AbbVie's c-MET-Targeted ADC Telisotuzumab Vedotin Granted Breakthrough Therapy Designation in China for NSCLC

In China, the incidence and mortality rates of lung cancer rank first among all malignant tumors. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases, and most patients are already in advanced stages at diagnosis, usually with a poor prognosis. According to literature reports, c-Met protein overexpression has been found in about 25% of advanced EGFR wild-type NSCLC patients. c-Met is a receptor tyrosine kinase that is overexpressed in various tumors, including non-small cell lung cancer, and is associated with poor patient prognosis.

Teliso-V is a first-in-class investigational antibody-drug conjugate targeting the c-MET protein.（ADC）, for tumor patients with c-Met overexpression. C-Met is a receptor tyrosine kinase that is overexpressed in many solid tumors, including NSCLC. In the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868), its efficacy and safety as a monotherapy for previously treated c-Met overexpressing NSCLC patients will be further evaluated.

Currently, there is no approved cancer therapy specifically targeting c-Met overexpression in NSCLC patients.Teliso-V has not been approved by any regulatory agency.

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In November 2023, AbbVie announced the primary results of the single-arm Phase 2 LUMINOSITY trial, which evaluated the efficacy of Teliso-V in treating patients with c-Met protein overexpression, advanced/metastatic EGFR wild-type non-squamous NSCLC. The analysis showed that the LUMINOSITY trial demonstrated positive clinical benefits at key endpoints.

Specifically, according to the trial results analyzed by Independent Central Review (ICR),The overall response rates for patients with high and moderate c-Met expression were 35% and 23%, respectively.. In addition, other endpoints showed meaningful clinical outcomes, including patients with high and moderate c-Met expression.The median durations of response were 9 months and 7.2 months, and the median overall survival times were 14.6 months and 14.2 months, respectively.The safety profile of Teliso-V was consistent with previous results.

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