Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab.

Amivantamab is a bispecific antibody designed to target EGFR and mesenchymal epithelial transition factor (MET) mutated tumours.

The FDA submission is based on results from the monotherapy arm of Janssen’s phase I CHRYSALIS study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a third generation EGFR tyrosine kinase inhibitor (TKI).

An overall response rate (ORR) of 36% was observed in all NSCLC patients and 41% in patients with previously treated with platinum-based chemotherapy.

In addition, the median duration of response for all evaluable patients was ten months and seven months for patients previously treated with platinum-based chemoterhapy.

The median progression-free survival was 8.3 months for all patients and 8.6 months for patients previously treated with chemotherapy.

NSCLC patients with EGFR Exon 20 mutations are generally insensitive to approved EGFR TKI treatments, which means that these patients are met with a worse prognosis compared to patients with more common EGFR mutations.

"This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options," said Peter Lebowitz, global therapeutic area head, oncology, Janssen Research & Development.

"We are committed to the development of therapies like amivantamab that progress precision medicine and target specific pathways, and to providing access through expanded access programmes,” he added.