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May 8, 2012

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Immunotherapy drugs set to be in the vanguard of cancer fight

MORE than 100 years after researchers first explored the potential to harness the body's immune system to fight cancer, the field's leading doctors see the concept finally proving itself on a large scale in the next year or two.

Two drugs based on immunotherapy are already available and have had mixed results. Bristol-Myers Squibb's Yervoy has been hailed as a major breakthrough for treatment of melanoma since its approval last year, while Dendreon Corp's Provenge prostate cancer vaccine has been hampered by management missteps and doctors' reluctance to adopt the difficult-to-administer therapy after two years on the market.

They are viewed as harbingers of a treatment revolution that could gain a significant share of the global market for oncology drugs, estimated by IMS Health to reach US$75 billion by 2015. Scores of new immunotherapy vaccines and other immune system modifiers are being tested against a variety of cancers.

"We have entered into a new era where immune therapies can be recognized as an important component of cancer treatment," said Dr Glenn Dranoff of the Dana-Farber Cancer Vaccine Center in Boston, Massachusetts.

At least a dozen therapies are set to have key late- or mid-stage trial data over the next 12 months, and some experts believe the results will be a tipping point for the field as clinical successes pile up.

"Several of these are going to (succeed). Once they get approved by the (United States) FDA, they will be used more and more," said Jeffrey Schlom of the National Cancer Institute's Laboratory of Tumor Immunology and Biology.

Among potential new cures are a prostate cancer vaccine from Denmark's Bavarian Nordic, a lung cancer vaccine from GlaxoSmithKline and one for melanoma from Amgen.

The concept of using the immune system against cancer dates back to the 1890s when Dr William Coley, a New York surgeon, noted that some patients who got infections after cancer surgery fared better. He surmised that the immune response triggered by the infection was also working to eradicate cancer.

The new understanding of how immunotherapies work may demand a revised definition of clinical success.

While extending life is the gold standard, most cancer drug trials have been deemed successful if tumors shrink or if a treatment can demonstrate a delay in tumor growth or in worsening of the disease, known as progression-free survival (PFS). But Provenge and Yervoy have extended survival without necessarily impacting PFS or tumor shrinkage in many cases.

"Overall survival is the accurate indicator. Tumors may look bigger because they are filled with immune cells, so they appear worse," said Wolchok. "We've proposed a new set of response criteria to try to incorporate some of this biology."






 

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