On the Horizon- New Treatment for NSCLC Patients Targeting cMet Over-Expression

Novel antibody-drug conjugate (ADC) may be coming for relapsed/refractory non-small cell cancer (NSCLC) patients with latest Biologics License Application (BLA) submitted on September 24th for accelerated approval to FDA. Data submitted supports telisotuzumab vedotin (Teliso-V) use in adult NSCLC patients with tumors with wild-type epidermal growth factor receptor (EGFR) nonsquamous histology and with cMet protein over-expression. Teliso-V is first-in-class, cMet protein directed ADC.

Mesenchymal-epithelial transition (MET) factor protooncogene encodes the cMET protein and MET gene alterations are known drive oncogenes in NSCLC. Since the identification of MET as a potential therapeutic target, numerous clinical trials have been performed resulting in availability of MET-targeted therapies with currently six FDA-approved drugs targeting cMET but Teliso-V would be first ADC specifically targeting tumors over-expressing cMET protein.

Teliso-V first received?Breakthrough Therapy Designation by the FDA in 2021 and this BLA is supported by data from Phase 2 LUMINOSITY trial?evaluated under Real-Time Oncology Review (RTOR) program so good news for patients may come soon. Important to note is that global confirmatory Phase 3 is already open and enrolling relapsed/refractory NSCLC patients with cMet over-expression (TeliMET NSCLC-01 trial, NCT04928846).