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

Dalgleish, A.G. ; Stebbing, J. ; JA Adamson, D. ; Arif, S.S. ; Bidoli, P. ; Chang, D. ; Cheeseman, S. ; Diaz-Beveridge, R. ; Fernandez-Martos, C. ; Glynne-Jones, R. ; Granetto, C. ; Massuti, B. ; McAdam, K. ; McDermott, R. ; Munoz Martin, A.J. ; Papamichael, D. ; Pazo-Cid, R. ; Vieitez, J.M. ; Zaniboni, A. ; Carroll, K.J. ; Wagle, S. ; Gaya, A. ; Mudan, S.S.

Resumen: 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.

Idioma: Inglés

DOI: 10.1038/bjc.2016.271

Año: 2016

Publicado en: BRITISH JOURNAL OF CANCER 115, 7 (2016), 789-796
ISSN: 0007-0920

Factor impacto JCR: 6.176 (2016)

Categ. JCR: ONCOLOGY rank: 32 / 217 = 0.147 (2016) - Q1 - T1

Factor impacto SCIMAGO: 3.03 - Oncology (Q1) - Cancer Research (Q1)

Tipo y forma: Article (Published version)