Melanoma 2016 — the Year in Review
By Louise M. Perkins, Ph.D., MRA Chief Science Officer | 20 January 2017 | News
In the nearly 10 years since MRA’s founding in 2007, there has been extraordinary progress for melanoma. With 11 new treatments approved since 2011 it began to feel like frequent new drug approvals was the current norm. For this to be the case would have been both amazing and truly unprecedented. Instead, what we saw in 2016 was a more typical pace of a) learning how to use the drugs we have better – whether for melanoma or other cancers; and, b) working on prevention of melanoma.
What became clear in 2016 was that other cancers are benefiting from the lessons learned in melanoma, especially cancers treatable with immunotherapy. This includes lung cancer, bladder cancer, classical Hodgkin lymphoma as well as head and neck cancer. Additionally, the data are very encouraging for patients with a skin cancer called Merkel cell carcinoma and a colon cancer subtype known as MSI-H.
While excellent work with promising results was reported at scientific meetings, 2016 was a year in which melanoma research advances were not underscored by drug approvals. Indeed, the 2016 MRA Scientific Retreat Report entitled, The Next Frontier in Melanoma Research, called attention to two pertinent facts. There is an urgent need for more research leading to improved use of the treatments already in the melanoma armamentarium and also for testing of new treatments for those melanoma patients not benefiting from existing options. Moreover, preventing more melanomas from forming and diagnosing the disease earlier is another important area.
So, with all of that said, what was the major progress in the fight against melanoma in 2016?
A snapshot of clinical trials for advanced disease shows us the following:
Several Phase 3 studies concluded or were started in 2016 – this is frequently the last step of testing and if the results are positive will lead to a new treatment being approved. MRA adivser, Jeffrey Weber, summarized some of the work that is focusing on combination treatment approaches here. Among those starting Phase 3 were:
Array BioPharma’s binimetinib in NRAS mutant melanoma alone and in combination with the new BRAF inhibitor, encorafenib has encouraging results. Array has submitted their data to the FDA for regulatory approval of binimetinib in melanoma and a decision is expected no later than June 30, 2017.
Genentech announced plans to start a Phase 3 study of its BRAF/MEK inhibitor combination (vemurafenib/cobimetinib) with its anti-PD-L1 immunotherapeutic, atezolizumab. This move is based on encouraging early clinical data that was presented in 3Q16.
Incyte and Merck launched a Phase 3 study of the combination of Incyte’s new IDO1 drug, epacadostat, in combination with Merck’s anti-PD-1 antibody, pembrolizumab.
Bristol-Myers Squibb undertook several Phase 3 programs, an example of which can be found here, to explore/optimize the dose of its anti-PD-1 antibody, nivolumab, in combination with its anti-CTLA-4 antibody, iplimumab.
A word on side effects of immunotherapy:
There has been some fairly visible coverage of immunotherapy side effects in the press and one patient I talked to found those stories to be discouraging as he considers his melanoma immunotherapy treatment. That’s unfortunate. Some of these side effects are clearly of great concern and if you are being treated, follow your doctor’s advice on them. Still, for most people with melanoma, these life-saving drugs are very well tolerated.
What about prevention and early diagnosis?
2016 saw the release of the U.S. Preventive Services Task Force Recommendation (USPSTF) on screening for melanoma in the general population by general practitioners as discussed in a separate July 29, 2016 blog here. The USPSTF published a recommendation stating that there is not sufficient evidence to weigh the benefits of visual skin cancer screening by primary care providers (PCPs) against potential harms for symptom-free individuals who are not at increased risk for melanoma. To be clear, that’s not the same thing as saying skin screening isn’t valuable. It’s just that there isn’t enough evidence to recommend it by general practitioners in the general population.
In addition, a paper published in the Journal of the American Academy of Dermatology made the case for a total tanning bed ban that would save over 6,000 lives and prevent nearly 62,000 melanoma cases from being diagnosed. Over $340 million in treatment costs would be saved via this measure.
All in all, 2016 was another year of continued progress in the melanoma fight and we are excited to continue to be working on all fronts to further the fight against this devastating disease.