Tanja Obradovic: New Treatment for NSCLC Patients Targeting cMet Over-Expression
Tanja Obradovic shared a post on LinkedIn:
“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).
BLA submitted for accelerated approval to FDA for telisotuzumab vedotin (Teliso-V) 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.”
Source: Tanja Obradovic/LinkedIn
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Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.
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