AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company in the U.S., has announced the filing of a first Biologics License Application (BLA) for telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate (ADC) targeting tumors that overexpress the c-Met protein. The U.S. Food and Drug Administration (FDA) has accepted the filing for the initial indication of adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild-type, nonsquamous non-small cell lung cancer (NSCLC) exhibiting c-Met protein overexpression.
The c-Met protein, a receptor tyrosine kinase, is overexpressed in approximately 25% of patients with advanced nonsquamous NSCLC who have no EGFR mutations. The BLA filing is supported by data from the ongoing Phase II LUMINOSITY trial (Study M14-239). AbbVie has also initiated the global confirmatory Phase III TeliMAT NSCLC-01 study to evaluate Teliso-V as a monotherapy in patients with previously treated c-Met overexpressing NSCLC. In late 2023, AbbVie released topline data from the Phase II study for Teliso-V, showing overall response rates (ORR) of 35% and 23% in patients with high and intermediate levels of c-Met, respectively. The median duration of response (DOR) was 9 months and 7.2 months, and median overall survival (OS) was 14.6 months and 14.2 months for the respective patient groups.
Previously, AbbVie’s Teliso-V was granted breakthrough therapy designation (BTD) by the U.S. FDA and, more recently in June this year, by the National Medical Products Administration in China. Jiangsu Hengrui Pharmaceutical, among other global competitors, is also developing a c-Met targeted ADC.- Flcube.com
