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Neoadjuvant Immunotherapy

Jay M Lee1

  • 1Thoracic Oncology Program, Jonsson Comprehensive Cancer Center; Division of Thoracic Surgery, David Geffen School of Medicine, UCLA Health, Los Angeles, CA, USA.

Thoracic Surgery Clinics
|November 19, 2025
PubMed

Insights

Immune checkpoint inhibitor (ICI) monotherapy is investigational for early-stage non-small cell lung cancer. Combination chemotherapy and ICI (CT-ICI) demonstrates superior pathologic outcomes, becoming a preferred strategy.

Area of Science:

  • Oncology
  • Immunotherapy
  • Thoracic Surgery

Background:

  • Immune checkpoint inhibitor (ICI) monotherapy is currently investigational for early-stage non-small cell lung cancer (eNSCLC).
  • Neoadjuvant trials identified key early response markers like major pathologic regression and pathologic complete response (pCR).

Purpose of the Study:

  • To evaluate the efficacy and safety of neoadjuvant immune checkpoint inhibitors (ICIs) in eNSCLC.
  • To compare ICI monotherapy with combination chemotherapy and ICI (CT-ICI).

Main Methods:

  • Analysis of Phase 2 neoadjuvant trials for ICI monotherapy and CT-ICI.
  • Evaluation of early response markers including major pathologic regression, pCR, and objective response rate.
  • Consideration of long-term outcomes required for regulatory approval.

Main Results:

  • CT-ICI demonstrated superior pathologic outcomes compared to ICI monotherapy.
  • pCR is a valuable early efficacy marker, but long-term survival data are crucial for FDA approval.
  • ICI monotherapy showed a favorable safety and tolerability profile.
  • Chemotherapy-free dual ICI regimens are still under investigation.

Conclusions:

  • Combination CT-ICI is the preferred neoadjuvant strategy for eNSCLC based on superior pathologic outcomes.
  • While early response markers are informative, definitive FDA approval hinges on long-term event-free or overall survival.
  • Further research is needed for chemotherapy-free dual ICI regimens in eNSCLC.
Keywords:
Early stageImmune checkpoint inhibitionImmunotherapyLung cancerNeoadjuvantNon-small cell lung carcinomaPerioperativeResectable

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