Orris Pharmaceuticals: entered clinical trial collaboration and supply agreement with Bayer to provide Darolutamide for Himalayas-1

ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC) has entered into a clinical trial collaboration and supply agreement with Bayer to provide darolutamide for use in its upcoming Himalayas-1 Phase 3 global registrational trial of rinzimetostat (ORIC-944) in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone. The agreement supports the planned initiation of the trial in the first half of 2026, with rinzimetostat administered at the RP3D of 400 mg once daily in combination with darolutamide.

The Himalayas-1 trial will enroll approximately 600 patients across over 250 sites in more than 20 countries. Participants will be randomized 1:1 to receive the combination therapy or a physician’s choice of an androgen receptor inhibitor or chemotherapy. The primary endpoint of the trial is radiographic progression-free survival (rPFS), with overall survival as the key secondary endpoint.

The decision to select the 400 mg once-daily dose of rinzimetostat was based on a comprehensive exposure-response analysis and safety data from the Phase 1b trial. The combination demonstrated a favorable safety profile, with most treatment-related adverse events being mild (Grade 1 or 2) and minimal dose modifications required. Early efficacy data also showed promising results, including landmark rPFS rates and significant reductions in circulating tumor DNA (ctDNA).

The collaboration with Bayer underscores ORIC’s strategic approach to advancing its pipeline and aligns with its focus on overcoming resistance in cancer. The agreement also reflects the company’s commitment to leveraging partnerships to accelerate clinical development and regulatory pathways.