Amivantamab Receives NMPA Approval in China for New Indication in EGFR-Mutated NSCLC

May 19, 2025 00:01 CST Updated 00:01

Johnson & Johnson

Medical Device R&D and Manufacturer

EGFR Lung Cancer Patient Communication Group(Click)

Recently (April 25), Johnson & Johnson announced that a new indication for Amivantamab Injection has been approved.Approved by the National Medical Products Administration (NMPA) of China.Amivantamab (amivantamab) is aEGFR/MET Bispecific Antibody Therapy,This approval is for use inIn combination with carboplatin and pemetrexed for the treatment of patients withEpidermal Growth Factor Receptor（EGFR）19del or L858R mutation and disease progression during or after EGFR-TKI treatmentLocally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer（NSCLC）Adult patients.Previously approved for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations.

May 2021(Click)，U.S. FDAApproval of Amivantamab for the treatment of advanced NSCLC patients with EGFR 20ins whose disease has progressed after failure of platinum-based chemotherapy.March 2024, Amivantamab receivedFully approved by the U.S. FDA, in combination with chemotherapy for first-line treatment of locally advanced or metastaticEGFRExon20Insertion MutationPatients with NSCLC.August 2024，The U.S. FDA approved amivantamab + lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR 19del or L858R mutations.Median OS Improved by More Than One Year。

Amivantamab (trade name: Rybrevant) is a product under Johnson & Johnson.Johnson & Johnson Innovative MedicineDevelopedA bispecific antibody under research that targets EGFR and MET. In addition to blocking EGFR and MET-mediated signal transduction, it can also guide immune cells to target activating and resistantEGFR/METTumors with Mutations and Amplifications。

This approval is mainly based onMARIPOSA-2 Study Results.

MARIPOSA-2 Study:It is a randomized, open-label Phase III study aimed at evaluating the efficacy and safety of amivantamab + chemotherapy ± lazertinib versus chemotherapy in patients with locally advanced or metastatic NSCLC harboring common EGFR mutations after osimertinib resistance. The dual primary endpoints are PFS for Amivantamab + chemotherapy vs chemotherapy and Amivantamab + Lazertinib + chemotherapy vs chemotherapy.

Research Results:With a median follow-up of 8.7 months, the ami-chemo group and ami-laz-chemo group significantly reduced the risk of disease progression or death by 52% and 56%, respectively, compared to the chemo group (P<0.001).The median PFS for the ami-chemo group vs ami-laz-chemo group vs chemo group was 6.3 months vs 8.3 months vs 4.2 months, with ORRs of 64% vs 63% vs 36%, respectively (P<0.001).。

In terms of intracranial PFS, the ami-chemo group and ami-laz-chemo group significantly reduced the risk of intracranial disease progression or death by 45% (P=0.001) and 42% (P<0.001), respectively. The median intracranial PFS for the ami-chemo group vs ami-laz-chemo group vs chemo group was 12.5 months vs 12.8 months vs 8.3 months, with 1-year intracranial PFS rates of 50% vs 54% vs 34%, respectively.

The median OS is not yet mature, with a trend towards benefit in both the ami-chemo group and the ami-laz-chemo group compared to the chemo group. The OS HRs were 0.77 (95% CI: 0.49-1.21) and 0.96 (95% CI: 0.67-1.35), respectively.。In terms of safety,The main AEs in the Amivantamab group were hematologic toxicity, EGFR and MET-related adverse events.

Adverse Reactions

Summary:In EGFR-mutated advanced NSCLC patients who progressed after osimertinib treatment, the Amivantamab + chemotherapy group and the Amivantamab + Lazertinib + chemotherapy group showed improvements in PFS, ORR, and intracranial PFS compared to the chemotherapy group, which may represent a new standard of care.

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