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Phase III, randomized, open-label study of durvalumab (MEDI4736) monotherapy, or durvalumab + tremelimumab, versus standard of care (SoC), in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): eagle
© Ferris et al. 2015
Published: 4 November 2015
Patients with R/M SCCHN have a poor prognosis, and current therapies used after failure of first-line platinum-based chemotherapy provide transient, limited benefit. SCCHN tumors are highly immunosuppressive and evade immune detection by exploiting inhibitory immune checkpoints such as the programmed cell death ligand-1 (PD-L1)/programmed cell death-1 (PD-1) axis. High mutational load and their relationship to human papillomavirus (HPV) infection may make these tumors amenable to immunotherapy. Durvalumab is a selective, human IgG1 mAb that blocks binding of PD-L1: to PD-1 (IC50 0.1 nM) and CD80 (IC50 0.04 nM). Tremelimumab is a selective human IgG2 mAb inhibitor of cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). The PD-1 and CTLA-4 pathways are non-redundant and targeting both induces synergistic antitumor effects, according to preclinical data, and was found to be active and tolerable in a Phase Ib study in patients with NSCLC (NCT02000947). Durvalumab monotherapy has also shown preliminary antitumor activity in a Phase I/II study in patients with solid tumors, including a SCCHN cohort (NCT01693562). In a comprehensive clinical development program of durvalumab in SCCHN, the Phase III EAGLE study (NCT02369874) will investigate the efficacy and safety of durvalumab as monotherapy or in combination with tremelimumab versus SoC.
ClinicalTrials.gov identifier NCT02369874.
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