On January 26, the CDE website showed that Johnson & Johnson had two innovativeDrug EGFR/c-MET Bispecific Antibody AmivantamabAnti-（amivantamab) andThird-generation EGFR inhibitorsLanreotide Tablets (Lazertinib）The listing applications have been accepted by the drug regulatory authority, and it is speculated that the declared indication is for the combination of the two.Treatment of 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, 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 after platinum-based chemotherapy progression, making it 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 in combination with Lazertinib and chemotherapy for the treatment of osimertinib resistance had reachedDual Primary Endpoint,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%, 12.5 vs 12.8 vs 8.3 months.ThisYesThe first Phase III study to demonstrate a clinically meaningful improvement in PFS with osimertinib as a later-line treatment.In the same month, Johnson & Johnson announced againamivantamabUnitedLazertinib Head-to-Head with Osimertinib in the Treatment of EGFR-Mutant Locally Advanced or Metastatic NSCLC: Phase III MARIPOSA Study Meets Primary EndpointAndOsimertinib Treatment GroupIn comparison,amivantamab+Lazertinib treatment group showed statistically significant and clinically meaningful improvement in PFS, along with a trend toward OS benefit.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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