AbbVie Submits BLA to FDA for Telisotuzumab Vedotin, the First-in-Class cMET ADC, Seeking Approval for Previously Treated cMET-Overexpressing NSCLC

▎Armstrong

On September 27, 2024, AbbVie announced the submission of a new drug application to the FDA for Telisotuzumab Vedotin, a cMET ADC, intended for the treatment of adult patients with previously treated, locally recurrent or metastatic, EGFR wild-type, non-squamous, cMET-overexpressing non-small cell lung cancer.

This marketing application is based on the data from the Phase II clinical trial LUMINOSITY. At this year's ASCO meeting, AbbVie disclosed the latest data from this Phase II clinical trial. Among the 172 patients enrolled, 97.5% had received platinum-based chemotherapy, and 82.0% had been treated with immune checkpoint inhibitors. In 78 evaluable patients with high cMET expression, the ORR was 34.6%, the DCR was 60.3%, the mDOR was 9.0 months, the mPFS was 5.5 months, and the mOS was 14.6 months.

Summary

Telisotuzumab Vedotin will become AbbVie's first self-developed ADC drug. AbbVie is deepening its ADC layout, having acquired Immunogen for $10.1 billion at the end of last year to obtain its FRα ADC drug, Elahere.