Corcept Therapeutics (CORT.US) announced that its pivotal Phase 3 clinical trial, ROSELLA, has met its primary endpoint of Overall Survival (OS). The trial evaluated the efficacy of its selective cortisol modulator, relacorilant, in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer. Previously, the U.S. FDA accepted the New Drug Application for relacorilant for this indication and set a PDUFA target action date for July 11, 2026. Separately, the European Medicines Agency (EMA) is also reviewing the Marketing Authorisation Application (MAA) for this therapy.
Notably, the renowned institution Clarivate recently featured relacorilant in a report, listing it as one of 11 innovative therapies to watch in 2026. Analysis revealed that, compared to nab-paclitaxel alone, patients receiving the relacorilant combination experienced a 35% reduction in the risk of death (HR=0.65, p=0.0004). The median OS for patients treated with relacorilant was 16.0 months, versus 11.9 months for those on nab-paclitaxel monotherapy, a difference of 4.1 months.
The relacorilant combination therapy demonstrated a favorable tolerability profile, consistent with its known safety characteristics. Importantly, the type, frequency, and severity of adverse events in the combination therapy group were comparable to those in the nab-paclitaxel monotherapy group. The efficacy benefit of relacorilant was achieved without adding to the patients' safety burden.
Corcept had previously announced that the ROSELLA trial also met its other primary endpoint of improved Progression-Free Survival (PFS), a result confirmed by Blinded Independent Central Review (BICR). Patients receiving the relacorilant combination therapy showed a 30% reduction in the risk of disease progression compared to those on nab-paclitaxel alone (HR=0.70, p=0.008).
Relacorilant is an oral, selective glucocorticoid receptor (GR) antagonist. It modulates cortisol activity by binding specifically to the GR without interacting with the body's other hormone receptors. Corcept is advancing the development of relacorilant for ovarian cancer and several other serious conditions, including endogenous hypercortisolism, 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 the treatment of hypercortisolism. It has also received Orphan Drug Designation from the EC for the treatment of ovarian cancer.
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