Abstract
Although recent FDA approvals on ipilimumab and sipuleucel-T represent major milestones, the ultimate success of immunotherapy approaches will likely benefit from appropriate combinations with other immunotherapeutic and/or non-immunotherapeutic approaches. However, implementation of ideal combinations in the clinic may still face formidable challenges in regulatory, drug-availability and intellectual property aspects. The 2011 SITC annual meeting hosted a workshop on combination immunotherapy to discuss: 1) the most promising combinations found in the laboratory; 2) early success of combination immunotherapy in clinical trials; 3) industry perspectives on combination approaches, and 4) relevant regulatory issues. The integrated theme was how to accelerate the implementation of efficacious combined immunotherapies for cancer patients. Rodent animal models are providing many examples of synergistic combinations that typically include more than two agents. However, mouse and human immunology differ in a significant number of mechanisms and hence we might be missing opportunities peculiar to humans. Nonetheless, incisive animal experimentation with deep mechanistic insight remains the best compass that we can use to guide our paths in combinatorial immunotherapy. Combination immunotherapy clinical trials are already in progress and preliminary results are extremely promising. As a key to translate promising combinations into clinic, real and “perceived” business and regulatory hurdles were debated. A formidable step forward would be to be able to test combinations of investigational agents prior to individual approval. Taking together the FDA and the industrial perspective on combinatorial immunotherapy, the audience was left with the clear message that this is by no means an impossible task. The general perception is that the road ahead of us is full of combination clinical trials which hopefully will bring clinical benefit to our cancer patients at a fast pace.
Highlights
Recent FDA approvals on ipilimumab and sipuleucel-T represent major milestones, the ultimate success of immunotherapy approaches will likely benefit from appropriate combinations with other immunotherapeutic and/or non-immunotherapeutic approaches
Exciting results have been recently reported with immunostimulatory monoclonal antibodies [3,4,5,6], with cancer vaccines [7] and with adoptive T cell therapies [8,9]
The following four themes were selected for the focus of a workshop at the 2011 SITC meeting devoted to immunotherapy using combinatorial treatment approaches: (i) How to best identify at an early stage of development the most efficacious combinations; (ii) How to recognize problems of safety early in development; (iii) How to approach combinatorial treatments from a regulatory point of view; and (iv) How to deal with legitimate interests of intellectual/industrial property, commercialization and risk-taking in the life-cycle of innovative drugs
Summary
Recent FDA approvals on ipilimumab and sipuleucel-T represent major milestones, the ultimate success of immunotherapy approaches will likely benefit from appropriate combinations with other immunotherapeutic and/or non-immunotherapeutic approaches. The need for immunotherapy combinations The long quest to attain clinical benefit in cancer patients by activating the immune system against such a deadly disease is paying off [1,2]. Exciting results have been recently reported with immunostimulatory monoclonal antibodies (mAbs) [3,4,5,6], with cancer vaccines [7] and with adoptive T cell therapies [8,9].
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