Pierre Fabre Laboratories has announced the dosing of the first patient in a Phase I/II clinical trial evaluating PFL-002/VERT-002, a novel monoclonal antibody designed to degrade c-MET, in patients with non-small cell lung cancer (NSCLC) harboring MET alterations. This first-in-human study marks a significant step in exploring a new therapeutic avenue for NSCLC patients with these specific genetic profiles.
The Phase I/II trial is an open-label, multi-center study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of PFL-002/VERT-002 when administered as a monotherapy. The trial will enroll patients with MET-dependent tumors, including those who have developed resistance to other treatments.
Targeting MET Alterations in NSCLC
NSCLC represents approximately 85% of all newly diagnosed lung cancer cases. MET, also known as hepatocyte growth factor receptor (HGFR), is an oncogene driver in subsets of NSCLC patients. MET exon 14 skipping mutations and MET amplification can act as primary oncogenic drivers, while MET amplification can also emerge as a resistance mechanism to certain targeted therapies.
A Novel Mechanism of Action
PFL-002/VERT-002 stands out due to its unique mechanism of action. According to Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories, the drug "targets a clinically validated oncogenic driver with a unique and differentiated mechanism of action, triggering the degradation of the c-MET oncogene." This approach offers a potential new treatment strategy for patients with MET-driven tumors.
By inducing the degradation of c-MET, PFL-002/VERT-002 aims to overcome the limitations of existing therapies and provide a more effective treatment option for patients with NSCLC and MET alterations.
