Oric Pharmaceuticals announces preliminary efficacy, safety data from ORIC-944

Oric Pharmaceuticals (ORIC) announced preliminary efficacy and safety data from the ongoing Phase 1b trial of once daily ORIC-944 in combination with androgen receptor inhibitors in patients with metastatic castration-resistant prostate cancer. Data include 17 patients with mCRPC previously treated with a median of three lines of prior therapy, including abiraterone, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. This median does not include androgen deprivation therapy or first-generation androgen receptor deprivation therapy. Patients were treated once daily with 400 mg, 600 mg, or 800 mg of ORIC-944 in combination with 240 mg of apalutamide once daily or with 600 mg of darolutamide twice daily. PSA response data are as of May 9. Overall, 59% of patients achieved a PSA50 response and nearly all patients with a PSA50 response were confirmed one month later, for a confirmed PSA50 response rate of 47%, which does not include one additional PSA response pending confirmation. 24% of patients achieved a PSA90 response, all of which were subsequently confirmed. PSA responses were observed across all ORIC-944 dose levels and were also observed at comparable rates in combination with apalutamide or with darolutamide. The majority of patients are still ongoing with multiple patients approaching one year or more on therapy. Further dose exploration is ongoing. Following completion of the Phase 1b dose exploration portion of the trial expected in mid-2025, the company plans to evaluate two candidate RP2Ds for each combination in the dose optimization portion of the trial in 2H 2025. Data from the dose optimization portion of the trial will inform the choice of ORIC-944 dose to advance in combination with apalutamide or with darolutamide in the first global Phase 3 registrational trial in mCRPC that the company expects to initiate in 1H 2026.