ORIC Pharmaceuticals Reports 55% PSA50, 59% ctDNA Clearance in Prostate Cancer Trial

ORICORIC

ORIC Pharmaceuticals reported Phase 1b data showing 55% of metastatic castration-resistant prostate cancer patients achieved PSA50 and 20% achieved PSA90 with rinzimetostat plus AR inhibitors, while 59% attained ctDNA clearance. ORIC Pharmaceuticals expects dose optimization data in 1Q 2026 and to initiate Phase 3 mCRPC trial in 1H 2026.

1. Strong Phase 1b Data for Rinzimetostat in Prostate Cancer

ORIC Pharmaceuticals announced that its allosteric PRC2 inhibitor rinzimetostat achieved notable efficacy and safety in a Phase 1b trial of metastatic castration-resistant prostate cancer. When administered in combination with approved androgen receptor inhibitors, 55% of patients experienced at least a 50% decline in prostate-specific antigen (PSA50), while 20% achieved a 90% reduction (PSA90). In addition, 59% of evaluable patients showed clearance of circulating tumor DNA (ctDNA), suggesting deep molecular responses. The safety profile was differentiated, with low rates of Grade 3 or higher adverse events and no new safety signals, supporting continued development toward registrational studies.

2. Enozertinib Shows High Response Rates in EGFR Exon 20 Mutations

At the same conference, ORIC reported Phase 1b data for enozertinib in first-line non–small cell lung cancer patients harboring EGFR exon 20 insertions. The overall response rate (ORR) was 67%, including tumor shrinkage in two-thirds of participants, while intracranial ORR reached 100% in patients with measurable central nervous system disease. These results underscore enozertinib’s potential to address a high-unmet-need subgroup with limited targeted therapy options and strengthen ORIC’s position in the lung cancer market segment.

3. Extended Cash Runway and Upcoming Milestones

ORIC bolstered its leadership team in 2025 and significantly extended its cash runway into the second half of 2028, positioning the company to advance its lead assets without near-term financing risk. Next milestones include reporting combination dose-optimization data for rinzimetostat in the first quarter of 2026 and initiating the company’s first global Phase 3 registrational trial in metastatic castration-resistant prostate cancer in the first half of 2026. These catalysts, combined with differentiated clinical profiles, are expected to drive value inflection points and support potential partnerships or licensing discussions.

Sources

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