Becotatug Vedotin in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Multicenter, Phase IIa Trial

  • Clin Cancer Res. 2026 Apr 15;32(8):1445-1453. doi: 10.1158/1078-0432.CCR-25-3930.
Liqiong Xue  #  1 ,  Yaqian Han  #  2 ,  Qingyuan Zhang  3 ,  Xia Li  4 ,  Meiyu Fang  5 ,  Laiping Zhong  6 ,  Siyang Wang  7 ,  Yanyan Liu  8 ,  Songnan Zhang  9 ,  Zhiming Li  10 ,  Ye Guo  1
Affiliations
  • 1. Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
  • 2. Department of Radiotherapy, Hunan Cancer Hospital, Changsha, China.
  • 3. Breast Internal Medicine, Harbin Medical University Cancer Hospital, Harbin, China.
  • 4. Department of Radiotherapy and Chemotherapy, Liaoning Cancer Hospital & Institute, Shenyang, China.
  • 5. Department of Head and Neck and Rare Tumor, Zhejiang Cancer Hospital, Hangzhou, China.
  • 6. Department of Oral and Maxillofacial - Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai, China.
  • 7. Department of Head and Neck Oncology, The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai, China.
  • 8. Department of Lympho-Mammary Comprehensive, Henan Cancer Hospital, Zhengzhou, China.
  • 9. Department of Oncology, Yanbian University Hospital, Yanji, China.
  • 10. Department of Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
  • # Contributed equally.
PMID: 41603720 DOI: 10.1158/1078-0432.CCR-25-3930
Abstract

Purpose: This multicenter, phase IIa trial (NCT04868162) investigated the efficacy and safety of becotatug vedotin, an anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have limited therapeutic options.

Patients and methods: Patients with R/M SCCHN who progressed after platinum-based chemotherapy and/or programmed cell death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors, including those with multiple lines of prior therapy, were administered intravenous becotatug vedotin at either 2 or 2.3 mg/kg every 3 weeks. The primary endpoint was the objective response rate (ORR).

Results: Sixty-seven patients were enrolled (35 received 2 mg/kg and 32 received 2.3 mg/kg). The ORR was 20.9% [14/67, 95% confidence interval (CI), 11.9-32.6], with a median duration of response (DoR) of 10.9 months (95% CI, 2.6-15.1). The median progression-free survival (PFS) was 2.9 months (95% CI, 1.8-3.9), and the median overall survival (OS) was 6.7 months (95% CI, 5-8.9). Treatment-related adverse events (TRAE) were reported in 91% (61/67) patients, most commonly being rash (26.9%), pruritus (25.4%), constipation (23.9%), and anemia (20.9%).

Conclusions: Becotatug vedotin demonstrated promising antitumor activity with a manageable safety profile in previously heavily treated R/M SCCHN, particularly at the recommended dose of 2.3 mg/kg, among patients who had failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors (≤2 prior lines of therapy).

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