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Ivonescimab: First Approval.

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Ivonescimab, a novel bispecific antibody, targets PD-1 and VEGF-A. It received its first approval in China for treating advanced non-small cell lung cancer (NSCLC) after TKI therapy.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Molecular Biology

Background:

  • Non-small cell lung cancer (NSCLC) remains a leading cause of cancer mortality worldwide.
  • Targeting both immune checkpoints (PD-1/PD-L1) and tumor angiogenesis (VEGF-A/VEGFR2) offers a promising therapeutic strategy.
  • Resistance to tyrosine kinase inhibitors (TKIs) necessitates novel treatment approaches for EGFR-mutated NSCLC.

Purpose of the Study:

  • To summarize the development milestones of ivonescimab, a bispecific antibody targeting PD-1 and VEGF-A.
  • To highlight the first regulatory approval of ivonescimab in China for a specific NSCLC patient population.
  • To provide an overview of the mechanism of action and clinical development of ivonescimab.

Main Methods:

  • Development of a first-in-class, humanized, tetravalent bispecific monoclonal antibody (ivonescimab).
  • Preclinical and clinical studies evaluating the dual blockade of PD-1/PD-L1 and VEGF-A/VEGFR2 pathways.
  • Regulatory submission and review process leading to market approval.

Main Results:

  • Ivonescimab simultaneously blocks PD-1/PD-L1 mediated immunosuppression and VEGF-A/VEGFR2 mediated tumor angiogenesis.
  • In May 2024, ivonescimab received its first approval in China.
  • The approval is for patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after TKI therapy, in combination with chemotherapy.

Conclusions:

  • Ivonescimab represents a significant advancement in the treatment of NSCLC, particularly for patients with acquired resistance to TKIs.
  • The dual-targeting mechanism of ivonescimab offers a novel approach to overcome tumor immunosuppression and angiogenesis.
  • Ongoing global clinical trials are expected to further define the role of ivonescimab in various solid tumors.