Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer
Por:
Dalgleish, A, Stebbing, J, Adamson, D, Arif, 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, Papamichael, D, Pazo-Cid, R, Vieitez, J, Zaniboni, A, Carroll, K, Wagle, S, Gaya, A and Mudan, S
Publicada:
1 sep 2016
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(-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.
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