Johnson & Johnson Submits New Drug Applications in China for EGFR/MET Bispecific Antibody Amivantamab and Third-Generation EGFR-TKI Lazertinib

Jan 26, 2024 11:21 CST Updated 11:21

Johnson & Johnson

Medical Device R&D and Manufacturer

▎Edited by the WuXi AppTec content team

Today (January 26), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Johnson & Johnson's Two Product Marketing Applications Accepted, RespectivelyEGFR/MET Bispecific Antibody TherapyAmivantamab Injection (amivantamab)AndThe Third Generation of EGFR-TKI Oral DrugsLangetinib Mesylate Tablets (lazertinib）。

Screenshot source:CDE Official Website

Amivantamab is under Johnson & Johnson.Johnson & Johnson Innovative MedicineAn investigational fully human bispecific antibody targeting EGFR and MET,In addition to blocking EGFR and MET-mediated signal transduction, it can also direct immune cells to target those with activating and resistant mutations.EGFR/METTumors with Mutations and Amplifications。In May 2021, the product received formal approval from the U.S. FDA.，Used for the treatment during or after progression of platinum-based chemotherapyEGFRExon20Insertion mutation non-small cell lung cancer (NSCLC) patients. In August 2023, the product was also submitted to the FDA.Submitted a Supplemental Biologics License Application (sBLA), Used in combination with chemotherapy as a first-line treatment for patients carryingEGFRExon20Patients with locally advanced or metastatic NSCLC with insertional mutations.

In China, Amivantamab was included by the CDEBreakthrough Therapy Drug, for the treatment of progression during or after platinum-based doublet chemotherapy, or intolerance to platinum-based chemotherapyEGFR 20Patients with metastatic or surgically unresectable NSCLC harboring exon insertions. In October 2023, the product's marketing application was accepted by the CDE.Acceptance. This is the second marketing application for the product submitted in China.

According to the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, Johnson & Johnson has registered and launched an international multicenter Phase 3 clinical study in China, aiming toFailure of Osimertinib TreatmentEGFRLocally Advanced or Metastatic NSCLC with MutationsPatientComparison of Evermon in ChinaSafety and Efficacy of Monoclonal Antibody, Lanzetinib, and Platinum-based Chemotherapy Combination Treatment Compared with Platinum-based ChemotherapyThese patientsCarryEGFR 19Exon Deletion（ex19del）Or21Extra ExonL858RSubstitution Mutation。

Public information shows that Johnson & Johnson has successively submitted listing applications to the U.S. FDA, seeking approval respectively.AmivantamabCombination chemotherapy (carboplatin and pemetrexed) for patients with locally advanced or metastatic NSCLC whose tumors carryex19delOrL858RSubstitution mutations, and disease progression occurring during or after treatment with osimertinib; andAmivantamab in combination with LazertinibFirst-line Treatmentex19delOrL858RSubstitution MutationAdult patients with locally advanced or metastatic NSCLC.

According to an earlier press release from Johnson & Johnson, the MARIPOSA-2 Phase 3 clinical study has already been explored.AmivantamabCombination chemotherapy (carboplatin and pemetrexed), with or without oral administration of third-generation EGFR-TKILanreotideWhen used to treat locally advanced or metastaticEGFREfficacy and Safety in Patients with Mutant NSCLC.The analysis shows,Compared with chemotherapy alone,Amivantamab+ ChemotherapyReduced the risk of disease progression or death by 52%;Amivantamab+ Chemotherapy CombinationLanreotideReduced the risk of disease progression or death by 56% compared to chemotherapy alone.Amivantamab+ The ORR of patients in the chemotherapy group was 64%.Amivantamab+ The ORR for patients treated with chemotherapy and lazertinib was 63%, compared to 36% in the chemotherapy-alone group.

Results from the MARIPOSA Phase 3 clinical study show,AmivantamabUnitedLanreotideCompared with the active control TKI drug osimertinib,InAs a first-line therapyTreatment withEGFR ex19del orL858RPatients with locally advanced or metastatic NSCLC with mutationsCan reduce the risk of disease progression or death by 30% in patients.。During the median follow-up period of 22 months，AmivantamabUnitedLanreotideTheThe median progression-free survival (PFS) was 23.7 months, compared to 16.6 months for the active comparator.

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References：

[1] Website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Retrieved Jan 25, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC). Retrieved December 21, 2023 from https://www.jnj.com/johnson-johnson-submits-supplemental-biologics-license-application-and-new-drug-application-to-u-s-fda-seeking-approval-of-rybrevant-amivantamab-vmjw-plus-lazertinib-for-the-treatment-of-patients-with-egfr-mutated-non-small-cell-lung-cancer-nsclc

[3] Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer Who Progressed on or after Osimertinib. Retrieved November 20, 2023 from https://www.jnj.com/janssen-submits-supplemental-biologics-license-application-to-u-s-fda-seeking-approval-of-rybrevant-amivantamab-vmjw-plus-chemotherapy-for-the-treatment-of-patients-with-egfr-mutated-non-small-cell-lung-cancer-who-progressed-on-or-after-osimertinib

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