Telisotuzumab Vedotin Approved for Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With High c-Met Protein Overexpression

According to AbbVie, the United States Food and Drug Administration (FDA) granted accelerated approval to telisotuzumab vedotin for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression, who had received prior systemic therapy. High c-Met overexpression is defined as ≥ 50% of tumor cells with 3+ staining, as determined by an FDA-approved test.

Telisotuzumab vedotin is a c-Met–directed antibody-drug conjugate and is the first, and only, treatment approved for this specific patient population. This regulatory decision was based upon data from the phase 2 LUMINOSITY trial. This trial included 84 patients with advanced high c-Met protein–overexpressing non-squamous, EGFR-wildtype, non-small cell lung cancer who had received ≤ 2 prior lines of therapy including ≤ 1 line of systemic chemotherapy. Patients received 1.9 mg/kg telisotuzumab vedotin once every 2 weeks.

Among the patients with c-Met high overexpression, the objective response rate was 35.0% and the median duration of response was 7.2 months. The most common adverse events occurring in ≥ 20% of patients were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common grade 3/4 laboratory abnormalities occurring in ≥ 2% of patients were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.

The global, randomized, phase 3, confirmatory TeliMET NSCLC-01 trial, evaluating telisotuzumab vedotin monotherapy among patients with previously treated c-Met overexpressing non-small cell lung cancer, is currently enrolling.

Source:

AbbVie. U.S. FDA Approves EMRELIS™ (telisotuzumab vedotin-tllv) for Adults With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) With High c-Met Protein Overexpression. Accessed May 14, 2025. https://news.abbvie.com/2025-05-14-U-S-FDA-Approves-EMRELIS-TM-telisotuzumab-vedotin-tllv-for-Adults-With-Previously-Treated-Advanced-Non-Small-Cell-Lung-Cancer-NSCLC-With-High-c-Met-Protein-Overexpression

Camidge R, Bar J, Horinouchi H, et al. Telisotuzumab vedotin monotherapy in patients with previously treated c-Met protein–overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the phase II LUMINOSITY trial. J Clin Oncol. Published June 6, 2024. doi: 10.1200JCO.24.00720