Pierre Fabre Laboratories has initiated a Phase I/II clinical trial for PFL-002/VERT-002, a monoclonal antibody designed to degrade c-MET, in patients with non-small cell lung cancer (NSCLC) harboring MET alterations. The first patient has been dosed in this first-in-human, dose-escalation, dose-optimization, and dose-expansion trial.
The open-label, multi-center study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of PFL-002/VERT-002 as a monotherapy. The trial will include patients with MET-dependent tumors, including those who have developed resistance to other treatments.
Significance of MET in NSCLC
NSCLC is the most common type of lung cancer, representing approximately 85% of new lung cancer diagnoses. MET, also known as hepatocyte growth factor receptor (HGFR), is an oncogene driver in specific 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.
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," offering a novel therapeutic approach for patients with MET-driven tumors.
Trial Objectives
The Phase I/II trial will thoroughly assess the safety profile of PFL-002/VERT-002, determine the optimal dosage, and evaluate its effectiveness in patients with NSCLC who have MET alterations. This study represents a significant step forward in exploring new treatment options for this patient population.
