Corcept Completes Enrollment in Phase III Ovarian Cancer Study of Relacorilant
核心洞察
Corcept Therapeutics has completed enrollment in the Phase III ROSELLA study evaluating relacorilant plus Abraxane for recurrent, platinum-resistant ovarian cancer (搜索).
The primary endpoint of the ROSELLA study is progression-free survival, with overall survival as a key secondary endpoint; data is expected by late 2024.
Relacorilant is also being evaluated in Phase III trials for Cushing's syndrome and in combination with Keytruda for adrenal cancer (搜索), with data readouts expected in 2024.
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 (搜索). 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 (搜索), 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 (搜索), 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 (搜索)’s Keytruda (pembrolizumab) for patients with adrenal cancer (搜索) 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 (搜索) is a significant cause of mortality in women's cancers, and new treatment options are needed, especially for those with recurrent, platinum-resistant disease.