What's Happening?
Corcept Therapeutics has announced that its Phase 3 ROSELLA trial for relacorilant, in combination with nab-paclitaxel, has met its primary endpoint of overall survival in patients with platinum-resistant
ovarian cancer. The trial demonstrated a 35% reduction in the risk of death compared to nab-paclitaxel alone, with a median overall survival of 16 months versus 11.9 months. The treatment was well-tolerated, with adverse events comparable to the monotherapy. The trial results were first presented at ASCO 2025 and published in The Lancet. Relacorilant's New Drug Application is under review by the FDA, with a decision expected by July 11, 2026.
Why It's Important?
The success of the ROSELLA trial is significant as it offers a potential new standard-of-care for patients with platinum-resistant ovarian cancer, a group with limited treatment options. The combination of relacorilant and nab-paclitaxel could extend survival and improve quality of life without increasing safety risks. This development could influence treatment protocols and provide a new therapeutic option for oncologists. The trial's success also highlights the potential of cortisol modulation in oncology, which could lead to further research and applications in other cancer types.
What's Next?
Corcept is working with regulatory authorities in the U.S. and Europe to expedite the approval process for relacorilant. The company is also exploring the use of relacorilant in earlier stages of ovarian cancer and other tumors expressing the glucocorticoid receptor. The complete results of the ROSELLA trial will be presented at an upcoming medical conference, which could further validate the findings and influence clinical practice.
