ODM-209 / Orion Corp - LARVOL DELTA

ODM-209, a CYP 11A1 inhibitor in patients with mCRPC: Results from the STESIDES phase 1 study. (ASCO 2024) - P1/2 | "Of 34 patients with mCRPC, 18 (53%) had previously received both abiraterone and enzalutamide, and 18 (53%) patients both docetaxel and cabazitaxel; 19 patients (56%) had activating AR-LBD mutations detected at baseline. Phase 1 results of ODM-209 suggest activity in heavily pre-treated patients with mCRPC particularly in those with activating AR-LBD mutations, with expected on-target AE's. Similar findings were recently reported with ODM-208/MK-5684 (NEJM Evidence 2023)."

Clinical • P1 data • Breast Cancer • Cardiovascular • Endocrine Disorders • Fatigue • Heart Failure • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Nephrology • Prostate Cancer • Renal Disease • ER • HER-2

STESIDES: Safety and Pharmacokinetics of ODM-209 (clinicaltrials.gov) - P1/2 | N=38 | Completed | Sponsor: Orion Corporation, Orion Pharma | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • ER • HER-2

Androgen receptor (AR) mutations in men with metastatic castration-resistant prostate cancer (mCRPC): Incidence and natural history. (ASCO-GU 2023) - P1, P1/2 | "Two early phase trials investigating CYP11A1 inhibitors - CYPIDES (ODM208, NCT03436485) and STESIDES (ODM209, NCT03878823) - recruited mCRPC patients with and without pre-specified AR LBD mutation...Overall, 212 (78%), 202 (74%), and 240 (88%) patients had received previous abiraterone, enzalutamide, and docetaxel respectively... AR LBD mutations were detected in ctDNA in 25% of men with advanced mCRPC treated with at least one ARSI. Their incidence was associated with a longer duration of treatment with enzalutamide and a longer time from CRPC and prostate cancer diagnosis. >"

Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • STING

STESIDES: Safety and Pharmacokinetics of ODM-209 (clinicaltrials.gov) - P1/2 | N=38 | Active, not recruiting | Sponsor: Orion Corporation, Orion Pharma | Trial completion date: Jan 2023 ➔ Oct 2023 | Trial primary completion date: Jan 2023 ➔ Oct 2023

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Prostate Cancer • Solid Tumor • ER • HER-2

STESIDES: Safety and Pharmacokinetics of ODM-209 (clinicaltrials.gov) - P1/2; N=38; Active, not recruiting; Sponsor: Orion Corporation, Orion Pharma; Recruiting ➔ Active, not recruiting; N=256 ➔ 38

Clinical • Enrollment change • Enrollment closed • Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Prostate Cancer • Solid Tumor • ER • HER-2