Through global collaboration with multinational pharmaceutical companies, a domestically developed anticancer drug has once again been published in the world-renowned New England Journal of Medicine (NEJM). On September 7, the final analysis of the phase 3 MARIPOSA trial in non-small cell lung cancer (NSCLC), with Professor Byoung Chul Cho of Yonsei University College of Medicine as the corresponding author, appeared in NEJM.
This marks the third oncology paper from Korea published in NEJM, and notably, the first time a homegrown drug has been featured twice in succession. Following the 2021 publication of a study on lazertinib monotherapy, the new paper reports on the combination therapy of amivantamab plus lazertinib.
The global phase 3 trial enrolled 1,074 patients with EGFR-mutant advanced NSCLC, comparing Janssen’s EGFR-MET bispecific antibody amivantamab (Rybrevant) plus Yuhan’s third-generation tyrosine kinase inhibitor lazertinib (marketed as Leclaza in Korea, Lazcluze in the U.S.) with osimertinib (Tagrisso). Korean investigators played a key role in the study.
The amivantamab-lazertinib combination significantly improved overall survival compared to Tagrisso. With a median follow-up of 37.8 months, the regimen reduced the risk of death by 25% (HR 0.75). Three-year overall survival was 60% for the combination versus 51% for osimertinib.
This regimen has already been approved by both the U.S. FDA and the EMA as a first-line treatment for EGFR-mutant advanced NSCLC. With its publication in NEJM, lazertinib’s global profile is expected to grow further. Professor Cho commented that the combination marks a new milestone in the treatment paradigm for EGFR-mutant lung cancer.
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