Oric(US:ORIC) Globenewswire·2025-12-05 06:00Core Insights - ORIC Pharmaceuticals announced data from a Phase 1b trial of enozertinib (ORIC-114) for treating NSCLC patients with HER2 exon 20 mutations, showing a 35% overall response rate (ORR) and 100% disease control rate (DCR) in the 80 mg cohort [1][8] - The trial included patients with active brain metastases, and the safety profile was manageable with a low discontinuation rate due to treatment-related adverse events (TRAEs) [1][4] - Enrollment for the HER2 exon 20 patient population has been completed, with no further development planned, while the 80 mg dose has been selected for potential Phase 3 development based on preliminary data [6][8] Trial Design and Patient Demographics - The Phase 1b trial evaluated enozertinib in patients with locally advanced or metastatic NSCLC with HER2 exon 20 mutations, allowing for patients with untreated brain metastases [2] - As of the cutoff date, 49 patients were dosed, with 80% having received prior chemotherapy and 35% having undergone HER2 targeted therapy [3] Safety and Efficacy Analysis - Enozertinib was well tolerated, with most TRAEs being Grade 1 or 2, and only 2 patients discontinued treatment due to TRAEs [4] - Tumor responses were noted in both dosing cohorts, with deeper regressions observed in the 80 mg cohort, potentially due to fewer dose reductions [5] Next Steps and Future Development - The company plans to continue enrollment and follow-up in 1L NSCLC patients with EGFR exon 20 and other mutations, with updates expected in mid-2026 [6] - The 80 mg QD oral enozertinib has been selected for potential Phase 3 development based on the trial results [6] Conference Call and Webcast - ORIC will host a conference call and webcast on December 6, 2025, to discuss the trial results and future plans [7]