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Sex-based differences in tolerability of developmental antibody-drug conjugates (ADCs) in non-small-cell lung cancer

C Parisi1, M Banini2, F Mantuano3

  • 1Department of Medical Oncology, International Centre for Thoracic Cancers (CICT), Gustave Roussy, Villejuif, France; Faculty of Medicine, University of Paris-Saclay, Kremlin-Bicêtre, France; Department of Medical and Surgical Sciences and Translational Medicine, St Andrea University Hospital, Sapienza University, Rome, Italy.

ESMO Open
|June 22, 2026
PubMed
Abstract

Insights

Women treated with antibody-drug conjugates for non-small-cell lung cancer experienced more adverse events. These findings highlight the need to consider sex in monitoring strategies for these novel anticancer therapies.

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Translational Medicine

Background:

  • Sex-based differences in anticancer therapy adverse events are documented.
  • Limited sex-disaggregated safety data exists for antibody-drug conjugates (ADCs) in non-small-cell lung cancer (NSCLC).

Purpose of the Study:

  • To investigate sex-based differences in treatment-related adverse events (TRAEs) for developmental ADCs in advanced NSCLC patients.
  • To analyze safety profiles of ADCs by sex in a clinical trial setting.

Main Methods:

  • Monocentric cohort study of advanced NSCLC patients treated with developmental ADCs (Phase I-II trials, 2018-2023).
  • Analysis of clinically significant TRAEs (Grade ≥2), dose modifications, hospitalizations, and survival outcomes stratified by sex.
  • Utilized univariate and multivariate statistical analyses.

Main Results:

  • 132 patients included: 64 women (48.5%) and 68 men (51.5%).
  • Women exhibited a higher incidence of Grade ≥2 TRAEs (82.8% vs. 69.1%) and a greater median number of TRAEs (2 vs. 1).
  • Metabolic TRAEs and dose reductions were significantly more frequent in women.

Conclusions:

  • Women treated with developmental ADCs for advanced NSCLC face a higher burden of clinically relevant TRAEs.
  • Sex is a critical factor for safety reporting and monitoring strategies in developmental ADCs for NSCLC.
Keywords:
ADCsAEsNSCLCadverse eventsantibody-drug conjugatesclinical trialsgendernon-small-cell lung cancersex

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