Business
ORIC® Pharmaceuticals Presents Enozertinib Data in NSCLC Patients with HER2 Exon 20 Mutations at the ESMO Asia Congress 2025
Systemic activity of 35% ORR in 2L+ patients, including in patients with active brain metastases Manageable safety profile with low discontinuation rate
About this update from Oric Pharmaceuticals, Inc.
[{"type":"text","content":"Systemic activity of 35% ORR in 2L+ patients, including in patients with active brain metastases Manageable safety profile with low discontinuation rate Enrollment completed; no further development planned in this patient population Company to host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Dec. 05, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, announced data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025. Data in previously treated NSCLC patients with HER2 exon 20 mutations were presented at a poster session, and the poster can be found in the publication section of ORIC’s website here. Enozertinib Phase 1b Trial DesignEnozertinib is being evaluated in a Phase 1b trial in patients with locally advanced or metastatic NSCLC with HER2 exon 20 mutations. Notably, enrollment allows patients with active untreated brain metastases. Prior therapies include chemotherapy and HER2 targeted therapies. The primary endpoint of the trial is to determine the recommended Phase 2 dose (RP2D), and secondary endpoints include investigator-assessed objective response rate (ORR), disease control rate (DCR), and safety. Previously Treated NSCLC Patients with HER2 Exon 20 MutationsAs of the August 29, 2025 cutoff date, 49 patients were dosed — 26 patients received 80 mg QD oral enozertinib and 23 patients received 120 mg QD. Patients were treated with up to 4 prior therapies, with 80% of patients having received prior chemotherapy and 35% having received a prior HER2 targeted therapy. Brain metastases were present in 47% of patients at baseline, including those with active brain metastases. Preliminary Safety AnalysisEnozertinib was well tolerated with mostly Grade 1 or 2 treatment-related adverse events (TRAEs), and no significant off-target toxicities. Most frequent TRAEs included paronychia, diarrhea, and dermatitis acneiform. Only 2 patients discontinued treatment due to TRAEs. Higher rates of dose reductions occurred in the 120 mg cohort compared to the 80 mg cohort. Preliminary Activity AnalysisTumor responses were observed in both the 80 mg and 120 mg cohorts, including in patients with baseline brain ...