Home Lazertinib Approved in China for First-Line Treatment of EGFR-Mutated NSCLC in Combination with Amivantamab

Lazertinib Approved in China for First-Line Treatment of EGFR-Mutated NSCLC in Combination with Amivantamab

Jul 31, 2025 00:03 CST Updated 00:03
Johnson & Johnson

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July 30,The official website of China's National Medical Products Administration shows that Johnson & Johnson's third-generation EGFR inhibitorLanreotide in ChinaApproved, in combination with EGFR/c-Met bispecific antibodyAmivantamabFor first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose epidermal growth factor receptor (EGFR) has exon 19 deletions or exon 21 L858R substitution mutations.

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This approval is mainly based on the positive results of the Phase III MARIPOSA study, whichEvaluatedAmivantamab+Lazertinib versus Osimertinib orEfficacy and Safety of Lazertinib as First-Line Treatment for EGFR-Mutated Locally Advanced or Metastatic NSCLC.

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Study Design

Previously published inThe research data from the NEJM shows that the trial has reached its primary endpoint:Compared with the osimertinib monotherapy group, the median progression-free survival (PFS) was significantly prolonged in the amivantamab + lazertinib group (23.7 months vs 16.6 months; HR 0.70; 95% CI 0.58-0.85; P<0.001).

2025 ELCC ConferenceThe latest disclosed overall survival (OS) data show that, at a median follow-up of 37.8 months,Compared with the osimertinib monotherapy group, the median overall survival (OS) in the amivantamab + lazertinib groupExtended by at least 12 months(Not reached vs 36.7 months; HR 0.75; 95% CI 0.61-0.92; P<0.005).

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OS Data

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OS Subgroup Data

Other key data:1)Time to Symptomatic Progression (TTSP): The combination group and the osimertinib group were respectively:43.6 months vs 29.3 months (HR=0.69; P<0.001).2)Intracranial Progression-Free Survival (icPFS): Median icPFS: Combination group and Osimertinib group, respectively25.4 months vs 22.2 months (HR=0.79; P=0.07); 3-year icPFS rate: Combination group and Osimertinib group, respectively36% vs 18% (Significant Difference).3)Treatment Crossover and Subsequent Therapy: The trial did not allow crossover from the osimertinib group to the combination group, but the proportion of patients receiving subsequent therapy was similar in both groups. In the combination group, 74% received subsequent therapy (chemotherapy 56%, TKI 39%), while in the osimertinib group, 76% received subsequent therapy (chemotherapy 67%, TKI 28%).

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Time to Symptomatic Progression (TTSP)

Controversy Regarding First-Line Treatment of EGFR-Mutant NSCLC:The biggest challenge for Amivantamab is its toxicity. Although the combination group can extend survival by at least 12 months, patients did not cross over to the chemotherapy-Amivantamab group. Therefore, should we "first use Osimertinib and then escalate to the chemotherapy-Amivantamab combination after resistance," or "directly adopt the two-drug combination as first-line treatment"? Should intensified treatment be considered if ctEGFR is not cleared after 4 weeks of Osimertinib treatment?

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Safety

Disclaimer:The information in this article is for general reference only and should not be directly used as decision-making content by doctors, patients, or any entity. "e药安全" (eDrug Safety) assumes no responsibility for any loss incurred by any entity due to the use of the content in this article.

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