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Clinical evaluation of therapeutic cancer vaccines
- Source :
- Human Vaccines & Immunotherapeutics. 9:1049-1057
- Publication Year :
- 2013
- Publisher :
- Informa UK Limited, 2013.
-
Abstract
- Therapeutic cancer vaccines are an immunotherapy that targets tumor antigens to induce an active immune response. To date, Provenge® is the only therapeutic cancer vaccine approved by the United States Food and Drug Administration. Although therapeutic cancer vaccines have not been approved by the European Medicines Agency (EMA), they have been approved in several countries other than the United States (US) and the European Union (EU). Provenge® is the only approved cancer vaccine that showed significant primary endpoint efficacy in a phase III study at the time of approval. Retrospective analysis of 23 completed or terminated phase III studies showed that 74% (17/23) failed to demonstrate significant efficacy in the primary endpoint. The reasons for failure were surveyed in 13 of the 17 studies. Despite efforts to minimize tumor burden, including surgery and induction chemotherapy before therapeutic cancer vaccine therapy, 69% (9/13) of the phase III studies failed. These findings indicate that tumor burden may not be the only prognostic factor. Immunological response has often been used as a predictive factor, and a small number of sub-group analyses have succeeded in showing that immunological response is associated with the efficacy of therapeutic cancer vaccines. Being a prognostic factor, inclusion of immunological response in addition to tumor stage in the eligibility criteria or sub-group analysis may minimize study population heterogeneity, a key factor in the success of phase III studies.
- Subjects :
- Oncology
medicine.medical_specialty
medicine.medical_treatment
Immunology
Cancer Vaccines
Neoplasms
Internal medicine
medicine
Clinical endpoint
Humans
Immunology and Allergy
media_common.cataloged_instance
European union
Drug Approval
media_common
Pharmacology
Clinical Trials as Topic
business.industry
Induction chemotherapy
Cancer
Immunotherapy
medicine.disease
Clinical trial
Treatment Outcome
Population study
Cancer vaccine
business
Research Paper
Subjects
Details
- ISSN :
- 2164554X and 21645515
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- Human Vaccines & Immunotherapeutics
- Accession number :
- edsair.doi.dedup.....de4c3c6466fd8b30cf466277215f2c2b