Racotumomab-alum vaccine for the treatment of non-small-cell lung cancer

Expert Rev Vaccines. 2015 Jan;14(1):9-20. doi: 10.1586/14760584.2015.984691. Epub 2014 Nov 25.


Racotumomab-alum vaccine is an anti-idiotypic vaccine able to mimic the tumor-associated antigen NeuGcGM3. Different Phase I clinical trials and compassionate use studies demonstrated its low toxicity and capacity to induce a strong anti-NeuGcGM3 response, able to bind and directly kill tumor cells expressing the antigen. A Phase II/III randomized double-blind clinical trial in advanced non-small cell lung cancer patients showed a significant improvement in overall survival and progression-free survival for racotumomab-alum versus placebo. Patients who developed anti-NeuGcGM3 antibodies capable of binding and killing NeuGcGM3 expressing tumor cells showed significantly longer median survival times. The impact of using racotumomab-alum as switch maintenance followed by second-line therapy is currently being explored in a new randomized, multinational Phase III study.

Keywords: NSCLC; NeuGcGM3; anti-idiotypic antibody; clinical trial; vaccine.

Publication types

  • Review

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Adjuvants, Immunologic / adverse effects
  • Alum Compounds / administration & dosage*
  • Alum Compounds / adverse effects
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / immunology
  • Antibodies, Monoclonal, Murine-Derived
  • Cancer Vaccines / administration & dosage
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / immunology*
  • Carcinoma, Non-Small-Cell Lung / therapy*
  • G(M3) Ganglioside / analogs & derivatives
  • G(M3) Ganglioside / antagonists & inhibitors
  • G(M3) Ganglioside / immunology
  • Humans
  • Randomized Controlled Trials as Topic
  • Survival Analysis
  • Treatment Outcome


  • Adjuvants, Immunologic
  • Alum Compounds
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Murine-Derived
  • Cancer Vaccines
  • G(M3) Ganglioside
  • aluminum sulfate
  • racotumomab
  • N-glycolylneuraminyllactosylceramide