▎WuXiEdited by Kant Content Team

Johnson & Johnson announced today that the U.S. FDA has approved its bispecific antibody Rybrevant (amivantamab) in combination with the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) oral medication Lazcluze (lazertinib) forFirst-line treatment confirmed by FDA-approved testing in the United StatesEGFRAdult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring exon 19 deletions or the L858R substitution mutation in exon 21.Previous trial results showed that, compared with the active control drug, the combination therapy of Rybrevant and Lazcluze reduced the risk of disease progression or death by 30%.

This approval by the U.S. FDA is primarily based on the positive results of the MARIPOSA Phase 3 clinical study, which examinedRybrevant and Lazcluze Combination TherapyCompared with the active control TKI drug Tagrisso, used for first-line treatmentEGFREfficacy and safety in patients with locally advanced or metastatic NSCLC with exon 19 deletions or L858R substitution mutations in exon 21. Analysis shows that Rybrevant and Lazcluze reduce the risk of disease progression or death by 30% compared to the active control drug.The median progression-free survival (PFS) for patients in the combination therapy group and the active comparator group was 23.7 months and 16.6 months, respectively.In addition,The median DOR of the combination therapy group was 9 months longer than that of the active control drug (25.8 months vs 16.7 months)., which was the secondary endpoint of the study.

Combination TherapyThe safety profile is consistent with the known safety of each component.。

RybrevantIt is a humanized EGFR/MET bispecific antibody.It has multiple mechanisms of anticancer action, not only blocking EGFR and MET-mediated signal transduction but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications.RybrevantObtained FDA approval in the United States in May 2021Accelerated Approval, for the treatment detected by FDA-approved testsEGFRAdult patients with locally advanced or metastatic NSCLC who have exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy.Lazcluze is a highly selective, third-generation oral EGFR TKI capable of penetrating the blood-brain barrier.。