The investigators at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting here in Chicago earlier this summer were enthusiastic about new immune therapy drugs that unleash the powers of the immune system on cancer. One experimental therapy gaining the most attention is Bristol-Myers Squibb's skin cancer treatment, ipilimumab. In recent trials, ipilimumab has been effective in keeping terminal melanoma patients alive for nearly a year longer than existing treatments.
Ipilimumab is an antibody that blocks CTLA-4. It was discovered about 10 years ago by Dr. James Allison, then at the University of California, Berkeley, and now head of the immunology department at Sloan-Kettering. Allison found that the antibody had the remarkable ability to completely knock out tumors in mice. In initial human clinical trials, the drug was almost quashed after patients were getting sicker and tumors kept growing. Scientists soon discovered, however, that these were actually signs that the drug was doing its job, rather than making patients sicker.
Scientists are also exploring possible uses for ipilimumab in the treatment of tumors of the lung and prostate. If testing continues to be successful, ipilimumab and other immune therapy drugs have the potential to evolve into more than just one-target treatments. Next-generation immunotherapy drugs have the potential to train the immune system to attack cancer cells, similarly to the way a virus is killed.
If all goes according to plan, ipilimumab will be available to physicians and patients in 2012, and analysts are predicting that ipilimumab could reach $1 billion in annual sales within its first 5 years on the market.
While it's still too early to claim that we've found a cure for cancer, researchers are optimistic that ipilimumab has the potential to change cancer from a terminal disease to a chronic, yet manageable condition.
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Thurs 8/18
Bristol-Myers Squibb today announced that the U.S. FDA has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company also announced today that the application has been granted a priority review designation by the FDA.
Ipilimumab is Bristol-Myers Squibb's second drug under priority review by the FDA this year. A priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on FDA's six month goal for completing priority reviews, the projected FDA action date is December 25, 2010.
The filing is based on results from the primary analysis of the pivotal MDX010-020 trial, which were published online in the New England Journal of Medicine and presented during a plenary session at the 46th Annual Meeting of the American Society of Clinical Oncology in June 2010. The study compared the overall survival rate of patients who received ipilimumab plus the gp100 vaccine (3 mg/kg and 1mg/kg every three weeks for four doses; n=403), ipilimumab alone (3 mg/kg every three weeks for four doses; n=137) and the control therapy of gp100 alone (n=136).
Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities for the treatment of adult patients with previously treated advanced melanoma.
About Ipilimumab
Ipilimumab is a novel T-cell potentiator that specifically blocks the inhibitory signal of CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. Suppression of CTLA-4 can augment the immune system's T-cell response. Ipilimumab is an investigational compound and is not currently approved for use by health authorities.
About Metastatic Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. As with many cancers, it is more difficult to treat once the disease has spread beyond the skin to other parts of the body by way of the bloodstream or the lymphatic system (metastatic disease).
The incidence of melanoma has increased ten-fold over the past 50 years, and has steadily increased since the 1970s. The American Cancer Society (ACS) estimates that there were approximately 68,000 new cases of melanoma in the U.S. in 2009. Melanoma accounts for about three percent of skin cancer cases, but it causes most skin cancer deaths. The ACS estimates that, in 2009, there were approximately 8,700 deaths from melanoma in the U.S.
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