Johnson & Johnson’s Innovative Medicine (formerly Janssen) reported that the combination of amivantamab (Rybrevant®) and lazertinib (Leclaza® in Korea, Lazcluze® internationally), developed by Yuhan Corporation, provides a survival benefit of over one year compared with osimertinib (Tagrisso®) in patients with EGFR-mutated non-small cell lung cancer (NSCLC). The combination also significantly reduced EGFR- and MET-related resistance, highlighting its potential for long-term disease control.
The findings come from the latest analysis of the global phase 3 MARIPOSA trial, comparing the combination as first-line therapy against osimertinib monotherapy. Blood-based next-generation sequencing (NGS) showed that MET amplification occurred in 3.4% of combination-treated patients versus 13.1% in the osimertinib arm, while secondary EGFR mutations (e.g., C797S) emerged in just 1.4% versus 7.6%. Early progression due to MET amplification was rare in the combination group. Analysis of tumor heterogeneity using the Shannon Diversity Index also suggested that the combination reduced clonal complexity, potentially limiting tumor evolution.
These resistance findings build on earlier data from the European Lung Cancer Congress (ELCC) 2025, where a median follow-up of 37.8 months showed the combination reduced the risk of death by 25%, translating to an OS benefit of over one year. Researchers emphasized that the dual effect of prolonging survival while suppressing resistance could establish the regimen as a new treatment paradigm for EGFR-mutant NSCLC. Regulatory and Commercial Status:
Lazertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), was developed by Yuhan, licensed to Janssen in 2018, and approved in Korea in 2021 as the country’s 31st domestically developed new drug. The combination of lazertinib and amivantamab is now approved in seven countries: the U.S., Europe, South Korea, the U.K., Canada, Japan, and China, with regulatory processes ongoing in Australia, Brazil, and other markets. Germany has recognized its clinical value, with insurance coverage expected in early 2026.
Commercial Performance:
In the first half of 2025, global sales of the combination reached $320 million, nearly tripling from $116 million in the same period last year, with 80% of revenue generated in the U.S. market. Yuhan has also received milestone payments for U.S. and Japan approvals, with Europe and China payments expected later this year, in addition to royalties on future sales.
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