This morning health business mavens are chirping with bright results for ipilimumab, a monoclonal antibody that can extend life in people with metastatic melanoma. If the new data – which I haven’t seen – are true, it’s good news for patients.
In 2010, melanoma affected 68,000 people in the U.S. and led to death in approximately 8,700. The WHO estimates that over 50,000 people die of this disease worldwide annually. For patients with metastatic disease, median survival is less than one year.
Last August, investigators reported in the NEJM that ipilimumab prolonged overall survival in patients with metastatic melanoma from approximately 6 to 10 months. Those findings were based on a randomized, multicenter Phase III study funded by Bristol-Myers Squibb, the drug’s manufacturer. In that trial, the most common serious toxicity of the drug was deemed to be immune-based diarrhea. Now, the drug is up for FDA approval and Bristol-Myers is saying that another study (“024” – presumably that’s short for CA184-024) reveals prolonged survival in patients with advanced melanoma. The findings will be presented at the ASCO meeting in early June.
Ipilimumab binds a molecule called CTLA-4 (cytotoxic T-lymphocyte-associated antigen-4) on the surface of T cells. It works as a double negative kind of immune activator: by blocking CTLA-4, which normally clamps down on lymphocyte activity, the drug fosters an anti-melanoma response by the body’s healthy immune cells. Like other monoclonal antibodies, Ipilimumab is given to patients by intravenous infusion. So it’s costly in itself, and because of the need for nurses to administer the drug, IV equipment, etc.
In principle, this drug might be applied to other tumors or infectious diseases to which the immune system doesn’t adequately respond. The NIH Clinical Trials website lists other protocols, including other tumor types, for which this drug is being tried.