New Phase II Findings for ODM-208/MK-5684 Revealed at 2024 ASCO-GU Conference

During the 2024 ASCO Genitourinary Cancers Symposium, Orion showcased a new poster, offering further insights derived from the Phase II CYPIDES study. This research is meticulously assessing the tolerability and clinical outcomes of ODM-208 (also designated as MK-5684), a trial-phase oral CYP11A1 inhibitor. The focus is on patients who have undergone extensive prior treatments and are now confronting advanced metastatic castration-resistant prostate cancer, encompassing cases both with and without mutations in the androgen receptor ligand-binding domain (AR-LBD).

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Past literature predominantly examined androgen receptor (AR) gene mutations within the ligand-binding-domain (LBD). The latest findings provide preliminary insights from a supplementary group comprised mostly of AR-LBD wild-type cases, which enhances the earlier phase 2 findings.

Even when prostate cancer progresses to a stage that is unresponsive to castration, steroid hormones remain influential in its control. The early outcomes from the Phase II CYPIDES study indicate the robust efficacy of ODM-208/MK-5684 in halting the production of all steroid hormones, exhibiting notable therapeutic effects in extensively treated metastatic castration-resistant prostate cancer (mCRPC) subjects, notably those with AR-LBD mutations.

"It's quite compelling that those patients who are AR-LBD wild-type seem to gain advantages from using ODM-208/MK-5684 as well, although the decline in PSA levels was more commonly observed in individuals with the AR-LBD mutation. We are eager to uncover more comprehensive results from both AR-LBD positive and negative cohorts in the forthcoming Phase 3 trials," stated Professor Outi Vaarala, M.D., Ph.D., who functions as the Senior Vice President of Innovative Medicines and Research and Development at Orion.

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According to the data provided by the Synapse Database, As of January 31, 2024, there are 3 investigational drugs for the CYP11A1 target, including 6 indications, 7 R&D institutions involved, with related clinical trials reaching 10, and as many as 911 patents.

ODM-208/MK-5684 is an investigational oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as prostate cancer. The therapeutic areas of neoplasms and urogenital diseases highlight the potential applications of ODM-208 beyond prostate cancer.