Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating ODM-208/MK5684 in Certain Patients with Metastatic Castration-Resistant Prostate Cancer

ORION CORPORATION
PRESS RELEASE
05 JANUARY 2023 at 13:45 EET              
        
Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating ODM-208/MK5684 in Certain Patients with Metastatic Castration-Resistant Prostate Cancer

• OMAHA1 and OMAHA2a are the first Phase 3 trials to be initiated for ODM-208/MK5684

Orion Corporation (“Orion”) and MSD (known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada) have initiated two pivotal Phase 3 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 co-development Phase 3 program 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 randomized, open-label Phase 3 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 1,200 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 randomized, open-label Phase 3 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 1,500 patients around the world. The primary endpoints are OS and rPFS by AR LBD mutation status. Secondary endpoints include TFST, ORR and DOR.

About ODM-208/MK-5684

ODM-208/MK5684 is an oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion and is being investigated for the treatment of hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 enzyme activity, ODM-208/MK5684 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

About metastatic castration-resistant prostate cancer

Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. In patients with mCRPC, their prostate cancer grows and spreads to other parts of the body, despite the use of androgen-deprivation therapy to block the action of male sex hormones. Approximately 10-20% of patients with prostate cancer are estimated to develop castration-resistant prostate cancer (CRPC) within five years, with at least 84% of these patients presenting with metastases at the time of CRPC diagnosis. Of patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years. mCRPC is associated with a significant mortality rate.

Contact person:
Terhi Ormio, VP Communications
Orion Corporation
tel. +358 50 966 4646
e-mail: terhi.ormio@orion.fi

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
www.orion.fi

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and self-care products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion’s net sales in 2022 amounted to EUR 1,341 million and the company had about 3,500 employees at the end of the year. Orion’s A and B shares are listed on Nasdaq Helsinki.