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MEDTECH ODM-208: A New Frontier in Hormone-Targeted Therapies for Advanced Prostate Cancer
A recent study explored the efficacy of ODM-208, a novel inhibitor targeting cytochrome P450 11A1, in treating metastatic castration-resistant prostate cancer (mCRPC). This study is pivotal in understanding the potential of new therapeutic strategies for a condition that continues to challenge oncologists worldwide.
Study Design
- Type of Study: First-in-human phase 1 and phase 2 clinical trial (CYPIDES study).
- Participants: 92 patients with heavily pretreated mCRPC.
- Treatment: ODM-208 administered twice daily, combined with glucocorticoid/mineralocorticoid replacement and ongoing androgen deprivation therapy.
- Phases: Phase 1 included patients regardless of androgen receptor gene mutations, while phase 2 focused on patients with activating mutations.
Key Findings
- Optimal Dosage: 5 mg of ODM-208 twice daily, with dexamethasone 1 mg and fludrocortisone 0.1 mg.
- Main Toxicity: Treatment-related adrenal insufficiency.
- Testosterone Levels: Declined to undetectable levels in 87% of patients at the 5 mg dosage.
- Prostate-Specific Antigen Levels: 50% or more reduction observed in 73.7% of patients with AR mutations in phase 1 and 53.3% in phase 2.
Cytochrome P450 11A1 (CYP11A1), targeted by ODM-208, is essential in adrenal mitochondria for initiating the biosynthesis of steroid hormones, including the first step in converting cholesterol into pregnenolone. This process is vital in the production of all steroid hormones.
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