Johnson & Johnson Submits NDA in China for EGFR/c-MET Bispecific Antibody Amivantamab in Combination with Lazertinib for EGFR-Mutated NSCLC

On January 26, the CDE website showed that the marketing applications of two innovative drugs from Johnson & Johnson, the EGFR/c-MET bispecific antibody Amivantamab and the third-generation EGFR inhibitor Lazertinib, were accepted by the NMPA. It is speculated that the indication applied for is the combination therapy of both drugs to treat patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

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, blocking the binding of ligands to EGFR and MET, promoting receptor degradation, and triggering 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.

In September 2023, Johnson & Johnson announced that the Phase III MARIPOSA-2 study of amivantamab combined with Lazertinib and chemotherapy for the treatment of osimertinib resistance had achieved dual primary endpoints. Amivantamab + chemotherapy and amivantamab + chemotherapy + Lazertinib reduced the risk of disease progression or death by 52% and 56%, respectively. The mPFS, ORR, and median icPFS for amivantamab + chemotherapy vs amivantamab + chemotherapy + Lazertinib vs chemotherapy were: 6.3 vs 8.3 vs 4.2 months, 64% vs 63% vs 36%, and 12.5 vs 12.8 vs 8.3 months, respectively. This is the first Phase III study to demonstrate a clinically meaningful improvement in PFS for post-osimertinib treatment.

In the same month, 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 a statistically significant and clinically meaningful improvement in PFS, along with a trend toward OS benefit.

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