ORIC Pharmaceuticals starts Phase 3 Himalayas-1 trial, adds Bayer supply deal

ORIC Pharmaceuticals said it finalized the trial protocol and started the Himalayas-1 global Phase 3 registrational study after End-of-Phase 1 discussions with the FDA and other global health authorities.¹

The trial targets patients with metastatic castration-resistant prostate cancer previously treated with abiraterone. It is designed to enroll about 600 patients across more than 250 sites in 25 countries, with patients randomized evenly to receive rinzimetostat at 400 mg once daily, taken with or without food, alongside darolutamide, compared against a physician-selected androgen receptor inhibitor or docetaxel.¹ The primary endpoint is radiographic progression-free survival, with overall survival as the key secondary endpoint.¹

ORIC also entered a supply and collaboration agreement with Bayer for the trial. Under the deal, ORIC will run and sponsor Himalayas-1 while Bayer supplies its AR inhibitor NUBEQA (darolutamide) at no cost for use with rinzimetostat.¹ ORIC said the arrangement leaves rinzimetostat's rights fully with ORIC, since Bayer receives no license, option, or other rights to rinzimetostat, and ORIC keeps full global development and commercial control over the drug.¹

On enozertinib, the company's EGFR-targeted candidate for non-small cell lung cancer, ORIC pointed to upcoming data: 1L EGFR atypical monotherapy results are set for presentation at the ESMO Congress in October 2026, with 1L EGFR exon 20 insertion monotherapy and combination data with subcutaneous amivantamab expected in the second half of 2026.¹ A rinzimetostat program update is also expected in the second half of 2026.

Financially, the company reported cash, cash equivalents and investments of $387.6 million as of June 30, 2026, which it said should fund operations into the second half of 2028.¹