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

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract

• Effect Size: ORR 20.9% in heavily pretreated population

• Primary Outcome: Objective response rate 20.9% (14/67 patients)

• Nnt Or Sensitivity: Number needed to treat approximately 5 patients for one objective response

• Confidence Interval: 95% CI 11.9-32.6% for ORR

Clinical Application

Requires specialized oncology centers with experience in antibody-drug conjugates and appropriate monitoring capabilities Would require TGA approval and PBS listing consideration. Fits within current COSA guidelines for advanced SCCHN management. May complement existing treatments available through compassionate access programs Australian patients with R/M SCCHN who have progressed after platinum-based chemotherapy and immunotherapy, particularly those with limited treatment options

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).

References

1. 1.Xue, L., Han, Y., Zhang, Q., Li, X., Fang, M., Zhong, L., Wang, S., Liu, Y., Zhang, S., Li, Z., & Guo, Y. (2026). Becotatug Vedotin in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Multicenter, Phase IIa Trial. Clinical Cancer Research, 32(8), 1234-1242. https://doi.org/10.1158/1078-0432.CCR-25-3930