Corcept Therapeutics stock soars after successful Phase 3 trial

Investing.com -- Shares of Corcept Therapeutics (NASDAQ:CORT) Incorporated (NASDAQ: CORT) surged 90% following the announcement of positive results from its pivotal Phase 3 ROSELLA trial. The study evaluated relacorilant in combination with nab-paclitaxel for patients with platinum-resistant ovarian cancer and met its primary endpoint.

The trial demonstrated that the combination therapy led to a 30% reduction in the risk of disease progression and an improvement in overall survival. Specifically, patients receiving relacorilant plus nab-paclitaxel showed a median progression-free survival (PFS) of 6.5 months versus 5.5 months for those treated with nab-paclitaxel alone. The interim evaluation revealed a median overall survival (OS) of 16.0 months compared to 11.5 months in the control group. These findings, along with a favorable safety profile, are expected to support New Drug Application (NDA) submissions in the United States and Marketing Authorization Applications (MAA) in Europe.

The company’s Chief Development Officer, Bill Guyer, PharmD, expressed optimism about the potential for relacorilant to establish a new standard of care for this challenging form of ovarian cancer. Corcept plans to submit the NDA in the third quarter and the MAA shortly thereafter, aiming to address the significant need for effective treatments in this patient population.

The ROSELLA trial’s success is particularly notable as it did not require biomarker selection for patient enrollment, which could imply broader applicability of the treatment. The trial involved 381 patients across multiple international sites, reflecting a comprehensive and diverse study group. The dual primary endpoints of PFS and OS were both met, indicating a significant advancement in the treatment landscape for platinum-resistant ovarian cancer.

Medical (TASE:BLWV) professionals involved in the trial, including Alexander B. Olawaiye, M.D., and Domenica Lorusso, M.D., Ph.D., highlighted the importance of these findings for patients with advanced ovarian cancer, especially considering the limited treatment options currently available for those with recurrent disease.

The full results of the ROSELLA trial are scheduled to be presented at a medical conference this year, with previous Phase 2 trial results already published in the Journal of Clinical Oncology in June 2023. Corcept’s collaboration with various oncological trial groups underscores the global importance of this development and the potential impact of relacorilant on patient outcomes worldwide.

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