Janssen, the pharmaceutical division of Johnson & Johnson, has submitted a marketing authorisation application to the European Medicines Agency (EMA) for approval of its epidermal growth factor receptor (EGFR)-targeting bispecific antibody amivantamab.
The company is seeking approval for the drug as a treatment for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed after platinum-based chemotherapy.
Amivantamab is designed to target EGFR and mesenchymal epithelial transition factor (MET) mutations, by directing immune cells to target tumours with activating and resistance EGFR and MET mutations and amplifications.
The EMA submission is based on data from Janssen’s phase I CHRYSALIS study, which evaluated the safety and efficacy of amivantamab as a monotherapy and in combinations with lazertinib – a third generation EGFR tyrosine kinase inhibitor – in advanced NSCLC patients.
Findings from the study showed an overall response rate of 36% in all evaluable patients and 41% in the 29 evaluable patients who had previously been treated with platinum-based chemotherapy.
The median duration of response for all evaluable patients was ten months, and seven months for patients previously treated with platinum-based chemotherapy.
“Lung cancer is the biggest cause of cancer death in Europe and has one of the lowest five-year survival rates for patients with cancer. Given this significant unmet need, we are committed to improving outcomes for patients diagnosed with this complex disease,” said Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson.
“With [this] submission for amivantamab, we are one step closer to our goal of advancing novel therapeutics that will transform the trajectory of some of the most challenging diseases of our time, including lung cancer,” he added.
