Merck Introduces Breakthrough Calderasib (MK-1084) Therapy for Treating KRAS G12C-Mutant Non-Small Cell Lung Cancer
Merck has introduced calderasib (MK-1084) for the treatment of newly diagnosed metastatic KRAS G12C-mutant non-small cell lung cancer (NSCLC).
Calderasib is an investigational oral KRAS G12C inhibitor designed to selectively target the KRAS G12C mutation, a key oncogenic driver in a subset of non-small cell lung cancers. The therapy is being developed for use in combination with pembrolizumab as a first-line treatment for patients with metastatic KRAS G12C-mutant NSCLC.
The Breakthrough Therapy Designation is supported by results from the Phase 2 KANDLELIT-001 study, in which calderasib, in combination with pembrolizumab, demonstrated promising antitumour activity and a manageable safety profile in patients with previously untreated metastatic KRAS G12C-mutant NSCLC. The designation is intended to accelerate the development and regulatory review of therapies that may offer substantial improvements over existing treatment options.
KRAS G12C-mutant non-small cell lung cancer is a molecular subtype of NSCLC caused by mutations in the KRAS gene that promote uncontrolled tumour growth. NSCLC accounts for approximately 85% of all lung cancer cases, and patients with metastatic disease often have limited treatment options despite recent advances in targeted therapies and immunotherapy.
Calderasib has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of certain patients with newly diagnosed metastatic KRAS G12C-mutant NSCLC. The therapy is currently being evaluated in ongoing clinical studies to further assess its efficacy and safety as a first-line treatment option.
