On July 14, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the initiation of the Himalayas-1 global Phase 3 registrational trial in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone and announced a clinical trial collaboration and supply agreement with Bayer AG ("Bayer").
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Himalayas-1 Global Phase 3 Registrational Trial Initiation
ORIC previously presented dose optimization data for rinzimetostat in combination with darolutamide and selected 400 mg once daily rinzimetostat as the recommended Phase 3 dose (RP3D). Following End-of-Phase 1 interactions with the FDA and other global health authorities, ORIC finalized the trial protocol and has initiated the Himalayas-1 global Phase 3 registrational trial.
The Himalayas-1 trial is expected to enroll approximately 600 patients from over 250 sites in 25 countries, randomized 1:1 to receive the RP3D of 400 mg once daily rinzimetostat (with or without food) in combination with darolutamide versus physician’s choice of an androgen receptor (AR) inhibitor or docetaxel. The primary endpoint is radiographic progression-free survival, the key secondary endpoint is overall survival, and additional secondary endpoints include PSA response rate, objective response rate and patient reported outcomes.
Clinical Trial Collaboration and Supply Agreement with Bayer
Under the terms of the agreement, ORIC will conduct and sponsor the Himalayas-1 trial and Bayer will provide their AR inhibitor, NUBEQA (darolutamide), at no cost for use in the trial in combination with rinzimetostat. This agreement does not grant Bayer any license, option, or other rights to rinzimetostat and ORIC retains full global development and commercial rights to rinzimetostat.
"Given the significant unmet need in prostate cancer and the potential best-in-disease clinical profile that rinzimetostat has continued to demonstrate, the initiation of our Himalayas-1 Phase 3 trial represents an important milestone toward establishing rinzimetostat as a potentially practice-changing therapy for patients," said Jacob M. Chacko, M.D., president and chief executive officer. "This collaboration with Bayer strengthens our global operational readiness by securing access to darolutamide for Himalayas-1 and underscores our shared interest in evaluating this regimen for patients with prostate cancer."
(Press release, ORIC Pharmaceuticals, JUL 14, 2026, View Source [SID1234669209])