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

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Dalgleish, AG
  • Stebbing, J
  • Adamson, DJA
  • Arif, SS
  • Bidoli, P
  • Chang, D
  • Cheeseman, S
  • Fernandez-Martos, C
  • Glynne-Jones, R
  • Granetto, C
  • Massuti, B
  • McAdam, K
  • McDermott, R
  • Martin, AJM
  • Papamichael, D
  • Pazo-Cid, R
  • Vieitez, JM
  • Zaniboni, A
  • Carroll, KJ
  • Wagle, S
  • Gaya, A
  • Mudan, SS

Grupos

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(-1) 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.

Datos de la publicación

ISSN/ISSNe:
0007-0920, 1532-1827

BRITISH JOURNAL OF CANCER  SPRINGERNATURE

Tipo:
Article
Páginas:
789-796
PubMed:
27599039
Factor de Impacto:
3,030 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 43

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Keywords

  • pancreatic cancer; Mycobacterium obuense; phase II; advanced pancreatic ductal adenocarcinoma; immunotherapy; gemcitabine; IMM-101; immunomodulator

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