0001193125-26-134618
SEC filingORIC Pharmaceuticals presented a rinzimetostat (ORIC-944) program update on March 31, 2026, announcing the selection of a provisional Phase 3 dose and plans to initiate a first Phase 3 trial in post-abiraterone mCRPC in 1H 2026.
ORIC Pharmaceuticals announced a significant milestone in its rinzimetostat (ORIC-944) development program, selecting a provisional recommended Phase 3 dose (RP3D) of 400 mg QD in combination with darolutamide. The decision is supported by dose optimization data from the Phase 1b trial, which demonstrated a highly competitive efficacy profile. The combination achieved an 84% 5-month radiographic progression-free survival (rPFS) rate and a 33% PSA50 response rate in post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) patients. Crucially, the safety profile appears differentiated from competitor PRC2 inhibitors, with the majority of adverse events being Grade 1 and no Grade 4/5 events reported, which management suggests is conducive to long-term dosing. The company plans to initiate its first Phase 3 trial in this indication in the first half of 2026. The target patient population, post-abiraterone mCRPC, represents a significant commercial opportunity with an estimated $3.5 billion annual total addressable market in the US, characterized by a lack of oral and well-tolerated therapies.