The FDA approved telisotuzumab vedotin-tllv (Emrelis; AbbVie) to treat adults with locally advanced or metastatic, non-squamous non–small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic treatment.1
Also referred to as Teliso-V, telisotuzumab vedotin is an antibody-drug conjugate (ADC) that targets surface c-MET expression, which affects roughly a quarter of patients with EGFR wild-type NSCLC. Telisotuzumab vedotin is now the only approved treatment for this indication, according to an AbbVie news release, providing a new option for these patients based on efficacy and safety data from the ongoing phase 2 LUMINOSITY trial (NCT03539536).
The FDA approved telisotuzumab vedotin based on data from the ongoing LUMINOSITY trial. | Image credit: chrisdorney – stock.adobe.com
“Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working,” Upal Basu Roy, PhD, MPH, executive director of research at the LUNGevity Foundation, said in a news release. “This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade.”
High c-Met protein overexpression happens when at least 50% of tumor cells have strong staining (3+). The LUMINOSITY trial demonstrated a 35% overall response rate (95% CI, 24-46) and a duration of response of 7.2 months on average (95% CI, 4.2-12) among the 84 patients with high c-Met protein overexpression who took telisotuzumab vedotin.
The most common adverse events among the cohort were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common Grade 3 or 4 laboratory abnormalities included decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.
“Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s),” the news release said.
References
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. AbbVie. News release. May 14, 2025. 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
