Corcept Therapeutics reported positive data from the pivotal Phase III ROSELLA trial assessing relacorilant in combination with nab-paclitaxel in platinum-resistant ovarian cancer (PROC). The combination achieved the overall survival (OS) primary endpoint versus chemotherapy alone, with the trial results not limited by biomarker.

ROSELLA enrolled 381 patients with recurrent disease resistant to platinum-based regimens. In the study, patients receiving relacorilant plus nab-paclitaxel experienced a 35% reduction in the risk of death compared with those treated with nab-paclitaxel alone (hazard ratio: 0.65; median OS 16.0 months vs 11.9 months, a 4.1-month improvement, p = 0.0004). The combination was well-tolerated, with safety outcomes similar to nab-paclitaxel monotherapy, and did not increase the overall adverse event burden.

ROSELLA has dual primary endpoints of OS and progression-free survival (PFS). Corcept announced in March 2025 that the PFS endpoint had been met with a 30% reduction in disease progression risk with the relacorilant combination. Of note, the ROSELLA findings indicate relacorilant was effective regardless of patient biomarker status.

What next for relacorilant

Relacorilant is a selective glucocorticoid receptor modulator (SGRM) designed to antagonize the glucocorticoid receptor (GR), thereby mitigating the pathological effects of excess cortisol in Cushing’s syndrome and overcoming glucocorticoid-mediated chemoresistance in certain cancers, notably PROC. The firm has produced pivotal Phase III data supporting its use in both endocrine and oncology indications, however the FDA recently issued a CRL in relation to Corcept’s Cushing’s syndrome NDA, requesting more data to support risk-benefit analysis.

Corcept said full ROSELLA results will be presented at an upcoming medical meeting, and the data are being used to support regulatory filings in both the US and EU. In the United States, relacorilant’s New Drug Application (NDA) for PROC is under FDA review with a Prescription Drug User Fee Act (PDUFA) target action date of July 11, 2026, while a Marketing Authorization Application (MAA) is also under review by the European Medicines Agency (EMA).