Corcept Therapeutics Incorporated (CORT.US) announced the results of the phase 3 clinical trials of its anti-cancer small molecule, and it is expected to be on the market next year.

Corcept Therapeutics Incorporated (CORT.US) announced that their pivotal Phase 3 clinical trial ROSELLA has achieved the primary endpoint of overall survival (OS). The trial evaluated the efficacy of their selective cortisol modulator relacorilant in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of platinum-resistant ovarian cancer patients. Previously, the U.S. FDA has accepted the marketing application for relacorilant for the treatment of platinum-resistant ovarian cancer and has set a PDUFA date for July 11, 2026. Additionally, the European Medicines Agency (EMA) is also reviewing the marketing authorization application (MAA) for this therapy for the treatment of platinum-resistant ovarian cancer. It is noteworthy that in a recent report released by Clarivate, a renowned industry organization, relacorilant was listed as one of the 11 innovative therapies to watch in 2026. Analysis showed that patients receiving relacorilant in combination with albumin-bound paclitaxel had a 35% reduction in the risk of death compared to those receiving only albumin-bound paclitaxel (HR=0.65, p=0.0004). The median OS for patients receiving relacorilant treatment was 16.0 months, while for patients receiving albumin-bound paclitaxel alone the median OS was 11.9 months, a difference of 4.1 months. The tolerability of relacorilant in combination with albumin-bound paclitaxel treatment was good and consistent with its known safety profile. It is important to note that the type, frequency, and severity of adverse events in the United Therapeutics Corporation group were similar to those in the albumin-bound paclitaxel monotherapy group. Relacorilant provided therapeutic benefits without increasing the safety burden for patients. Corcept had previously announced that the ROSELLA trial also met the primary endpoint of progression-free survival (PFS) improvement, a result confirmed by blinded independent central review (BICR). Compared to patients receiving albumin-bound paclitaxel alone, those receiving relacorilant in combination with United Therapeutics Corporation had a 30% reduction in the risk of disease progression (HR=0.70, p=0.008). Relacorilant is an oral selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to GR without interacting with other hormone receptors in the body. Corcept is advancing the development of relacorilant in ovarian cancer and various other serious diseases, including endogenous Cushing's syndrome, as well as endometrial, cervical, pancreatic, and prostate cancers. The drug has been granted orphan drug designation by the U.S. FDA and the European Commission (EC) for treating Cushing's syndrome and ovarian cancer, respectively.