Johnson & Johnson's Bispecific Antibody Combination Therapy Approved in China for First-Line Treatment of Non-Small Cell Lung Cancer

August 8, Johnson & Johnson（Johnson & Johnson）Announced that its innovative therapeutic drug, Amivantamab Injection, has officially received approval from the National Medical Products Administration (NMPA) of China, for use in combination with Lazertinib Mesylate Tablets.Carrying epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21L858RFirst-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring substitution mutations. This approval marks the third lung cancer indication for Amivantamab in China this year.

Previously, Amivantamab was approved for use in patients carryingEGFR 20First-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer harboring exon insertions, andEGFRTreatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have classic mutations and disease progression during or after EGFR TKI treatment. This chemotherapy-free regimen can significantly extend overall survival compared to a third-generation EGFR inhibitor, with the median survival not yet reached, and is expected to be extended by more than one year.

Amivantamab is aBispecific Antibody Targeting Both EGFR and MET, which can simultaneously inhibit the EGFR and MET pathways, degrade the EGFR and MET receptors, and also possess immune cell-guiding activity. The synergistic effect of these three mechanisms can effectively suppress and kill tumor cells. Lazertinib is aThird-generation EGFR Tyrosine Kinase Inhibitor (TKI)。Study Confirms That Amivantamab Combined with Lazertinib Can ImproveEGFRThe disease progression of advanced non-small cell lung cancer with mutations, effectively reducing the complexity and heterogeneity of acquired resistance mechanisms.

This approval is based on the results of the Phase 3 MARIPOSA trial, which aims to evaluate amivantamab in combination with lazertinib compared to the control drug as a first-line therapy.EGFREfficacy and Safety in Classic Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. The study results indicate that, compared to the control drug,Amivantamab in combination with Lazertinib reduces the risk of disease progression or death by 30%, with a median progression-free survival (PFS) of 23.7 months, compared to 16.6 months in the control group.

The study also observed that, in the MARIPOSA Asian subgroup population,Control DrugIn comparison, Amivantamab combined with LazertinibCan reduce the risk of disease progression or death by 35%, with a median follow-up of 22.5 months, in the amivantamab plus lenvatinib group andControlThe median PFS for the groups were 27.5 months and 18.3 months, respectively.. In terms of secondary endpoints, compared toCompared with the control group, amivantamab combined with lenvatinib extended the median duration of response (DoR) by 9 months (25.8 months vs 16.8 months).

Final Pre-specified Overall Survival (OS) Analysis Results of the MARIPOSA Study Presented at the 2025 European Lung Cancer Conference (ELCC) Show that Amivantamab in Combination with Lazertinib...EGFR 19Exon deletion or exon 21L858RFirst-line treatment significantly extends overall survival in adult patients with locally advanced or metastatic non-small cell lung cancer harboring substitution mutations.With a median follow-up of 37.8 months, the chemotherapy-free combination of amivantamab and lazertinib demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to the control drug. The median OS for the amivantamab and lazertinib group has not yet been reached, with an estimated extension of median survival exceeding one year.After three and a half years of treatment, 56% of patients in the amivantamab plus lenvatinib group were still alive, compared to only 44% in the control group.

In terms of safety, the safety data of Amivantamab combined with Lazertinib is consistent with previous reports. Most adverse events were grade 1-2 and mainly occurred within the first four months. No new safety signals were identified during long-term follow-up.

Epidemiological data show that patients receiving EGFR TKI treatmentEGFRPatients with mutant advanced non-small cell lung cancer have a 5-year survival rate of less than 20%. The mechanisms of acquired resistance that emerge after previous treatment with third-generation EGFR TKI monotherapy are highly heterogeneous and complex, making post-progression treatment even more challenging. The MARIPOSA study confirmed that, compared to...Third-generation EGFR TKI Monotherapy, the combination of Amivantamab and Lazertinib offers an important new treatment option for these patients with its unique mechanism of action.Not only directly inhibits tumor signaling pathways by blocking ligand binding and receptor degradation, but also exhibits immune cell-directed activity, offering patients more durable clinical benefits.。

References:
[1]Johnson & Johnson announces that RYKETM combined with LKITM has been approved in China for first-line treatment of EGFR classical mutation advanced non-small cell lung cancer. From https://www.prnasia.com/story/499142-1.shtml

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