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Soo Park, MD
Soo Park, MD
Posted: Wednesday, July 9, 2025
In a phase II randomized trial (Alliance A091802) reported in the Journal of Clinical Oncology, Dan P. Zandberg, MD, and colleagues compared the survival benefit of adding cetuximab to avelumab vs avelumab alone in patients with advanced cutaneous squamous cell carcinoma (cSCC).
Patients had distant metastatic or unresectable locally advanced cSCC, were anti–PD-1/PD-L1 monoclonal antibody–naive, had received no previous cetuximab in the advanced setting, and had an Eastern Cooperative Oncology Group performance status of 0 to 2. Of the 60 patients enrolled in the trial, 57 were evaluable. All participants were HIV-negative. Patients were randomly assigned between May 2019 and August 2023 to receive avelumab at 800 mg once every 2 weeks for up to 2 years (n = 28) or cetuximab at 500 mg/m2 once every 2 weeks plus avelumab at 800 mg once every 2 weeks for up to 2 years (n = 29). Patients receiving avelumab monotherapy were permitted to cross over to the combination arm at disease progression. The primary endpoint of the trial was progression-free survival.
Participants in the combination therapy group had a median progression-free survival of 11.1 months (95% confidence interval [CI] = 7.6 months to not reached), compared with 3.0 months for those receiving avelumab alone (95% CI = 2.7–13.6 months, hazard ratio = 0.48; P = .018). Avelumab patients who crossed over (n = 9) to the combination arm had a median progression-free survival after crossover of 11.3 months. The confirmed objective response rate was 27.6% with avelumab plus cetuximab and 21.4% with avelumab alone. Grade 3 treatment-related adverse events occurred in 48.3% of patients in the combination arm and 21.5% of those receiving avelumab alone; the most common events in the combination arm were rash and infusion reaction.
The authors concluded that, “Avelumab [plus] cetuximab significantly improved progression-free survival vs avelumab alone in patients with advanced cSCC.”
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
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