[HTML][HTML] Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer
AG Dalgleish, J Stebbing, DJA Adamson, SS Arif… - British journal of …, 2016 - nature.com
AG Dalgleish, J Stebbing, DJA Adamson, SS Arif, P Bidoli, D Chang, S Cheeseman…
British journal of cancer, 2016•nature.comBackground: 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) …
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) …
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.
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