ElevatION:NET-201 A Phase II Study to Evaluate the Efficacy and Safety of PDR001 in Patients with Metastatic, Well-Differentiated NET of Pancreatic/GI/Thoracic Origin or Poorly-Differentiated GEP NEC Who Have Progressed on Prior Treatment

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Introduction: Monoclonal antibody (mAb) inhibitors of immune checkpoints, including anti–PD-1 and anti–PD-L1, have become established treatment options in various solid tumors. However, there is a paucity of data on treatment effect of checkpoint inhibition in neuroendocrine tumors (NET) and neuroendocrine carcinoma (NEC). PDR001 is a high-affinity, humanized IgG4 mAb directed against PD-1 that blocks the binding of PD-L1 and PD-L2 to PD-1.

Aim(s): This study will evaluate the antitumor activity, safety, and tolerability of single-agent PDR001 in patients with progressive, nonfunctional well-differentiated NET and poorly-differentiated GEP NEC.

Materials and methods: Patients with nonfunctional advanced well-differentiated grade 1/2 NET of GI, pancreatic or thoracic origin and poorly-differentiated GEP NEC who have progressed on or after prior available treatment were included. Overall response rate (by RECIST 1.1.and Blinded Independent Review Committee) is the primary objective and duration of response in each group is the key secondary objective.

Conference: 15th Annual ENETSConcerence (2018)

Presenting Author:

Authors: Yao J, Fazio N, Li D, Pavel M, Strosberg J,

Keywords: PDR001, immunotherapy, NET,