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Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

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Title: Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer
Authors: Dalgleish, AG
Stebbing, J
Adamson, DJA
Arif, SS
Bidoli, P
Chang, D
Cheeseman, S
Diaz-Beveridge, R
Fernandez-Martos, C
Glynne-Jones, R
Granetto, C
Massuti, B
McAdam, K
McDermott, R
Munoz Martin, AJ
Papamichael, D
Pazo-Cid, R
Vieitez, JM
Zaniboni, A
Carroll, KJ
Wagle, S
Gaya, A
Mudan, SS
Item Type: Journal Article
Abstract: Background: Immune Modulation and Gemcitabine Evaluation-1, a randomised, open-label, phase II, first-line, proof of concept study (NCT01303172), explored safety and tolerability of IMM-101 (heat-killed Mycobacterium obuense; NCTC 13365) with gemcitabine (GEM) in advanced pancreatic ductal adenocarcinoma. Methods: Patients were randomised (2 : 1) to IMM-101 (10 mg ml l intradermally) þ GEM (1000 mg m 2 intravenously; n ¼ 75), or GEM alone (n ¼ 35). Safety was assessed on frequency and incidence of adverse events (AEs). Overall survival (OS), progressionfree survival (PFS) and overall response rate (ORR) were collected. Results: IMM-101 was well tolerated with a similar rate of AE and serious adverse event reporting in both groups after allowance for exposure. Median OS in the intent-to-treat population was 6.7 months for IMM-101þ GEM v 5.6 months for GEM; while not significant, the hazard ratio (HR) numerically favoured IMM-101þ GEM (HR, 0.68 (95% CI, 0.44–1.04, P¼ 0.074). In a pre-defined metastatic subgroup (84%), OS was significantly improved from 4.4 to 7.0 months in favour of IMM-101þ GEM (HR, 0.54, 95% CI 0.33–0.87, P¼ 0.01). Conclusions: IMM-101 with GEM was as safe and well tolerated as GEM alone, and there was a suggestion of a beneficial effect on survival in patients with metastatic disease. This warrants further evaluation in an adequately powered confirmatory study.
Issue Date: 6-Sep-2016
Date of Acceptance: 22-Jul-2016
URI: http://hdl.handle.net/10044/1/48908
DOI: https://dx.doi.org/10.1038/bjc.2016.271
ISSN: 0007-0920
Publisher: Cancer Research UK
Start Page: 789
End Page: 796
Journal / Book Title: British Journal of Cancer
Volume: 115
Issue: 7
Copyright Statement: © 2016 Cancer Research UK. All rights reserved 0007 – 0920/16. This work is licensed under the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Sponsor/Funder: Action Against Cancer
Funder's Grant Number: 092015-02
Keywords: Science & Technology
Life Sciences & Biomedicine
pancreatic cancer
Mycobacterium obuense
phase II
advanced pancreatic ductal adenocarcinoma
Aged, 80 and over
Antimetabolites, Antineoplastic
Biomarkers, Tumor
Cancer Vaccines
Carcinoma, Pancreatic Ductal
Combined Modality Therapy
Disease-Free Survival
Immunotherapy, Active
Kaplan-Meier Estimate
Middle Aged
Neoplasm Metastasis
Pancreatic Neoplasms
Treatment Outcome
Oncology & Carcinogenesis
1112 Oncology And Carcinogenesis
Publication Status: Published
Appears in Collections:Department of Surgery and Cancer