CDSCO Panel grants J&J Protocol Amendment proposal to study anticancer drug Amivantamab and Lazertinib

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin, and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data.

This came after the drug major Johnson and Johnson presented protocol amendment 6.0 dated 22 December 2022 protocol No. 61186372NSC3002.

Lazertinib is an orally available third-generation, selective inhibitor of certain forms of the epidermal growth factor receptor (EGFR) with activating mutations, including the resistance mutation T790M, exon 19 deletions (Del19), and the L858R mutation, with potential antineoplastic activity. Upon administration, lazertinib specifically and irreversibly binds to and inhibits selective EGFR mutants, which prevents EGFR mutant-mediated signaling and leads to cell death in EGFR mutant-expressing tumor cells. Lazertinib may inhibit programmed cell death-1 ligand 1 (PD-L1) and inflammatory cytokines in specific cancer cells harboring certain EGFR mutations.

Amivantamab is an EGF and MET receptor-targeted antibody indicated in the treatment of non-small cell lung cancer with an EGFR 20 exon insertion mutation.

Amivantamab targets both EGFR and MET, preventing ligands from binding to the receptors, blocking signaling, marking the cancerous cells for antibody-dependant cellular cytotoxicity by natural killer cells, and allowing macrophages to perform trogocytosis.

At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the protocol amendment 6.0 dated 22 December 2022 protocol No. 61186372NSC3002 presented by the drug major Johnson & Johnson.

After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.

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