Comparing Patterns of Braf Testing and Treatment in Metastatic Melanoma (Mem) in France, Germany, Italy, Spain and Uk (Eu5) with the Us

Abstract

ABSTRACT Aim: The BRAF V600E mutation is a well established treatment target for a subsection of MeM patients. Yervoy, in all patients, and Zelboraf, in BRAF+ patients, are the leading targeted MeM therapies in the US. However, until recently, only Zelboraf had both 1st and 2nd line approval in Europe. This study describes BRAF testing rates across EU5 and usage of Yervoy and Zelboraf regimens in BRAF+ and BRAF- patients compared to the US Methods: For this study IMS Health Enhanced Tumour Studies™ was used, a patient database collected through quarterly physician panel survey. Only MeM patients currently receiving ATC L01 therapy* were analyzed. Data from July 2010 to Dec 2013 were used for EU5 in addition to full year 2013 data for USA. Results: From a total of 2,629 pts in MAT Q4 2013, 89% (2,344 patients) were identified as being BRAF tested across EU5, compared to only 7% in MAT Q2 2011. Most countries show testing figures above 89% (MAT Q4 2013), excluding Italy where only 69% of patients were tested. In the US 73% (1,678 patients) of a total 2,288 patients were reported as being BRAF tested. The treatment split for Yervoy and Zelboraf is shown below: EU5 EU5 US BRAF + MAT Q2 2011 MAT Q4 2013 MAT Q4 2013 Zelboraf 1st Line 4% (1) 79% (788) 68% (551) 2nd Line 27% (4) 34% (40) 39% (16) Yervoy 1st Line 12% (3) 3% (30) 13% (108) 2nd Line 13% (2) 31% (37) 34% (14) BRAF- Zelboraf 1st Line 1% (7) 1% (12) 3% (41) 2nd Line 0.3% (1) - (0) 3% (2) Yervoy 1st Line 2% (21) 9% (101) 28% (369) 2nd Line 16% (52) 66% (178) 15% (10) Conclusions: Approval of the Cobas 4800 BRAF test (Zelboraf companion test) in Feb 2012 accounts for the large increase in BRAF testing in EU5. With this growth, Zelboraf market share has increased, impacting Yervoy 1st line BRAF+ market share, dropping 9% between MAT Q2 2011 and MAT Q4 2013. There is also a minor increase of 7% for Yervoy in 1st line BRAF- patients between MAT Q2 2011 and MAT Q4 2013 despite only receiving approval for 1st line treatment in Europe in late 2013. This is now expected to increase to come into line with the US BRAF- market. However, more data is required to determine whether similar uptake will be seen in 1st line BRAF+ patients given the availability of Zelboraf and Taflinar. * Antineoplastic agents as per the Anatomical Therapeutic Chemical Classification System. Disclosure: All authors have declared no conflicts of interest.