WEDNESDAY, June 4, 2025 (HealthDay News) -- For patients with advanced cutaneous squamous cell carcinoma (cSCC), avelumab plus cetuximab significantly improves progression-free survival compared with avelumab alone, according to a study published online May 31 in the Journal of Clinical Oncology to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

Dan P. Zandberg, M.D., from the Hillman Cancer Center at the University of Pittsburgh, and colleagues conducted a randomized phase 2 trial of avelumab plus cetuximab versus avelumab alone once every two weeks for up to two years in patients with advanced cSCC. Sixty patients with distant metastatic or unresectable locally advanced cSCC were enrolled and randomly assigned to avelumab plus cetuximab or avelumab alone; 57 patients were evaluable. Crossover to avelumab + cetuximab was allowed at progression.

The researchers found that progression-free survival improved significantly with avelumab + cetuximab versus avelumab alone (median, 11.1 versus 3.0 months; hazard ratio, 0.48). The nine avelumab patients who crossed over to combination had a median progression-free survival of 11.3 months after crossover. The confirmed objective response rate was 27.6 versus 21.4 percent with avelumab + cetuximab versus avelumab alone. Grade 3 treatment-related adverse events occurred in 48.3 and 21.5 percent of patients with avelumab + cetuximab and avelumab alone, respectively.

"These results show that combining immune checkpoint inhibition targeting the PD-1: PD-L1 pathway with avelumab plus EGFR-targeted IgG1 monoclonal antibody cetuximab can provide meaningful clinical benefit compared to avelumab alone for patients with advanced cSCC," Zandberg said in a statement. "It opens the door to future research and new strategies for improving outcomes in this difficult disease."

Several authors disclosed ties to the biopharmaceutical industry.

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