Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) is approved in the US as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. The chemotherapy-free regimen showed progression-free survival versus osimertinib.
With this milestone, Rybrevant plus Lazcluze becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC. Rybrevant is an EGFR- and MET-directed bispecific antibody that engages the immune system, and Lazcluze is a highly selective, brain-penetrant, third-generation oral EGFR TKI. Rybrevant plus Lazcluze is the only multitargeted regimen that directly targets both common EGFR mutations.
The FDA approval is based on positive results from the phase 3 MARIPOSA study, which showed Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30 per cent compared to osimertinib (median progression-free survival [PFS]: 23.7 months versus 16.6 months) in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The median duration of response (DOR) was nine months longer with Rybrevant plus Lazcluze versus osimertinib (25.8 months versus 16.7 months), a secondary endpoint of the study.
The safety profile of Rybrevant plus Lazcluze was consistent with the profiles of the individual treatments. Venous thromboembolic events (VTE) were observed with the combination. Adverse event (AE) rates were consistent in this arm as compared to other Rybrevant regimens.
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