FDA grants breakthrough therapy designation to telisotuzumab vedotin for lung cancer
The FDA granted breakthrough therapy designation to telisotuzumab vedotin for treatment of certain patients with non-small cell lung cancer.
The designation applies to use of the agent by patients with advanced or metastatic EGFR wild-type, nonsquamous NSCLC with high levels of c-Met overexpression whose disease progressed on or after platinum-based therapy.
Telisotuzumab vedotin (AbbVie) is an investigational antibody-drug conjugate that targets c-Met, a receptor tyrosine kinase overexpressed in NSCLC and other tumor types. No FDA-approved therapies are specifically indicated for patients with c-Met-overexpressing NSCLC.
The ongoing phase 2 LUMINOSITY study is designed to identify the target NSCLC populations that overexpress c-Met best suited for telisotuzumab vedotin monotherapy in the second- or third-line settings, and then to expand the groups to further evaluate efficacy in the selected populations.
Overall response rate per central review among patients with at least 12 weeks of follow-up serves as the primary endpoint. Previously reported interim analysis results showed ORRs of 53.8% among patients with EGFR wild-type nonsquamous NSCLC with high c-Met expression and 25% among those with intermediate c-Met expression.