Abstract

Active immunotherapy is an interesting field from the industry's perspective and in the last years, regulatory agencies and the medical community have showed renewed expectations and interest in cancer vaccines. The development of new immune therapies offers many challenges, and this is reflected in the small number of phase III trials showing clear benefits. Traditional concepts applied in clinical trials for the development of chemotherapeutic agents may be inadequate for immunotherapies and a new paradigm is emerging. It is possible that organized efforts and funding will accelerate the development of therapeutically effective cancer vaccines. This article reviews the attributes of cancer vaccines which make them attractive from the industry's perspective, and focuses especially in the characteristics of Racotumomab, an anti-idiotype antibody vaccine.

Highlights

  • There are different immunotherapeutic approaches in cancer, including passive and active immunotherapy, adoptive T cell transfer, and non-specific immunotherapy, amongst others

  • Active immunotherapy is an interesting field because vaccines usually have a favorable side effect profile and are well-tolerated and can be used in combination with other therapies

  • The FDA released in October 2011a guidance document for the industry addressing the challenges and particular issues with the development of cancer vaccines such as monitoring for immune response, disease progression/recurrence immediately or shortly after the start of the vaccine, delayed effects of the vaccines when evaluating time to event endpoints, etc (Guidance for Industry, 2011)

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Summary

Introduction

There are different immunotherapeutic approaches in cancer, including passive and active immunotherapy, adoptive T cell transfer, and non-specific immunotherapy, amongst others. Active immunotherapy is an interesting field because vaccines usually have a favorable side effect profile and are well-tolerated and can be used in combination with other therapies. The development of these new immune therapies offers many challenges, and this is reflected in the small number of phase III trials showing clear benefits.

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