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Br J Cancer. 2016 Sep 27;115(7):789-96. doi: 10.1038/bjc.2016.271. Epub 2016 Sep 6.

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

Author information

1
Cancer Vaccine Institute, St George's University of London, London, UK.
2
Department of Oncology, Imperial College, Hammersmith Hospital, London, UK.
3
Department of Oncology, Ninewells Hospital, Dundee, UK.
4
Velindre Cancer Centre, Cardiff, UK.
5
Department of Oncology, Azienda Ospedaliera San Gerardo, Monza, Italy.
6
Department of General Surgery, Royal Blackburn Hospital, Blackburn, UK.
7
Department of Oncology, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
8
Médico Adjunto de Oncología Médica, Hospital La Fe de Valencia, Valencia, Spain.
9
Instituto Valenciano de Oncologia, Valencia, Spain.
10
Mount Vernon Cancer Centre, Northwood, UK.
11
Medical Oncology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.
12
Ensayos Clínicos Oncología, Hospital General Universitario de Alicante, Alicante, Spain.
13
Oncology Department, Peterborough and Stamford Hospitals NHS Trust, Peterborough, UK.
14
Medical Oncology, St Vincent's University Hospital and The Adelaide and Meath Hospital, Dublin, Republic of Ireland.
15
Gastrointestinal Cancer Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
16
Department of Medical Oncology, Bank of Cyprus Oncology Centre, Nicosia, Cyprus.
17
Servicio de Oncología Médica, Hospital Miguel Servet, Zaragoza, Spain.
18
Area and Neuroendocrine Tumors Gastrointestinal Medical Oncology, Hospital Central de Asturias, Asturias, Spain.
19
Oncology Department, Fondazione Poliambulanza, Brescia, Italy.
20
TranScrip Partners LLP, Reading, UK.
21
Clinical Oncology, Guy's & St Thomas' Hospitals NHS Trust, London, UK.
22
St George's University of London, Imperial College, London and The Royal Marsden Hospital, London, UK.

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.

PMID:
27599039
PMCID:
PMC5046215
DOI:
10.1038/bjc.2016.271
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Angus G Dalgleish and Andrew Gaya have received travel grants and conference funding from Immodulon Therapeutics. Satvinder Mudan is an unsalaried director and shareholder of Immodulon Therapeutics, Ltd. Robert Glynne-Jones received honoraria and research funding from Merck KgaA, Roche and Sanofi-Aventis. Shama Wagle and Kevin Carroll, of TranScrip, LLP, provided medical writing and statistical support to Immodulon Therapeutics. The remaining authors declare no conflict of interest.

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