Tepotinib early phase clinical data on NSCLC promising: Merck

September 13, 2019 0 By FM

Merck has presented their results from the phase Ib/II INSIGHT trial for the combination study of investigational therapy tepotinib plus EGFR inhibitor gefitinib for non-small cell lung cancer (NSCLC).

Tepotinib is an investigational oral MET inhibitor drug that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, including both MET exon 14 skipping alterations and MET amplifications, or MET protein overexpression.

The 18-month follow-up data including progression-free survival (PFS) and overall survival (OS) data from the Phase Ib/II INSIGHT was presented at the 2019 World Conference on Lung Cancer (#WCLC19).

Patients with EGFR-mutated locally advanced or metastatic NSCLC with MET protein overexpression or MET gene amplification who had disease progression after receiving an EGFR TKI were included in the study.

These results include updated PFS data as well as the first OS data for patients in both the MET overexpression and MET amplification cohorts of this study. These data will be submitted for future publication in a medical journal, Merck said in a statement.

Merck also announced that Phase II INSIGHT 2 study is now open for enrollment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation and select MET dysregulations. The study will be investigating tepotinib in combination with the tyrosine kinase inhibitor (TKI) osimertinib.

The decision to initiate the INSIGHT 2 study is based on the encouraging findings seen in the Phase Ib/II INSIGHT study.

“The consistency of results across the clinical development programme for tepotinib continues to highlight the potential for this investigational therapy in targeting select NSCLC mutations and alterations that are associated with aggressive tumour behaviour and poor clinical prognosis,” said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck.

“We are committed to progressing tepotinib as part of our precision medicine strategy and our work to deliver new therapeutic options for people living with difficult-to-treat cancers, including NSCLC.”she added.