▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced that the European Commission hasApproval of Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) as a first-line treatment for patients with epidermal growth factor receptor (EGFR) Adult patients with advanced non-small cell lung cancer (NSCLC) harboring exon 19 deletions (ex19del) or exon 21 L858R mutations.

The approval by the European Commission was based on the results of the Phase 3 clinical trial MARIPOSA. The study evaluated Lazcluze in combination with Rybrevant, compared to the active control osimertinib, as a first-line treatment for patients carrying the aforementionedEGFREfficacy in patients with mutant NSCLC. The analysis shows,Rybrevant in combination with Lazcluze reduced 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. Additionally, the median duration of response (DOR) in the combination therapy group was 9 months longer than in the active comparator group (25.8 months vs. 16.7 months).

On January 7, 2025, Johnson & Johnson announced positive overall survival (OS)Top-line Results, showing that Lazcluze in combination with Rybrevant achieved the pre-specified secondary endpoint, providing a statistically significant and clinically meaningful improvement in OS compared to the existing standard of care. These landmark OS data will be presented at an upcoming medical conference.

Rybrevant is a humanized EGFR/MET-targeted 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 those with activating and drug-resistant mutations.EGFR/METMutations and amplifications in tumors. Rybrevant received accelerated approval from the U.S. FDA in May 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.EGFRAdult 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 tyrosine kinase inhibitor capable of crossing the blood-brain barrier.

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