Corcept Therapeutics has announced the completion of enrollment in its Phase III ROSELLA study. This trial is evaluating relacorilant in combination with Abraxane (nab-paclitaxel) for the treatment of patients with recurrent, platinum-resistant ovarian cancer. The study aims to improve outcomes for patients with this challenging disease.
The ROSELLA study's primary endpoint is progression-free survival (PFS), a critical measure of treatment efficacy in cancer trials. Overall survival (OS) is a key secondary endpoint. Data from the ROSELLA study is anticipated by the end of 2024. A prior Phase II study suggested that intermittent dosing of relacorilant—the day before, the day of, and the day after nab-paclitaxel administration—led to improvements in PFS, duration of response, and OS compared to nab-paclitaxel alone. The ROSELLA study mirrors this Phase II design.
Beyond ovarian cancer, Corcept is also investigating relacorilant in other clinical trials. The GRACE study, a Phase III trial, is evaluating relacorilant for the treatment of Cushing’s syndrome, with a new drug application expected in the second quarter of 2024. Additionally, the Phase III GRADIENT study is assessing relacorilant in patients with Cushing’s syndrome caused by adrenal adenoma; enrollment in this study has also been completed, with data expected in the fourth quarter of 2024. Furthermore, a Phase Ib study is examining relacorilant in combination with Merck’s Keytruda (pembrolizumab) for patients with adrenal cancer and cortisol excess; data from this study is expected in mid-2024.
Relacorilant is a selective cortisol modulator. Cortisol plays a role in cancer biology, and modulating its activity could potentially enhance the effectiveness of cancer treatments. The rationale behind combining relacorilant with Abraxane is to mitigate cortisol-mediated resistance to chemotherapy and improve patient outcomes. Ovarian cancer is a significant cause of mortality in women's cancers, and new treatment options are needed, especially for those with recurrent, platinum-resistant disease.
