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Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer
Data demonstrate a 35 percent reduction in the risk of death Both dual primary endpoints (progression-free and overall survival) were met, without the need
About this update from Corcept Therapeutics Incorporated
[{"type":"text","content":"\n\nData demonstrate a 35 percent reduction in the risk of death\n\n\n\nBoth dual primary endpoints (progression-free and overall survival) were met, without the need for biomarker selection and without increased safety burden\n\n\n\nRelacorilant’s New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) as a treatment for patients with platinum-resistant ovarian cancer with a Prescription Drug User Fee Act (PDUFA) target action date of July 11, 2026\n\n\n\nRelacorilant’s Marketing Authorization Application (MAA) for patients with platinum-resistant ovarian cancer is also under review by the European Medicines Agency (EMA)\n\n\n\n REDWOOD CITY, Calif.--(BUSINESS WIRE)--\nCorcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that ROSELLA, the company’s pivotal Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, met its overall survival (OS) primary endpoint.\n\n\nIn ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004). The median OS for patients receiving relacorilant was 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months. Relacorilant in combination with nab-paclitaxel was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arm were comparable to those in the nab-paclitaxel monotherapy arm. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it.\n\n\nCorcept previously announced that ROSELLA also met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR). Patients who received relacorilant in addition to nab-paclitaxel experienced a 30 percent reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.008). Findings were first presented at ASCO 2025 (American Society ...