An Open-Label Phase II Study to Evaluate the Efficacy and Safety Of PDR001 in Patients with Advanced Well-Differentiated Non-Functional NET of Pancreatic, Gastrointestinal (GI), or Thoracic Origin Who Have Progressed on Prior Treatment Abstract #1797

Introduction: Monoclonal antibody (mAb) inhibitors of immune checkpoints, including anti-PD-1 and anti-PD-L1, have become established treatment (tx) options in various solid tumors. However, there is a paucity of data on checkpoint inhibitors in NET. In a phase I trial of PDR001 (mAb checkpoint inhibitor targeting PD-1) conducted in patients (pts) with multiple solid tumor types, a pt with histologically confirmed metastatic atypical pulmonary carcinoid demonstrated a RECIST-based tumor response and clinical benefit.
Aim(s): This study will evaluate the antitumor activity, safety, and tolerability of single-agent PDR001 in pts with progressive, non-functional NET.
Materials and methods: Pts with non-functional unresectable advanced well-differentiated grade 1/2 NET of GI, pancreatic or thoracic origin who progressed on or after prior available tx will be included. Overall response rate is the primary outcome and duration of response and safety are the key secondary outcomes, respectively.
Conference: 14th Annual ENETS conference (2017)
Category: Medical treatment - Targeted therapies
Presenting Author: James C Yao
Keywords: PDR001, immunotherapy, NET

To read results and conclusion, please login ...

Further abstracts you may be interested in

#1437 Efficacy and Safety of Everolimus in Advanced, Progressive, Nonfunctional Neuroendocrine Tumors (NET) of the Lung: A Subgroup Analysis of the Phase 3 RADIANT-4 Study
Introduction: In the phase 3, RADIANT-4 study, everolimus (EVE) improved median progression-free survival (PFS) by 7.1 months in patients (pts) with advanced, progressive, nonfunctional NET of lung or GI tract compared to placebo (PBO); HR, 0.48; 95%CI, 0.35-0.67; P<0.00001.
Conference: 13th Annual ENETS conference (2016)
Category: Non digestive NETs (bronchial, MTC, pheochromocytoma)
Presenting Author: Dr. Nicola Fazio
#1495 Everolimus for Advanced, Progressive, Nonfunctional Neuroendocrine Tumors (NET) of the Gastrointestinal (GI) Tract: Efficacy and Safety from a RADIANT-4 Subgroup Analysis
Introduction: Everolimus (EVE) demonstrated progression-free survival (PFS) benefit of 7.1 months compared to placebo in the phase 3 RADIANT-4 study in patients (pts) with advanced, well-differentiated, progressive, nonfunctional NET.
Conference: 13th Annual ENETS conference (2016)
Category: Medical treatment - Targeted therapies
Presenting Author: Simron Singh
#1502 Impact of Prior Chemotherapy (Chemo) on Progression-free Survival (PFS) in Patients (Pts) with Advanced, Nonfunctional Lung or Gastrointestinal (GI) Neuroendocrine Tumors (NET): A Secondary Analysis from the Phase 3 RADIANT-4 Study.
Introduction: In the phase 3 RADIANT-4 study, everolimus (EVE) improved PFS by 7.1 months (mo) compared to placebo (PBO; P<0.00001) in pts with advanced, progressive, nonfunctional NET of lung or GI tract.
Conference: 13th Annual ENETS conference (2016)
Category: Medical treatment - Targeted therapies
Presenting Author: Dr. Rodney Pommier
#1503 Impact of Prior Somatostatin Analogue (SSA) Use on Progression-free Survival (PFS) in Patients with Advanced Nonfunctional Neuroendocrine Tumors (NET) of Lung or Gastrointestinal (GI) Origin: A Secondary Analysis from the RADIANT-4 Study
Introduction: In the RADIANT-4 study, everolimus (EVE) reduced the risk of disease progression or death by 52% vs placebo (PBO; P<0.00001) in patients (pts) with advanced, well-differentiated, progressive, nonfunctional NET of lung/GI tract.
Conference: 13th Annual ENETS conference (2016)
Category: Medical treatment - Targeted therapies
Presenting Author: Roberto Buzzoni
#2071 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
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.
Conference: 15th Annual ENETS conference (2018)
Category: Medical treatment -Targeted therapies
Presenting Author: Anamika Gulati
Authors: Yao J C, Fazio N, Li D, Pavel M, ...
Keywords: PDR001, immunotherapy, NET