Telisotuzumab vedotin, sold under the brand name Emrelis, is an antibody drug conjugate used for the treatement of non-small cell lung cancer. Telisotuzumab vedotin is a c-Met-directed antibody and microtubule inhibitor conjugate. It was developed by AbbVie. The most common adverse reactions include peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common grade 3 or 4 laboratory abnormalities include decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium. Telisotuzumab vedotin was approved for medical use in the United States in May 2025. The US Food and Drug Administration considers it to be a first-in-class medication.
Medical uses Telisotuzumab vedotin is indicated for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met protein overexpression who have received a prior systemic therapy.
Adverse effects The most common adverse reactions include peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common grade 3 or 4 laboratory abnormalities include decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.
History Efficacy was evaluated in the LUMINOSITY study (NCT03539536), a multi-center, open label, multi-cohort trial. The trial included 84 participants with epidermal growth factor receptor wild-type, non-squamous non-small cell lung cancer with high c-Met protein overexpression who had received prior systemic therapy. The benefits and side effects of telisotuzumab vedotin were evaluated in one clinical trial of 168 participants with non-squamous, EGFR wild-type non-small cell lung cancer with high c-Met protein overexpression who had received one to three prior systemic treatments. The US Food and Drug Administration (FDA) granted accelerated approval to telisotuzumab vedotin based predominantly on evidence from one clinical trial (LUMINOSITY/NCT03539536) of 168 participants with non-squamous, epidermal growth factor receptor (EGFR) wild-type non-small cell lung cancer with c Met protein overexpression who had received prior systemic therapy, including 19 participants from the United States. The trial was conducted at 119 sites across 23 countries in North America, Europe, Asia, the Middle East, and Oceania. There were 84 participants with non-squamous, EGFR wild-type non-small cell lung cancer with high c-Met protein overexpression who had received prior systemic therapy. The FDA granted the application for telisotuzumab vedotin priority review and breakthrough therapy designations.
Society and culture
Legal status Telisotuzumab vedotin was approved for medical use in the United States in May 2025.
Names Telisotuzumab vedotin is the international nonproprietary name. Telisotuzumab vedotin is sold under the brand name Emrelis.
References
Further reading Camidge, D. Ross; Barlesi, Fabrice; Goldman, Jonathan W.; Morgensztern, Daniel; Heist, Rebecca; Vokes, Everett; et al. (February 2023). "Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein–Expressing Non–Small-Cell Lung Cancer". Journal of Clinical Oncology. 41 (5): 1105–1115. doi:10.1200/JCO.22.00739. ISSN 0732-183X. PMC 9928626. PMID 36288547. Camidge, D. Ross; Barlesi, Fabrice; Goldman, Jonathan W.; Morgensztern, Daniel; Heist, Rebecca; Vokes, Everett; et al. (January 2022). "A Phase 1b Study of Telisotuzumab Vedotin in Combination With Nivolumab in Patients With NSCLC". JTO Clinical and Research Reports. 3 (1) 100262. doi:10.1016/j.jtocrr.2021.100262. PMC 8717236. PMID 35005654. Fujiwara, Yutaka; Kenmotsu, Hirotsugu; Yamamoto, Noboru; Shimizu, Toshio; Yonemori, Kan; Ocampo, Christopher; et al. (April 2021). "Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors". Cancer Medicine. 10 (7): 2350–2358. doi:10.1002/cam4.3815. ISSN 2045-7634. PMC 7982615. PMID 33675179. Strickler, John H.; Weekes, Colin D.; Nemunaitis, John; Ramanathan, Ramesh K.; Heist, Rebecca S.; Morgensztern, Daniel; et al. (November 2018). "First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody–Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors". Journal of Clinical Oncology. 36 (33): 3298–3306. doi:10.1200/jco.2018.78.7697. PMID 30285518. Waqar, Saiama N.; Redman, Mary W.; Arnold, Susanne M.; Hirsch, Fred R.; Mack, Philip C.; Schwartz, Lawrence H.; et al. (May 2021). "A Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753)". Clinical Lung Cancer. 22 (3): 170–177. doi:10.1016/j.cllc.2020.09.013. ISSN 1525-7304. PMC 8044254. PMID 33221175.
External links Clinical trial number NCT03539536 for "Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer" at ClinicalTrials.gov

