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May the 4th has become known as a day when Star Wars fans unite (May the Fourth be with you) however, this year, May the 4th was also designated by The American Academy of Dermatology as “Melanoma Monday”1 and kicked off a month-long campaign to raise awareness of the dangers of Skin Cancer. Melanoma is the most serious type of skin cancer, typically caused by ultraviolet radiation from sunlight or tanning beds. According to the American Cancer Society, ‘an estimated 73,870 new cases of melanoma will be diagnosed in 2015.’2

 

Despite widespread public service messages regarding the dangers of UV exposure and the myriad of products designed to decrease the risk, the American Cancer Society reports that an estimated 9,940 people will die from melanoma in 2015, an increase of 230 deaths from the 9,710 deaths projected in the 2014 Cancer Facts & Figures Report.3

 

To see what has changed in the treatment landscape of Melanoma in US clinical trials a comparison was conducted between completed/ terminated industry-sponsored trials over the past 10 years versus current studies found in Citeline’s Trialtrove.

 

Completed and terminated Industry-sponsored Melanoma trials over the past 10 years show the following top 5 drugs:

Melanoma-Monday-Chart-1

Source Citeline’s Trialtrove® (accessed on 4/23/15)

 

Alternately, the Top 5 Primary drugs studied in ongoing/planned industry-sponsored Melanoma trials

 Melanoma-Monday-Chart-2

 

 

 

Source Citeline’s Trialtrove® (accessed on 4/23/15)

 

While Bristol-Myers Squibb’s ipilimumab resides in the top spot in both of the examples above, we see that nivolumab has taken over as the second most common primary drug studied in ongoing and planned clinical trials as opposed to the previous #2 drug, GlaxoSmithKline’s dabrafenib.

 

 

What ipilimumab (Yervoy) and Nivolumab (Opdivo) have in common besides being manufactured by Bristol-Myers Squibb is that they are both part of a group of drugs labeled checkpoint inhibitors which are gaining momentum as combined therapies in the fight against Melanoma and other cancers. One recent example showing great promise of combining these drugs is the CheckMate 069 study, a Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma. Results for CheckMate 069 were presented at the 106th AACR Annual Meeting, April 18-22, 2015, in Philadelphia where investigators shared that Nivolumab (NIVO) + Ipilimumab (IPI) significantly improved objective response rate (ORR) and progression-free survival (PFS), compared to IPI alone in treatment-naïve patients with advanced melanoma, and had a manageable safety profile.4

 

While results like this are certainly encouraging and exciting to hear, let’s take a step back and focus on the true message of Melanoma Monday and Skin Cancer Awareness Month which is prevention and encouraging early detection. If looking to find clinical trial investigators, the place to be is Texas with 131 investigators followed by California (114), then Pennsylvania (104), New York (73) and Massachusetts (55) being the top 5 locations as shown on Sitetrove’s map of US Melanoma Investigators in ongoing Industry studies.

 

Melanoma-Monday-Chart-3

 

 Source: Citeline’s Sitetrove® (accessed on 5/4/15)

 

 

Finally, there are a number of tools available to help with a self-exam or in locating a free skin cancer screening location near you such as this tool provided by the American Academy of Dermatology https://www.aad.org/scs/search/default.aspx?state=.

 

 

Sunny days are here again, but don’t forget those sunny days bring exposure to harmful UV rays. Get out there and enjoy the outdoors just don’t forget the sunblock!

 


References:

  1. American Academy of Dermatology. Melanoma Monday https://www.aad.org/spot-skin-cancer Citations/community-programs-events/melanoma-monday Accessed April 10, 2015
  2. American Cancer Society. Cancer Facts & Figures 2015. http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf. Accessed April 10, 2015
  3. American Cancer Society. Cancer Facts & Figures 2014 http://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf. Accessed April 10, 2015
  4. F. Stephen Hodi, Michael A. Postow, Jason Chesney, Anna C. Pavlick, Caroline Robert, Kenneth Grossmann, David McDermott, Gerald Linette, Nicolas Meyer, Jeffrey Giguere, Sanjiv S. Agarwala, Montaser Shahee2, Marc S. Ernstoff, David R. Minor, April Salama, Matthew H. Taylor, Linda Rollin, Christine Horak, Paul Gagnier, Jedd D. Wolchok. Improved clinical response in patients with advanced melanoma treated with nivolumab combined with ipilimumab compared to ipilimumab alone [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; 2015. Abstract nr 2860 http://www.abstractsonline.com/plan/ViewAbstract.aspx?mID=3682&sKey=72104ef5-2237-46d6-a1a5-403333deb391&cKey=b376f0e9-1d9f-49d3-8660-c956d7b640f6&mKey=19573a54-ae8f-4e00-9c23-bd6d62268424

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