Lung cancer with high c-Met expression ushered in a new breakthrough: Telisotuzumab Vedotin received accelerated approval from the FDA

On 20255 month14, AbbVie announced the development of its antibody conjugate drugTelisotuzumab Vedotin (trade nameEmrelis) officially received accelerated approval from the USFDA For the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with overexpression of the c-Met protein. These patients have all previously received systemic anti-cancer treatments, and Emrelis is currently the only targeted therapy option approved for this population. FDAThis approval is based on the drug’s objective response rate (ORR) and duration of response (DOR) data in clinical studies. Subsequent marketing approval requires further clinical studies to verify the efficacy.

The so-calledc-Met protein is a receptor tyrosine kinase that is abnormally expressed in some lung cancers. Its expression level is related to disease progression and poor prognosis. In this approval, FDA simultaneously approved VENTANA developed by Roche MET(SP44)RxDxImmunohistochemistry (IHC) detection kit, as< With span>Emrelis's companion diagnostic tool, only when the test results show that more than 50% of tumor cells show strong positive staining (3+), the patient will be deemed eligible for treatment.

EmrelisThe essence of the drug is a c-Met targeting antibody-The principle of drug conjugates (ADC) is to precisely transport highly effective cytotoxic drugs through antibodies into tumor cells expressing target proteins, maximizing treatment efficiency and reducing damage to normal tissues. LUMINOSITY Phase II clinical trials are the main basis for this accelerated approval. The study covers 84 NSCLC patients with high expression of c-Met >Patients, data show that the overall response rate of Emrelis reaches 35%, and the median response duration is 7.2 months. In an earlier study, the response rate in patients with a specific EGFR wild-type also reached 34.6%, with a median response rate of DORis extended to 9 months, and the overall survival can reach 14.6 months.

In terms of safety, the adverse reactions of Emrelis are similar to those of common ADC drugs, including peripheral neuropathy, fatigue, loss of appetite, and peripheral edema. Some patients may have grade 3 or grade 4 laboratory index abnormalities, which require close monitoring and treatment by doctors. Currently, the drug's global phase 3 registration trial TeliMET NSCLC-01 is progressing to further verify its long-term efficacy and survival benefit in patients with advanced NSCLC overexpressing c-Met.

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. News release. AbbVie/ May 14, 2025. Accessed May 14, 2025.