ORIC Pharmaceuticals will advance its prostate cancer drug to Phase III trials after it showed survival benefit in a Phase Ib study.
The Himalayas-1 trial will evaluate rinzimetostat, an oral imidazopyrimidine binder that inhibits polycomb protein EED, plus 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 set to initiate in 2026 and is slated to enrol 600 patients.
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Despite news of its advancement, Oric’s stock dropped 18.9% from $12.64 at market open on 31 March to $10.25 at market open on 1 April. Jefferies analysts believe the negative stock move could be due to investors considering Johnson & Johnson’s Erleada as a “better fit strategically” than Nubeqa.
In the Phase Ib study, 18 patients were treated with 400mg of rinzimetostat once daily and 15 patients were treated with 600mg of rinzimetostat once daily, both in combination with the standard dose of Nubeqa.
Preliminary efficacy data showed radiographic progression-free survival (rPFS) rates of 93%, 84%, and 84% at three, four, and five months, respectively, with a median follow-up of 4.9 months. This was following treatment with the 400mg study drug combination.
Oric said this data is superior to available standard-of-care therapies, including Xtandi, Jevtana, and Pluvicto, where the five-month landmark rPFS for these approved therapies ranges from approximately 60% to 75%.
PSA50 response, another endpoint, was achieved in 47% of patients and confirmed in 33% of patients. A total of 71% of patients achieved at least 50% ctDNA reductions across a range of AR mutations.
Based on the efficacy and safety data, Oric will advance the 400mg therapy to Phase III trials, with more treatment-emergent adverse events (TEAEs) in this cohort being Grade 1 in severity and consistent with PRC2 and AR inhibition. Meanwhile, the 600mg dose was associated with a modestly higher rate of AEs and dose modifications.
Dr Pratik Multani, chief medical officer of Oric, said: “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.”
In the US, the annual incidence of mCRPC patients previously treated with abiraterone is approximately 17,000.
A GlobalData report identifies radioligand therapies and kinase inhibition to be the primary drivers of market growth, although specific targeted therapies exploiting HER2/3+, EZH2, and targeted immune markers are also expected to contribute to long-term market growth.
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