Amivantamab: New approval for metastatic non-small cell lung cancer

Abstract

Lung cancer is one of the most public health problems in many countries,including Thailand. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. The most important risk factor of lung cancer is smoking. Amivantamab is a fully human bispecific monoclonal antibody directed against epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET). Amivantamab binds to the extracellular domains of both EGFR and MET, thereby blocks their interactions with the cognate ligands, resulting in the disruption of these signaling pathways. Amivantamab is being developed for the treatment of adult patients with locally advanced or metastatic NSCLC harbouring EGFR Exon 20 insertion (Ex20ins) mutations, whose disease has progressed on or after platinum-based chemotherapy. The recommended dose of amivantamab is 1050 mg and 1400 mg in patients weighing < 80 kg and ≥ 80 kg, respectively, weekly for every 4 weeks, then every 2 weeks until disease progression or unacceptable toxicity. Serious adverse reactions reported in ≥ 2% of patients: pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia and muscular weakness. The most common (incidence ≥ 20%) adverse reactions were rash, infusion- related reaction, paronychia, musculoskeletal pain, dyspnea, and fatigue. Furthermore,there are unnecessary to adjust dose of amivantamab in patients with impaired renal and hepatic function in mild to moderate grade, but no study in severe grade. Moreover, age>65 years or <65 years are not affected on efficacy and safety in the current study trial. Amivantamab was approved by United States Food and Drug Administration as a first drug of choice in patients with locally advanced or metastatic NSCLC with EGFR Ex20ins mutation.