Efficacy and safety of disitamab vedotin in treatment of advanced gastric cancer based on real-world - Report - MDSpire

Efficacy and safety of disitamab vedotin in treatment of advanced gastric cancer based on real-world

  • By

  • Pan Cheng

  • Jianjuan Ge

  • Shuangjia Huang

  • Dongzan Yang

  • Shining Xie

  • Bowen Wang

  • Zhaoshi Bai

  • Jichen He

  • Xiaolin Liu

  • May 20, 2026

  • 0 min

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Clinical Report: Real-World Assessment of Disitamab Vedotin's Efficacy and Safety

Overview

Disitamab vedotin (RC48) demonstrates a 10.3% objective response rate and a manageable safety profile in patients with HER2-expressing advanced gastric cancer. The disease control rate was notably higher in patients receiving RC48 as third-line therapy.

Background

Gastric cancer is a prevalent malignancy with significant morbidity and mortality, particularly in regions like China. HER2-targeted therapies have emerged as crucial treatment options for HER2-positive gastric cancer, yet existing therapies like trastuzumab have limitations. Disitamab vedotin represents a novel antibody-drug conjugate aimed at improving outcomes in this challenging patient population.

Data Highlights

ParameterValue
Objective Response Rate (ORR)10.3%
Disease Control Rate (DCR)63.8%
Median Progression-Free Survival (mPFS)4.2 months
1-Year Progression-Free Survival Rate13.0%
Grade III or Higher Adverse Drug Reactions (ADRs)17.2%

Key Findings

  • The objective response rate (ORR) for disitamab vedotin was 10.3%.
  • The disease control rate (DCR) was 63.8%, with higher rates in third-line therapy (75.0%) compared to later lines (50.0%).
  • Median progression-free survival (mPFS) was 4.2 months, with male patients showing longer mPFS than female patients (4.9 vs. 2.6 months).
  • Common adverse drug reactions included neutropenia, hemoglobin reduction, and liver impairment.
  • 17.2% of patients experienced grade III or higher adverse drug reactions.

Clinical Implications

The findings suggest that disitamab vedotin may be a viable option for patients with HER2-expressing advanced gastric cancer, particularly in the third-line setting. Clinicians should be aware of the manageable safety profile and monitor for common adverse events during treatment.

Conclusion

Disitamab vedotin shows potential efficacy and a manageable safety profile in real-world settings for advanced gastric cancer, warranting further exploration in clinical practice.

Related Resources & Content

  1. Sheng et al., ASCO Post, 2023 -- Disitamab Vedotin in Previously Treated Patients With Advanced HER2-Positive Urothelial Carcinoma
  2. Frontiers in Oncology, 2026 -- Efficacy analysis of disitamab vedotin (RC-48) in the treatment of HER2-low metastatic breast cancer: a case report
  3. Sheng et al., ASCO Post, 2025 -- Disitamab Vedotin Plus Toripalimab vs Chemotherapy in HER2-Expressing Advanced Urothelial Cancer
  4. Frontiers in Immunology, 2026 -- Disitamab vedotin (RC48) combined with PD-1 inhibitors in locally advanced or metastatic urothelial carcinoma: clinical outcomes and prognostic factors from a multicenter real-world study
  5. FDA, 2025 -- FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
  6. The Chinese Society of Clinical Oncology (CSCO), 2023 -- Clinical guidelines for the diagnosis and treatment of gastric cancer
  7. Study Details | NCT06221748 | DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy
  8. FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1) | FDA
  9. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2023 | Cancer Communications

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