ORIC® Pharmaceuticals Reports Selection of Rinzimetostat RP3D in Combination with Darolutamide for Himalayas-1 Phase 3 Global Study with Dose Optimization Data Supporting Its Potential Best-in-Disease Profile

Core Insights - Rinzimetostat 400 mg once daily has been selected as the recommended Phase 3 dose (RP3D) in combination with darolutamide for the Himalayas-1 global Phase 3 registrational trial in post-abiraterone metastatic castration-resistant prostate cancer (mCRPC), with initiation expected in the first half of 2026 [1][4][10] - The 5-month radiographic progression-free survival (rPFS) rate of 84% is consistent with competitor PRC2 inhibitors and significantly better than standard care therapies in mCRPC [1][16] - Rinzimetostat demonstrates a highly differentiated safety profile with a lower frequency and severity of adverse events compared to competitor regimens, with most adverse events being Grade 1 or 2 [1][6][10] Company Updates - ORIC Pharmaceuticals, Inc. is focused on developing treatments that address mechanisms of therapeutic resistance in oncology [3][17] - The company plans to host a conference call and webcast to discuss the rinzimetostat program update [2][15] - The Himalayas-1 trial will enroll approximately 600 patients from over 250 sites in more than 20 countries, randomized to receive either the RP3D of rinzimetostat or physician's choice of an AR inhibitor or chemotherapy [10] Clinical Trial Details - The Phase 1b trial of rinzimetostat in combination with darolutamide involved patients who had previously received a median of two lines of therapy, including abiraterone [5][14] - The recommended Phase 3 dose was selected based on a comprehensive exposure-response analysis, which indicated that the 400 mg dose provided comparable efficacy with a better safety profile than the 600 mg dose [7][8] - Early efficacy data show promising results, with landmark rPFS rates of 93%, 84%, and 84% at 3, 4, and 5 months, respectively, and significant PSA response rates [10][13][16] Market Potential - The annual incidence of mCRPC patients previously treated with abiraterone in the US is approximately 17,000, with an estimated addressable market exceeding $3.5 billion and a total global addressable market of $7 billion [11]