SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, July 14, 2026
ORIC Pharmaceuticals announced the initiation of the global Himalayas-1 Phase 3 registrational trial evaluating rinzimetostat in combination with NUBEQA® (darolutamide) for patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone. The company also entered into a clinical trial collaboration and supply agreement with Bayer, under which Bayer will provide darolutamide for the study while ORIC retains full global development and commercialization rights to rinzimetostat.
Global Phase 3 Trial Targets Patients with Advanced mCRPC
The Himalayas-1 trial is expected to enroll approximately 600 patients across more than 250 clinical sites in 25 countries. Participants will be randomized to receive the recommended Phase 3 dose of 400 mg once-daily rinzimetostat in combination with darolutamide or physician’s choice of another androgen receptor inhibitor or docetaxel. The study’s primary endpoint is radiographic progression-free survival (rPFS), while key secondary endpoints include overall survival, PSA response rate, objective response rate, and patient-reported outcomes. The Phase 3 design follows positive dose optimization data and End-of-Phase 1 discussions with the U.S. Food and Drug Administration and other global regulatory authorities.
Bayer Collaboration Supports Global Clinical Development
As part of the clinical collaboration and supply agreement, Bayer will supply NUBEQA® (darolutamide) at no cost for use in the Himalayas-1 study. The agreement is limited to clinical trial support and does not provide Bayer with any licensing or commercialization rights to rinzimetostat. ORIC emphasized that it maintains complete ownership of the investigational therapy while benefiting from reliable access to darolutamide for the global Phase 3 program.
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Rinzimetostat Advances as Potential Practice-Changing Therapy
Rinzimetostat is an investigational allosteric inhibitor of the Polycomb Repressive Complex 2 (PRC2) targeting the EED subunit, developed to overcome therapeutic resistance in prostate cancer. ORIC believes the initiation of the registrational Himalayas-1 trial marks a significant milestone toward establishing rinzimetostat as a potential new treatment option for patients with advanced mCRPC. The collaboration with Bayer is expected to strengthen operational execution while accelerating development of the combination regimen for patients with limited treatment options.
Source: ORIC Pharmaceuticals, press release
