Corcept医疗(CORT.US)抗癌小分子关键3期结果公布 有望明年上市

Core Insights - Corcept Medical (CORT.US) announced that its pivotal Phase 3 trial ROSELLA achieved the primary endpoint of overall survival (OS) [1] - The trial evaluated the efficacy of the selective cortisol modulator relacorilant in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer patients [1] - The FDA has accepted the New Drug Application (NDA) for relacorilant, with a PDUFA date set for July 11, 2026, and the EMA is also reviewing the marketing authorization application (MAA) for the same indication [1] Efficacy and Safety - Patients receiving relacorilant in combination with nab-paclitaxel experienced a 35% reduction in the risk of death compared to those receiving nab-paclitaxel alone (HR=0.65, p=0.0004) [1] - The median OS for patients treated with relacorilant was 16.0 months, compared to 11.9 months for those on nab-paclitaxel alone, representing a difference of 4.1 months [1] - The combination treatment demonstrated good tolerability, with adverse events being comparable in type, frequency, and severity to those in the nab-paclitaxel monotherapy group [2] Additional Findings - The ROSELLA trial also met the primary endpoint of progression-free survival (PFS) improvement, confirmed by blinded independent central review (BICR) [2] - Patients receiving the combination therapy had a 30% lower risk of disease progression compared to those receiving nab-paclitaxel alone (HR=0.70, p=0.008) [2] - Relacorilant is an oral selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity without binding to other hormone receptors [2] - Corcept is advancing the development of relacorilant for ovarian cancer and various other serious conditions, including endogenous Cushing's syndrome, endometrial cancer, cervical cancer, pancreatic cancer, and prostate cancer [2] - The drug has received orphan drug designation from the FDA and the European Commission for the treatment of Cushing's syndrome and ovarian cancer [2]