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Title: Immunotherapy of Ipilimumab and Nivolumab in patients with advanced neuroendocrine tumours: a subgroup analysis of the CA209-538 clinical trial for rare cancers.
Austin Authors: Klein, Oliver ;Kee, Damien ;Markman, Ben;Michael, Michael;Underhill, Craig R;Carlino, Matteo S;Jackett, Louise A ;Lum, Caroline;Scott, Clare L;Nagrial, Adnan;Behren, Andreas;So, Jane Yeojeong;Palmer, Jodie;Cebon, Jonathan S 
Affiliation: Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
Medical Oncology, Blacktown Hospital; University of Sydney
Department of Medical Oncology, Austin Health, Heidelberg, Victoria, Australia
Oncology, Border Medical Oncology
Oncology, Monash Medical Centre..
Medical Oncology, Peter MacCallum Cancer Centre..
Medicine, Melanoma Institute Australia, The University of Sydney, Blacktown Hospital, and Crown Princess Mary Cancer Centre, Westmead Hospital..
Department of Anatomical Pathology, Austin Health, Heidelberg, Victoria, Australia
Oncology, Monash Medical Centre..
Cancer Biology and Stem Cells Division Division, Walter and Eliza Hall Institute of Medical Research..
Medical Oncology, Monash Medical Centre..
Issue Date: 12-Jun-2020 2020
Publication information: Clinical Cancer Research 2020; online first: 12 June
Abstract: Combination immunotherapy with anti-CTLA-4 and anti-PD-1 blockade has demonstrated significant clinical activity across several tumour types. Neuroendocrine tumors (NETs) are a heterogeneous group of rare tumors with limited treatment options. CA209-538 is a clinical trial of combination immunotherapy with ipilimumab and nivolumab in rare cancers, including advanced NETs. CA209-538 is a prospective multicentre clinical trial in patients with advanced rare cancers. Patients received treatment with nivolumab at a dose of 3mg/kg and ipilimumab at 1mg/kg every three weeks for four doses, followed by nivolumab 3mg/kg every two weeks and continued for up to 96 weeks, until disease progression or the development of unacceptable toxicity. Response was assessed every 12 weeks by RECIST 1.1. The primary endpoint was clinical benefit rate. Twenty-nine patients with advanced NETs received treatment. Three patients (10%) had low, 13 (45%) intermediate and 13 (45%) high grade tumors; lung was the most common primary site (39%). The objective response rate was 24% with a CBR of 72%; 43% of patients with pancreatic neuroendocrine neoplasms (NENs) and 33% of patients with atypical bronchial carcinoid achieved an objective response. The median progression free survival was 4.8 months (95% CI: 2.7, 10.5) and overall survival 14.8 months (95% CI: 4.1,21.3). Immune-related toxicity was reported in 66% of patients with 34% experiencing grade 3/4 events. Combination immunotherapy with ipilimumab and nivolumab demonstrated significant clinical activity in subgroups of patients with advanced NETs including patients with atypical bronchial carcinoid and high grade pancreatic NENs.
DOI: 10.1158/1078-0432.CCR-20-0621
ORCID: 0000-0002-4685-1666
PubMed URL: 32532787
ISSN: 1078-0432
Type: Journal Article
Appears in Collections:Journal articles

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