Yesterday, The New York Times posted an article about new drugs useful in the treatment of malignant skin cancer. The drugs, vemurafenib and ipilimumab, produced dramatic results in the treatment of skin tumors.
What The Studies Show
Vermurafenib is produced by Genentech and Plexxikon Inc. It inhibits cell growth by targeting the V600E mutation in the BRAF gene, which has been found in about half of all skin cancer tumors. In clinical trials, vermurafenib has been found to cause a 74% reduction in progression of the disease and a 63% reduction in the risk of death.
In the case of the second drug, the Bristol-Myers Squibb Co.-produced monoclonal antibody ipilimumab (AKA Yervoy), 47.3% of patients who received the ipilimumab and dacarabazine (standard treatment) were still alive after one year, compared with 36.3% of those receiving only dacarbazine. At three years, survival was 21.0% with the combination of drugs, versus 12.0% for chemotherapy alone. Both studies are available from The New England Journal of Medicine.
4 Reasons You Shouldn’t Get Too Excited…Yet
Unfortunately, this is not an invitation for you to go to the beach sunscreen-free. As Tim Turnham, director of the Melanoma Research Foundation told the LA Times today, “This is not the breakthrough that we really need for this population,” he says. “There’s been a lot of hype in the news, but this is not a home run. It’s a really solid single.” Turnham could not be more correct. Here are four reasons why:
1. Cost
In today’s economy, patients are unemployed or uninsured at alarming rate. This is a problem for cancer patients, as there is a dramatic decline in cancer treatment during times of high unemployment, as 34 years of research from St. Luke’s-Roosevelt and Beth Israel Medical Center radiation oncologist Dr. Ronald Ennis has demonstrated. Ennis found that every 1 percent increase in unemployment was associated with a 7.4 percent decrease in diagnoses [i.e., physician visits], a 16.8 percent decrease in radiation treatment and a 23.9 percent decrease in surgery for cancer patients.
Unfortunately, this does not bode well for metastatic skin cancer patients. One estimate shows that vermurafenib may cost as much as $50,000 per patient, while ipilimumab taps out at an impressive $120,000. If physician visits are down in this economy, how can we expect patients to afford the new higher-technology drugs?
2. Life-Prolonging, But Not Life-Saving, Treatments
Despite the shiny headlines across the media today, it is important to understand that neither vermurafenib nor ipilimumab will cure metastatic melanoma. Rather, it has only been found that these drugs may prolong the lifespan of a patient with the disease. Currently, patients with the diagnosis typically live 6 to 10 months. Patients undergoing the treatment may expect a few extra years of life. But it’s not expected to be a cure.
3. Not All Patients Will Respond
The third problem is that only part of the affected population will respond to the drug. As first reported by the LA Times today, the studies suggest only one out of four patients with malignant melanoma will respond to the drugs. Given that 9000 people worldwide will die each year from the condition, the estimated number of lives saved – 2250 – is still significant. (Heck, one life saved is significant!) But it is important to note that these are not treatments that will be effective for all metastatic melanoma patients.
4. These Drugs Have Not Been Shown to Work Together Yet
Lastly, while Roche and Bristol-Myers said on June 1-2 they would conduct tests combining vemurafenib and ipilimumab, these studies will likely take some time, and it is unknown if these drugs will work together synergistically or not.
Bottom Line: Exciting Developments, But They Need Time
We live in exciting times for medicine and biotechnology, and with skin cancer on the rise, I certainly understand the excitement behind these two new drugs. While I point out reasons patients should not go out and bask in the sun right now, falsely believing these treatments make them foolproof, I also think these drugs will revolutionize the way skin cancer is treated long into the future. As Dr. Antoni Ribas of the University of California tells The New York Times, “You don’t need to wait for 50 percent of 675 patients to die to conclude that the one [new] drug is much better than the other.” These drugs work. Hopefully we will be able to extend the technology to prolong lifespan further, find biomarkers to identify and target which patients respond to treatment, and reduce costs in the future. In the meantime, do yourself a favor and wear some broad-spectrum sunscreen and a wide-brimmed hat!
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