Abstract
Introduction:
Although no immunotherapies have yet emerged to fulfill immunologists'
decades-long hope of developing safe, highly effective, tumor-specific
immunotherapies, the field of nonspecific immunomodulatory drugs is enjoying
modest success. Three established immunomodulatory drugs for cancer achieved a
total of $449 million in worldwide sales in 2006. That same year, two
additional agents were launched for the treatment of multiple myeloma. Now,
numerous agents in three classes are in corporate pipelines. These three
classes represent novel approaches to cancer treatment; any additional agents
that prove themselves in the clinic and gain approval would represent a truly
novel class of drugs to be added to oncologists' antitumor drug armamentarium.
Get the Answers You Need to Shape Your Strategy:
- Thalidomide is a notorious drug from the 1960s, when it caused thousands
of birth defects, but Celgene continues to develop several cancer drugs that
are thalidomide derivatives. Which types of cancer is Celgene targeting?
What safety precautions has Celgene taken to ensure the safe use of its
thalidomide derivatives? What evidence is there that thalidomide derivatives
are better at cancer immunomodulation than thalidomide itself?
- Malignant melanoma has long been thought of as a particularly immunogenic
type of cancer, and as such may represent a special opportunity for
immunomodulatory drugs. Which two companies have late-stage
immunomodulatory agents in development to fight melanoma? How significant are
the toxicities associated with these agents?
- Physicians believe that anti-CTLA-4 monoclonal antibodies are the most
exciting biologics in melanoma trials in decades. Why are doctors so
excited about anti-CTLA-4 agents, and which companies are developing
anti-CTLA-4 drugs?
- In 2006, six healthy volunteers in London experienced a severe
inflammatory response within 90 minutes of being administered an experimental
costimulatory T-cell modulating cancer drug. The volunteers became critically
ill with damage to multiple organs. As a result of the debacle, British
regulators instituted new rules for authorizing Phase I trials with
higher-risk compounds. Which drugs do the new regulations especially apply
to?
Scope:
- Historical context: observations of bladder cancer patients; the
tuberculosis vaccine; spontaneous regression of metastatic melanoma.
- Currently marketed immunomodulatory oncology drugs: Novartis' s
Proleukin, Roche' s Roferon-A, and Schering' s Intron-A.
- Thalidomide: new precautions for a notorious drug; approval for
newly diagnosed multiple myeloma; Celgene' s thalidomide derivatives.
- Toll-like receptor agonists: agents currently marketed or being
developed by 3M Pharmaceuticals, Coley Pharmaceuticals/Pfizer, Dynavax
Technologies, Idera Pharmaceuticals, and Mologen.
- Biologics: CTLA-4 antagonists and the CD28 superagonist TGN1412.
- Outlook: Insight into developing safe, effective immunomodulatory
cancer drugs; rising safety concerns; new regulations as a result of
TeGenero' s CD28 trial.
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