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

Dalgleish, A; Stebbing, J; Adamson, D; Arif, S; Bidoli, P; Chang, D; Cheeseman, S; Diaz-Beveridge, R; Fernandos-Martos, C; Glynne-Jones, R; et al. Dalgleish, A; Stebbing, J; Adamson, D; Arif, S; Bidoli, P; Chang, D; Cheeseman, S; Diaz-Beveridge, R; Fernandos-Martos, C; Glynne-Jones, R; Granetto, C; Massuti, B; McAdam, K; McDermott, R; Munoz Martin, AJ; Papamichael, D; Pazo-Cid, R; Vieitez, J; Zaniboni, A; Carroll, K; Wagle, S; Mudan, S; Gaya, A (2016) Randomised, open-label, phase II study of Gemcitabine with and without IMM-101 for advanced pancreatic cancer. British Journal of Cancer, 115 (7). pp. 789-796. ISSN 1532-1827 10.1038/bjc.2016.271
SGUL Authors: Dalgleish, Angus George

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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)+GEM (1000 mg m−2 intravenously; n=75), or GEM alone (n=35). Safety was assessed on frequency and incidence of adverse events (AEs). Overall survival (OS), progression-free 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-101+GEM v 5.6 months for GEM; while not significant, the hazard ratio (HR) numerically favoured IMM-101+GEM (HR, 0.68 (95% CI, 0.44–1.04, P=0.074). In a pre-defined metastatic subgroup (84%), OS was significantly improved from 4.4 to 7.0 months in favour of IMM-101+GEM (HR, 0.54, 95% CI 0.33–0.87, P=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.

Item Type: Article
Additional Information: 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/ A corrigendum associated with this article is available from https://dx.doi.org/10.1038/2Fbjc.2016.342
Keywords: Oncology & Carcinogenesis, 1112 Oncology And Carcinogenesis
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: British Journal of Cancer
ISSN: 1532-1827
Dates:
DateEvent
22 July 2016Accepted
6 September 2016Published Online
27 September 2016Published
Publisher License: Creative Commons: Attribution 4.0
URI: http://openaccess.sgul.ac.uk/id/eprint/108152
Publisher's version: 10.1038/bjc.2016.271

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