Dissemin is shutting down on January 1st, 2025

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Springer Nature [academic journals on nature.com], British Journal of Cancer, 9(115), p. e16-e16, 2016

DOI: 10.1038/bjc.2016.342

Springer Nature [academic journals on nature.com], British Journal of Cancer, 7(115), p. 789-796, 2016

DOI: 10.1038/bjc.2016.271

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

Journal article published in 2016 by Angus G. Dalgleish, Justin Stebbing, Douglas Ja A. Adamson, Seema Safia Arif, Paolo Bidoli, David Chang, Sue Cheeseman, Robert Diaz-Beveridge, Carlos Fernandez-Martos, Rob Glynne-Jones, Cristina Granetto, Bartomeu Massuti ORCID, Karen McAdam, Raymond McDermott ORCID, Andrés J. Muñoz Martín and other authors.
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

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.