Orion Corporation and MSD (known as Merck & Co., Inc. in the United States and Canada) have initiated two pivotal Phase III clinical trials evaluating ODM-208/MK5684, an investigational CYP11A1 inhibitor, in combination with hormone replacement therapy (HRT), for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).
Patients are now enrolling in the trials, named OMAHA1 (NCT06136624) and OMAHA2a (NCT06136650).
“The start of our codevelopment Phase III programme with MSD provides exciting opportunities to evaluate the potential of ODM-208/MK5684 as a novel treatment of mCRPC, both in front-line and late-line patients, including those with and without androgen receptor ligand binding domain (AR LBD) mutations,” said Professor Outi Vaarala, Senior Vice President, Innovative Medicines and Research and Development, Orion.
“Our ultimate aim is to bring innovative medicines to all patients with unmet need and we look forward to the beginning of these studies with our partner, MSD.”
“By inhibiting CYP11A1 enzyme activity, we believe ODM-208/MK5684 represents a compelling approach to suppress the production of steroid hormones, a key driver of prostate cancer,” said Dr Scot Ebbinghaus, Vice President, Global Clinical Development, MSD Research Laboratories.
“The initiation of these two Phase 3 trials of ODM-208/MK5684 in different stages of mCRPC, in collaboration with Orion, demonstrates our continued commitment to exploring innovative new approaches and pathways to treat this complex disease.”
OMAHA1 is a randomised, open-label Phase III trial evaluating ODM-208/MK5684 in combination with HRT for the treatment of patients with later-line mCRPC who have failed one prior new hormonal agent (NHA) and one or two prior taxane-based chemotherapies compared to an alternative NHA (abiraterone or enzalutamide).
The trial will enroll an estimated 1200 patients around the world. The primary endpoints are overall survival (OS) and radiographic progression-free survival (rPFS) by AR LBD mutation status. Secondary endpoints include time to first subsequent therapy (TFST), objective response rate (ORR) and duration of response (DOR).
OMAHA2a is a randomised, open-label Phase III trial evaluating ODM-208/MK5684 in combination with HRT for the treatment of patients with front-line mCRPC who have failed one prior NHA compared to physician’s choice of NHA (abiraterone or enzalutamide).
The trial will enroll an estimated 1500 patients around the world. The primary endpoints are OS and rPFS by AR LBD mutation status. Secondary endpoints include TFST, ORR and DOR.