AbbVie's Telisotuzumab Vedotin (Teliso-V) Becomes World’s First c-Met ADC Approved by FDA for NSCLC

On May 14, AbbVie announced the antibody-drug conjugate (ADC) Telisotuzumab Vedotin targeting c-Met.（Teliso-V）Has been approved by the U.S. FDA for marketing, indicated for previously treated locally advanced or metastatic epidermal growth factor receptor（EGFR）Wild-type, c-Met protein high-expression non-squamous non-small cell lung cancer（NSCLC）Adult patients.

Teliso-V is the world's first approved c-Met ADC, as well as the first approved first-in-class therapy specifically targeting c-Met overexpression in NSCLC patients.

ComeSource:AbbVie Official Website

Lung cancer is a common type of malignant tumor, among which NSCLC accounts for about 85% of all lung cancers. Most patients are already in the advanced stage at the time of diagnosis and usually have a poor prognosis. C-Met is a receptor tyrosine kinase that is overexpressed in many solid tumors, including NSCLC.

Teliso-V is a potential "first-in-class" ADC targeting c-Met, which has previously been granted Breakthrough Therapy designation by the FDA and included in the list of breakthrough treatments by the CDE. The approval of this product in the United States was supported by the Phase II LUMINOSITY trial.（M14-239）Data support, this trial aims to evaluate the safety and efficacy of Teliso-V in c-Met overexpressed NSCLC population.

2024 American Society of Clinical Oncology（ASCO）Data released at the conference showed:

• Objective Response Rate of Teliso-V in the Total Population, c-Met High Expression Population, and Moderate Expression Population（ORR）28.6%, 34.6%, and 22.9%, respectively, disease control rate（DCR）59.0%, 60.3%, and 57.8%, respectively;

• Median Duration of Response（mDOR）8.3 months, 9.0 months, and 7.2 months, respectively;

• Median Progression-Free Survival（mPFS）5.7 months, 5.5 months, and 6.0 months, respectively;

• Median Overall Survival（mOS）14.5 months, 14.6 months, and 14.2 months, respectively.

In terms of safety, treatment-related adverse events of any grade in the study（TRAEs）The incidence rate was 81.4%, and the incidence rate of Grade ≥3 TRAE was 27.9%. The most common TRAEs were peripheral sensory neuropathy.（30.2%）, Peripheral Edema（16.3%）And Fatigue（14%）etc.

Currently, AbbVie is further exploring the efficacy of Teliso-V in c-MET overexpressed, EGFR wild-type, previously treated locally advanced/metastatic non-squamous NSCLC patients in the Phase III TeliMET NSCLC-01 study.

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