Research Title: Vebreltinib for Advanced Non-Small Cell Lung Cancer Harboring c-Met Exon 14 Skipping Mutation: A Multicenter, Single-Arm, Phase II KUNPENG Study

    Brief Information:

    Vebreltinib showed promising efficacy and a favorable safety profile in patients with METex14-mutant NSCLC. Cohort 1 comprised 52 patients with advanced NSCLC harboring METex14 skipping mutations. The overall response rate (ORR) evaluated by BIRC reached 75.0%. The median progression-free survival (mPFS) was 14.1 months, and the median overall survival (mOS) was 20.7 months. The disease control rate (DCR) was 96.2%, and the median duration of response (mDoR) was 15.9 months with the median time to response (mTTR) of 1.0 month. The safety profile of Vebreltinib was acceptable and generally manageable, and the most common adverse reactions were Grade 1-2. Vebreltinib demonstrated meaningful clinical benefits across high-risk subgroups, including those with brain metastases, liver metastases, MET amplification, or advanced age (≥75 years). In subgroup analysis, NSCLC patients with brain metastases had an ORR and DCR of 100%. NSCLC patients with concurrent METex14 skipping and MET amplification mutations also achieved an ORR and DCR of 100%. Additionally, for elderly patients (≥75 years old), the ORR was 85.7%, and the DCR was 95.2%. Finally, for patients with liver metastases, the ORR was 66.7%, and the DCR was 100%.