ORIC Pharmaceuticals Launches Global Phase 3 Trial Of Rinzimetostat For Advanced Prostate Cancer

ORIC Pharmaceuticals, Inc., a clinical-stage oncology company focused on developing therapies that overcome treatment resistance in cancer, has announced the initiation of the global Phase 3 Himalayas-1 registrational trial for patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received treatment with abiraterone. The company also announced a clinical trial collaboration and drug supply agreement with Bayer AG to support the study.

The Phase 3 Himalayas-1 trial marks an important step in the clinical development of ORIC's investigational therapy, rinzimetostat. Earlier clinical studies evaluated different dose levels of rinzimetostat in combination with darolutamide, leading the company to select a once-daily 400 mg dose as the recommended Phase 3 dose (RP3D). After completing End-of-Phase 1 discussions with the U.S. Food and Drug Administration (FDA) and other international regulatory agencies, ORIC finalized the study protocol and officially launched the global Phase 3 trial.

The Himalayas-1 study is expected to enroll approximately 600 patients across more than 250 clinical sites in 25 countries. Participants will be randomly assigned in a 1:1 ratio to receive either the recommended Phase 3 dose of 400 mg rinzimetostat once daily, with or without food, in combination with darolutamide, or the current standard treatment selected by the treating physician, which may include another androgen receptor (AR) inhibitor or docetaxel chemotherapy.

The primary objective of the study is to evaluate radiographic progression-free survival, which measures how long patients live without their disease worsening based on imaging scans. Overall survival has been selected as the key secondary endpoint. Additional secondary endpoints include prostate-specific antigen (PSA) response rate, objective response rate, and patient-reported outcomes that assess symptoms and quality of life during treatment.

In addition to launching the Phase 3 study, ORIC has entered into a clinical trial collaboration and supply agreement with Bayer AG. Under the terms of the agreement, ORIC will sponsor and manage the Himalayas-1 trial, while Bayer will provide its androgen receptor inhibitor, NUBEQA® (darolutamide), at no cost for use in combination with rinzimetostat throughout the study.

The companies emphasized that the agreement is limited to supporting the clinical trial. Bayer will not receive any licensing rights, development options, or commercial rights related to rinzimetostat. ORIC will retain full worldwide ownership and exclusive global development and commercialization rights for the investigational therapy.

Jacob M. Chacko, M.D., President and Chief Executive Officer of ORIC Pharmaceuticals, said the initiation of the Phase 3 Himalayas-1 trial represents a major milestone for the company. He noted that patients with metastatic castration-resistant prostate cancer continue to face significant unmet medical needs despite currently available therapies. Based on the encouraging clinical profile demonstrated by rinzimetostat so far, he believes the investigational treatment has the potential to become a practice-changing option for patients if future studies confirm its benefits.

Dr. Chacko also said that the collaboration with Bayer strengthens ORIC's ability to efficiently conduct the global Phase 3 study by ensuring access to darolutamide for use in the combination regimen. He added that the agreement reflects both companies' shared interest in evaluating this treatment approach as a potential new option for patients with advanced prostate cancer.