Last summer we reported that an experimental drug called Yervoy or ipilimumab showed promise in extending the survival rates for patients with advanced melanoma. This drug was recently approved by the FDA in March of this year and is being combined with chemotherapy to treat patients with metastatic melanoma. Yervoy works by boosting the patient’s immune system to fight off cancer. Yervoy was developed by Bristol Myers Squibb in its US laboratory and is reported to prolong the life of patients suffering from advanced melanoma by 34 percent. In early June of this year researchers presented findings from studies on Yervoy as well as a new experimental drug called vemurafenib during the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. We are going to give you some of the highlights of this new research and what it means for you.
The Studies on Yervoy and Vemurafenib
The primary conclusion of the studies on both Yervoy and vemurafenib as published online in the New England Journal of Medicine is that these two drugs can improve the survival of patients who have advanced melanoma.
The following are links to the original research on these two skin cancer drugs:
What is vemurafenib and how does it work?
Vemurafenib is an experimental drug manufactured by Hoffmann-La Roche which targets gene mutations responsible for the development of some types of melanoma tumors. It is estimated that approximately half of all melanomas may be caused by a gene mutation called BRAF. This gene mutation produces an enzyme which increases the odds for melanin-producing cells or melanocytes to develop cancer. Vemurafenib is an antibody which binds to BRAF and prevents it from producing tumors.
How effective is vemurafenib for treating advanced melanoma?
The results of the study published in the June issue of The New England Journal of Medicine show so much promise that the study was ended early so that all study participants could begin taking this drug instead of the traditional melanoma treatment, dacarbazine.
Here are some other highlights from this study:
• After three months, patients who took vemurafenib were 63% less likely to die than those study participants who took only dacarbazine, a chemotherapy drug.
• Vemurafenib was also associated with a reduction of 74% in the risk of either death or disease progression as compared to dacarbazine.
• At six months the survival rate for the study participants who were given vemurafenib was 84% compared to only 64% of those who were only taking the chemotherapy drug dacarbazine.
Is vemurafenib appropriate for all melanoma patients?
In a recent NPR interview, Dr. George Sledge, the current President of The American Society of Clinical Oncology explains that only about 45 to 50% of melanoma patients have the BRAF gene mutation. The patients who do not have this mutation will not respond to this drug. This drug is also targeted for those who have advanced cases of metastatic melanoma.
What are the risks or limitations of using vemurafenib?
• Right now this drug is not yet FDA approved or available for all patients. Research is still being conducted to show long term efficacy for vemurafenib.
• The latest study reported that 38% of patients required dose modification because of toxic effects. These effects included rash, fatigue, hair-loss, nausea, diarrhea and the increased development of non-melanoma skin cancers.
• The cost may be high for patients. The manufacturer of vemurafenib has not set a price yet on their drug as it is not yet FDA approved. As reported by Bloomberg the other melanoma drug of promise, Yervoy, will cost $30,000 a dose or $120,000 for a four-dose course of treatment.
• Long term studies have not yet been conducted so we don’t know how long this drug can extend the survival rate for someone with this type of gene related melanoma.
What is next on the horizon for melanoma drug research?
The latest news reports indicate that researchers are interested in developing a “drug cocktail” to treat melanoma much like they do for AIDs patients. Instead of comparing the efficacy of Yurvoy with Venurafenib, they wish to see if they can combine these drugs somehow to increase their overall effectiveness in treating advanced melanoma. Time and more research are necessary to test such a hypothesis and a willingness of competitors to merge their interests to develop such a cocktail. It will be interesting to see what scientific developments come from this initial research on these individual drugs. It appears that science is on the verge of a major breakthrough when it comes to treating even the most advanced types of melanoma.
For more information about melanoma prevention and treatment please refer to Skin Cancer Connection’s Skin Cancer Resource Guide.
Published On: June 27, 2011