Janssen's EGFR/c-Met Bispecific Antibody Rybrevant Combined with Third-Generation EGFR TKI Lazertinib Receives FDA Approval for First-Line Treatment of EGFR-Mutated NSCLC
Johnson & Johnson
Medical Device R&D and Manufacturer
On August 20, Johnson & Johnson announced its EGFR/c-Met bispecific antibody Rybrevant (amivantamab-vmjw,Amivantamab) + The third-generation EGFR inhibitor Lazcluze (lazertinib) combination regimen has been approved by the U.S. FDA for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation. This is the first and only chemotherapy-free regimen that has demonstrated superior progression-free survival (PFS) compared to osimertinib.
The FDA approval was based on the positive results of the Phase III MARIPOSA study, which head-to-head compared the efficacy and safety of Rybrevant + Lazertinib combination regimen with osimertinib as first-line treatment in high-risk EGFR-mutated locally advanced or metastatic NSCLC patients. The results showed that Rybrevant + Lazertinib reduced the risk of disease progression or death by 30% (PFS: 23.7 months vs 16.6 months). In terms of secondary endpoints, Rybrevant + Lazertinib extended the median duration of response (DOR) by 9 months compared to the osimertinib group (25.8 months vs 16.7 months).
In terms of safety, the combination of Rybrevant and Lazertinib showed a safety profile consistent with each monotherapy, with most adverse events being Grade 1 or Grade 2.
Rybrevant is a fully human bispecific antibody targeting EGFR and MET, with immune cell-directed activity. It has been approved as a monotherapy in the United States, Europe, and other global markets for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. This approval marks the second new indication for Rybrevant this year, following the FDA's approval in March for its use in combination with chemotherapy (carboplatin-pemetrexed) as a first-line treatment for patients with locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations.
Lazertinib is an orally administered third-generation brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. It was not previously marketed.
Jennifer Taubert, Executive Vice President of Johnson & Johnson and Global Chair of Innovative Medicine, stated: "With over thirty years of oncology innovation experience, Johnson & Johnson is uniquely positioned. Rybrevant in combination with Lazertinib sets a new standard in first-line treatment for advanced NSCLC, and we look forward to bringing this new chemotherapy-free treatment option to patients."
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