The Janssen Pharmaceutical Companies of Johnson & Johnson has filed a Type II extension of indication application with the European Medicines Agency (EMA) seeking approval for Rybrevant (amivantamab) for advanced non-small cell lung cancer (NSCLC).

The asset is intended to be used along with lazertinib for the first-line treatment of adult NSCLC patients with common epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

A fully-human EGFR-MET [mesenchymal epithelial transition] bispecific antibody, amivantamab has immune cell-directing activity.

It acts on tumours with activating and resistance EGFR mutations, as well as MET mutations and amplifications.

The submission is based on data from the Phase III MARIPOSA clinical trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the amivantamab combination regimen versus osimertinib.

The randomised study enrolled 1,074 subjects and compared amivantamab plus lazertinib to osimertinib and versus lazertinib alone.

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PFS is the trial’s primary endpoint. Overall survival, overall response rate, duration of response, second PFS and intracranial PFS comprise the secondary endpoints.

The amivantamab and lazertinib combination demonstrated a safety profile in line with previous studies with most adverse events being Grade 1 or 2.

In December last year, Janssen filed a marketing authorisation application with the EMA for lazertinib plus amivantamab based on the MARIPOSA study.

The development comes after Janssen sought US Food and Drug Administration approval for a Rybrevant combination regimen for locally advanced or metastatic NSCLC.

In December 2021, the European Commission granted conditional marketing authorisation for amivantamab to treat advanced NSCLC in adults with EGFR exon 20 insertion mutations, post-failure of platinum-based treatment.

Amivantamab became the first approved treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for NSCLC.

Janssen research and development solid tumours clinical development vice-president Kiran Patel stated: “The submission is a testament to our steadfast dedication to advancing innovative therapies for those who need them most, now and in the future.

“Pending approval, this novel combination of amivantamab and lazertinib has the potential to transform first-line treatment for patients with EGFR-mutated NSCLC.”