Cancer immunotherapy, which marshals a patient's immune system to attack malignant cells, has long been modeled and assessed by the same criteria used for chemotherapy despite distinct differences between these 2 treatment methods.

But in a recent letter (Nat Biotechnol 2011;29:867–70), the Cancer Immunotherapy Consortium of the Cancer Research Institute and the Association for Cancer Immunotherapy outline a methodologic framework to recognize these differences and ultimately to speed such treatments.

As the letter describes, immunotherapy differs from chemotherapy in 5 key ways:

In addition to improving immunotherapy study design, the proposed framework seeks standardized criteria to measure immune response and develop biomarkers, as well as a more formal network to monitor trial results. The authors call on regulatory authorities to guide this new paradigm.

Approvals of 2 immune-based drugs in recent years have bolstered this emerging field. The first, the therapeutic vaccine sipuleucel-T (Provenge; Dendreon), treats hormone-refractory prostate...

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