercortisolism, solid tumors, ALS, and liver disease. The company also markets Korlym, the first FDA-approved medication for Cushing’s syndrome, from its headquarters in Menlo Park, California.