Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study.

•OS was not significantly different for durvalumab or for durvalumab plus tremelimumab compared with SoC.•The study was not designed to assess OS between immunotherapies, but adding tremelimumab did not appear to enhance durvalumab activity.•Failure to meet the primary end point may have been impacted by factors resulting in an unexpectedly long OS for the SoC arm.