Oric to advance prostate cancer drug to Phase III trials

Oric Pharmaceuticals said it will advance rinzimetostat in combination with darolutamide to a Phase III trial after a Phase Ib study showed a reported survival benefit. The Himalayas-1 study is planned to begin in 2026 and is slated to enroll about 600 patients with metastatic castration-resistant prostate cancer previously treated with abiraterone.

Oric Pharmaceuticals will move its drug candidate rinzimetostat into a Phase III trial after reporting a survival benefit in a Phase Ib study. The planned Himalayas-1 trial will evaluate oral rinzimetostat together with Bayer's Nubeqa (darolutamide) in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate. Oric said the trial is expected to initiate in 2026 and is slated to enroll about 600 patients. The company reported preliminary efficacy and safety data from the Phase Ib study that informed the decision to advance the 400 mg dose. Key facts: - The Phase Ib study included cohorts receiving 400 mg once daily (18 patients) and 600 mg once daily (15 patients) of rinzimetostat, each given with the standard dose of Nubeqa. - For the 400 mg cohort, reported radiographic progression-free survival (rPFS) rates were 93%, 84%, and 84% at three, four, and five months, respectively, with a median follow-up of 4.9 months. - The article reports a PSA50 response in 47% of patients (confirmed in 33%) and that 71% of patients had at least 50% ctDNA reductions across a range of AR mutations. - Oric said more treatment-emergent adverse events (TEAEs) in the 400 mg cohort were Grade 1 and consistent with PRC2 and AR inhibition; the 600 mg dose was associated with a modestly higher rate of adverse events and dose modifications. - The article mentions Oric's stock fell 18.9% from $12.64 at market open on March 31 to $10.25 at market open on April 1, and that Jefferies analysts suggested investors may view Johnson & Johnson's Erleada as a strategic alternative to Nubeqa. - Oric reported the U.S. annual incidence of mCRPC patients previously treated with abiraterone is approximately 17,000; a GlobalData report cited radioligand therapies and kinase inhibition as primary market growth drivers. Summary: Oric will advance the 400 mg rinzimetostat combination into a registrational Phase III study, Himalayas-1, which the company expects to start in 2026 and to enroll about 600 previously abiraterone-treated mCRPC patients. The company based the decision on preliminary efficacy and safety results from the Phase Ib study. Further clinical and regulatory outcomes are undetermined at this time.