Johnson & Johnson Submits New Drug Application in China for Amivantamab, an EGFR/c-MET Bispecific Antibody, for Advanced NSCLC

On October 26, the CDE website showed that Johnson & Johnson's amivantamab injection (amivantamab) marketing application was accepted by the NMPA, with a registration category of 2.2.

Amivantamab is a bispecific antibody that targets EGFR resistance mutations, MET mutations, and amplifications. It can simultaneously bind to the extracellular structures of EGFR and c-Met, block the binding of ligands to EGFR and MET, promote receptor degradation, and trigger antibody-dependent cellular cytotoxicity.

In May 2021, amivantamab received accelerated FDA approval for the treatment of patients with advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy. It is the world's first approved EGFR/c-MET bispecific antibody. Since this year, amivantamab has achieved positive results in several Phase III clinical trials.

On July 17, Johnson & Johnson announced positive results from the confirmatory Phase III PAPILLON study of amivantamab in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of newly diagnosed EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC patients. The study met its primary endpoint of PFS, with patients receiving the combination therapy achieving a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to those on chemotherapy alone.

On September 6, Johnson & Johnson announced that the Phase III MARIPOSA-2 study of amivantamab combined with Lazertinib and chemotherapy for the treatment of osimertinib resistance met dual primary endpoints. Compared with the chemotherapy-alone group, both experimental groups showed statistically significant and clinically meaningful improvements in PFS. This is the first Phase III study to demonstrate clinically meaningful PFS improvement in post-osimertinib treatment.

On September 28, Johnson & Johnson announced again that the Phase III MARIPOSA study of amivantamab combined with Lazertinib versus osimertinib for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC met its primary endpoint. Compared with the osimertinib treatment group, the amivantamab + Lazertinib treatment group showed statistically significant and clinically meaningful improvement in PFS, along with a trend toward OS benefit.

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