Telisotuzumab Vedotin Earns FDA Accelerated Approval in c-MET+ NSCLC

With this decision, telisotuzumab vedotin is the first and only available therapy for this NSCLC subtype.

The FDA has granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis) as a treatment for adults with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) and high c-MET protein expression previously managed wih systemic therapy, according to a press release from the developer, AbbVie.1

With this decision, telisotuzumab vedotin is the first and only available therapy for this NSCLC subtype.

The agency based its decision on data from the phase 2 LUMINOSITY trial (NCT03539536), in which investigators assessed the agent as a treatment for those with previously treated c-MET–positive NSCLC.2

Topline data revealed an overall response rate (ORR) of 35% (95% CI, 24%-46%) and a median duration of response (DOR) of 7.2 months (95% CI, 4.2-12.0) among 84 evaluable patients with high c-MET protein overexpression. According to the FDA, continued approval for telisotuzumab vedotin may be dependent on additional validation of the agent’s clinical benefit in a confirmatory trial.

“We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes. People with c-MET–overexpressing NSCLC have poor prognosis and limited treatment options, and [telisotuzumab vedotin] is a first-in-class antibody drug conjugate [ADC] that can address a critical unmet need for this patient population,” Jonathan Goldman, MD, a professor of medicine and director of Thoracic Oncology Clinical Trials at the University of California, Los Angeles, stated in the press release.1

Safety data showed that the most common adverse effects (AEs) associated with the therapy included peripheral neuropathy, fatigue, diminished appetite, and peripheral edema. Additionally, grade 3/4 laboratory abnormalities included decreased lymphocytes, increased glucose, increased alanine aminotransferase, and elevated gamma glutamyl transferase.

The FDA previously granted breakthrough therapy designation to telisotuzumab vedotin for this patient population in January 2022.3

“[Telisotuzumab vedotin], AbbVie's first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease. Leveraging advanced technology and data science, we are growing our ADC portfolio designed to deliver the right medicines to the right patients in need across a range of difficult-to-treat tumors,” Roopal Thakkar, MD, executive vice president of Research and Development and chief scientific officer at AbbVie, concluded.1

References

1. 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. News release. AbbVie. May 14, 2025. Accessed May 14, 2025. https://tinyurl.com/34atzbsv
2. Study of telisotuzumab vedotin (ABBV-399) in participants with previously treated c-Met+ non-small cell lung cancer. ClinicalTrials.gov. Updated January 19, 2024. Accessed May 14, 2025. https://tinyurl.com/3najfjm2
3. AbbVie announces U.S. FDA granted breakthrough therapy designation (BTD) to telisotuzumab vedotin (Teliso-V) for previously treated non-small cell lung cancer. News release. AbbVie. January 4, 2022. Accessed May 14, 2025.