Durvalumab with or without tremelimumab for patients with metastatic pancreatic ductal adenocarcinoma: A phase 2 randomized clinical trial
JAMA Oncology Jul 24, 2019
O’Reilly EM, et al. - In this multicenter, 2-part, phase 2 randomized clinical trial, researchers assessed anti–programmed death-ligand 1 antibody using either durvalumab monotherapy or in combination with the anticytotoxic T-lymphocyte antigen 4 antibody using durvalumab plus tremelimumab therapy in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC, n=65), focusing on safety and efficacy. In part A of this trial, good tolerability of durvalumab plus tremelimumab therapy was evident in patients with mPDAC. This treatment resulted in an objective response rate of 3.1%; no patients responded to durvalumab monotherapy. A population of patients with poor prognoses and rapidly progressing disease was reflected by the efficacy of immunotherapy in part A of this trial. For either arm (durvalumab plus tremelimumab therapy or durvalumab monotherapy), an objective response rate of 10% was needed for continuation to part B, therefore, part B was not performed based on the results of part A.
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