Corcept’s Relacorilant Meets Primary Endpoint in Ovarian Cancer Trial — Corcept Therapeutics Incorporated

Event summary

Corcept’s Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer met its primary endpoint of overall survival (OS).
Patients treated with relacorilant had a 35% reduction in the risk of death (hazard ratio: 0.65; p-value: 0.0004) and a median OS of 16.0 months vs. 11.9 months for nab-paclitaxel alone.
The trial enrolled 381 patients across the U.S., Europe, South Korea, Brazil, Argentina, Canada, and Australia.
Relacorilant has been designated an orphan drug by the FDA and the European Commission (EC) for hypercortisolism and ovarian cancer.
The FDA has assigned a PDUFA date of July 11, 2026, for relacorilant in platinum-resistant ovarian cancer.

The big picture

Corcept’s success in the ROSELLA trial positions relacorilant as a potential new standard-of-care treatment for platinum-resistant ovarian cancer, a disease with limited therapeutic options. The trial’s results highlight the role of cortisol modulation in enhancing chemotherapy efficacy, a mechanism that could have broader implications for other solid tumors. The strategic anomaly here is the absence of biomarker requirements, suggesting a potentially wider patient population eligible for treatment.

What we're watching

Regulatory Approval: Whether the FDA and EMA will approve relacorilant for platinum-resistant ovarian cancer by the PDUFA date of July 11, 2026.
Market Expansion: The pace at which Corcept can expand relacorilant’s use to earlier stages of ovarian cancer and other tumors expressing the glucocorticoid receptor.
Competitive Dynamics: How relacorilant’s combination with nab-paclitaxel will position against existing and emerging treatments for platinum-resistant ovarian cancer.