ORIC Pharmaceuticals has selected a 400 mg once‑daily dose of rinzimetostat (ORIC‑944) as the recommended Phase 3 dose for its Himalayas‑1 global registrational trial in metastatic castration‑resistant prostate cancer (mCRPC) patients previously treated with abiraterone. The trial will enroll roughly 600 patients from more than 250 sites in over 20 countries, with a primary endpoint of radiographic progression‑free survival and secondary endpoints including overall survival, PSA response, and patient‑reported outcomes.
The dose choice follows Phase 1b data that demonstrated a balance between efficacy and safety at 400 mg once‑daily. Exposure‑response analyses showed that higher drug exposure was associated with increased toxicity and dose modifications, making 400 mg the optimal dose for the pivotal study.
Jacob M. Chacko, M.D., president and chief executive officer, said, "The combination dose optimization data announced today provide confirmatory evidence that support rinzimetostat's potential best‑in‑disease clinical profile, reinforcing its path towards becoming a practice‑changing therapy for patients with prostate cancer." Chief medical officer Pratik S. Multani added, "These data provide compelling validation for advancing rinzimetostat in combination with darolutamide into Phase 3 registrational trials in patients with prostate cancer. We expect our first Phase 3 trial, Himalayas‑1, in patients with mCRPC previously treated with abiraterone, to initiate in the first half of 2026 while we continue to evaluate rinzimetostat in additional indications in prostate cancer and beyond."
ORIC’s strategy focuses on two high‑potential oncology assets—rinzimetostat for prostate cancer and enozertinib for non‑small cell lung cancer—allowing the company to concentrate resources on the most promising candidates. The company’s cash position, $392 million as of December 31 2025 plus $20 million raised thereafter, provides a runway through the second half of 2028, supporting the upcoming Phase 3 studies.
Metastatic castration‑resistant prostate cancer after abiraterone treatment represents a significant unmet need, with an estimated 17,000 patients in the United States annually. Rinzimetostat, an allosteric inhibitor of the polycomb repressive complex 2 via the EED subunit, targets mechanisms of therapeutic resistance, positioning it as a potential best‑in‑disease therapy in a competitive landscape that includes chemotherapy, androgen‑receptor inhibitors, radiopharmaceuticals, immunotherapy, and PARP inhibitors.
The Himalayas‑1 trial will randomize patients to rinzimetostat plus darolutamide versus physician’s choice of an androgen‑receptor inhibitor or chemotherapy. The design and endpoints aim to demonstrate clinical benefit and support regulatory approval, marking a critical de‑risking step toward commercialization.
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