Corcept planning US, EU submissions for cortisol modulator after ovarian cancer win
Corcept Therapeutics' Phase 3 ROSELLA Trial Success
Key Findings
- Relacorilant plus nab-paclitaxel showed a 30% reduction in disease progression risk compared to nab-paclitaxel alone in platinum-resistant ovarian cancer patients24.
- Median progression-free survival improved to 6.5 months vs 5.5 months for the control group4.
- Interim overall survival data demonstrated a 4.5-month advantage (16.0 vs 11.5 months)4.
- No new safety concerns were identified4.
Regulatory Plans
- Corcept plans to submit a New Drug Application (NDA) to the FDA in Q3 202524.
- A Marketing Authorization Application (MAA) in Europe will follow shortly after4.
Trial Details
- The ROSELLA trial enrolled 381 patients across multiple countries4.
- Collaboration with prestigious oncology research networks adds credibility to the findings4.
Potential Impact
- Results could establish relacorilant plus nab-paclitaxel as a new standard of care for platinum-resistant ovarian cancer4.
- Represents a significant expansion of Corcept's commercial portfolio beyond current cortisol modulation products4.
About Relacorilant
- Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor13.
- It is being studied for various disorders including hypercortisolism, ovarian, adrenal, and prostate cancer3.
Corcept's stock surged 85% following the announcement, reflecting the market's positive reception of these results2.
Sources:
1. https://www.stocktitan.net/news/CORT/fda-files-corcept-s-new-drug-application-for-relacorilant-as-6nrj28be8ry5.html
2. https://www.fiercebiotech.com/biotech/corcepts-investigational-oral-therapy-cuts-ovarian-cancer-progression-30-teeing-fda-filing
3. https://www.drugs.com/nda/relacorilant_250303.html
4. https://www.stocktitan.net/news/CORT/primary-endpoint-met-in-corcept-s-pivotal-phase-3-rosella-trial-of-jbxqochi03ck.html