MVA-MUC1-IL2 vaccine immunotherapy (TG4010) improves PSA doubling time in patients with prostate cancer with biochemical failure

Invest New Drugs. 2009 Aug;27(4):379-86. doi: 10.1007/s10637-008-9187-3. Epub 2008 Oct 18.


Purpose: TG4010 is a recombinant MVA vector expressing the tumor-associated antigen MUC1 and IL2. We explored the effect two schedules of TG4010 on PSA in men with PSA progression.

Patients and methods: A randomized phase II trial was conducted in 40 patients with PSA progression. Patients had PSA doubling times less than 10 months, with no overt evidence of disease. Patients received either weekly subcutaneous injection (sc) of TG4010 10(8) pfu for 6 weeks, then one injection every 3 weeks or sc injection of TG4010 10(8) pfu every 3 weeks.

Results: The primary endpoint of a 50% decrease in PSA values from baseline was not observed. Nevertheless, 13 of 40 patients had a more than two fold improvement in PSA doubling time. Ten patients had their PSA stabilized for over 8 months. Therapy was well tolerated.

Conclusions: Although the primary endpoint was not achieved, there is evidence of biologic activity of TG4010 in patients with PSA progression, further investigation in prostate cancer is warranted.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Cancer Vaccines / administration & dosage
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / therapeutic use*
  • Disease Progression
  • Drug Administration Schedule
  • Humans
  • Immunotherapy / methods
  • Injections, Subcutaneous
  • Interleukin-2 / immunology
  • Male
  • Membrane Glycoproteins / administration & dosage
  • Membrane Glycoproteins / adverse effects
  • Membrane Glycoproteins / therapeutic use*
  • Middle Aged
  • Mucin-1 / immunology
  • Prostate-Specific Antigen / blood
  • Prostate-Specific Antigen / drug effects*
  • Prostatic Neoplasms / drug therapy*
  • Prostatic Neoplasms / immunology
  • Time Factors
  • Treatment Outcome


  • Cancer Vaccines
  • Interleukin-2
  • MUC1 protein, human
  • Membrane Glycoproteins
  • Mucin-1
  • TG4010
  • Prostate-Specific Antigen