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Robert L. Ferris, MD, PhD, director of University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, Hillman Professor of Oncology, associate vice chancellor for cancer research, professor of otolaryngology, immunology, and radiation oncology, co-director, Tumor Microenvironment Center, UPMC Hillman Cancer Center, discusses a clinical trial testing ADU-S100/MIW815 plus pembrolizumab (Keytruda) in patients with head and neck cancer.

The phase III JAVELIN Head and Neck 100 trial has been terminated after an interim analysis showed that the addition of avelumab to standard-of-care chemoradiotherapy was unlikely to lead to a statistically significant improvement in progression-free survival in patients with untreated locally advanced squamous cell carcinoma of the head and neck.

The United Kingdom’s National Institute for Health and Care Excellence has issued guidelines recommending against pembrolizumab for use in treatment-naïve patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score of ≥1.

The European Commission has approved pembrolizumab as a monotherapy or in combination with platinum and 5-FU chemotherapy for the frontline treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression (composite positive score ≥1) on their tumors.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab as a monotherapy or in combination with platinum and 5-FU as frontline treatment for patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression on their tumors.