Analysis of marketed melanoma drugs – development history, key clinical trial data, and assessment of clinical and commercial attractiveness Analysis of marketed and pipeline drugs in comparison to current standard of care In-depth analysis of late-stage pipeline drugs – development overview, SWOT analysis, and assessment of clinical and commercial attractiveness Discussion and assessment of pipeline drugs’ ability to meet unmet needs in treatment of melanoma

1. Product Profiles: Melanoma - Novel combination therapies will increase
competition for marketed drugs
The melanoma market has seen an increase in developer attention following recent breakthroughs.
The identification of the role of BRAF mutations has revolutionized the treatment of melanoma, but
with drug resistance a problem there is an opportunity for developers to move into this market.
Novel combination therapies and immunotherapies are now poised to compete with the current
marketed drugs.
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Features and benefits
Analysis of marketed melanoma drugs – development history, key clinical trial data, and
assessment of clinical and commercial attractiveness
Analysis of marketed and pipeline drugs in comparison to current standard of care
In-depth analysis of late-stage pipeline drugs – development overview, SWOT analysis, and
assessment of clinical and commercial attractiveness
Discussion and assessment of pipeline drugs’ ability to meet unmet needs in treatment of
melanoma
Highlights
Yervoy and Zelboraf’s high costs have generated significant commercial reward, but have limited
uptake of the drugs in more cost-conservative markets. However, where funded they remain the
standard of care due to the lack of alternative treatments.
The combination of pipeline BRAF inhibitor dabrafenib and MEK inhibitor trametinib is thought to
be the biggest threat to the current marketed therapies. The potential of this combination therapy
to overcome resistance to BRAF inhibitor monotherapy could allow it to compete strongly in this
setting and take market share from Zelboraf.

2. The limited treatment options in the adjuvant setting will allow the pipeline drugs targeting this
patient population to face fewer barriers to market entry. There are currently two melanoma
vaccines in development in this setting.
Your key questions answered
Identify the market leaders in this competitive indication.
Compare and assess current late-stage pipeline drugs according to market positioning, commercial
potential and clinical efficacy.
Understand how pipeline drugs will be used with current therapies and how the market is accessed
through less competitive treatment settings
Table of contents
OVERVIEW
Catalyst
Summary
EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor key findings
PRODUCT OVERVIEW
Key marketed and pipeline products
Datamonitor’s assessment summary
MARKETED PRODUCT PROFILES
Yervoy (ipilimumab; Bristol-Myers Squibb)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Zelboraf (vemurafenib; Roche/Daiichi Sankyo)

3. Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Other drugs
DTIC-Dome (dacarbazine; Bayer) and generic dacarbazine
Temodar (temozolomide; Merck & Co.)
Interleukin-2
PIPELINE PRODUCT PROFILES
Dabrafenib (GSK-2118436; GlaxoSmithKline)
Drug overview
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Trametinib (GSK-1120212; GlaxoSmithKline)
Drug overview
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Abraxane (albumin-bound paclitaxel; Celgene)

4. Drug overview
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Allovectin-7 (velimogene aliplasmid; Vical)
Drug overview
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
MAGE-A3 ASCI (astuprotimut-r; GlaxoSmithKline)
Drug overview
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
OncoVEX GM-CSF (talimogene laherparepvec; Amgen)
Drug overview
Drug profile
Development overview
SWOT analysis

5. Satisfaction of unmet needs
Clinical and commercial attractiveness
POL-103A (Polynoma/CK Life Sciences)
Drug overview
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Masitinib (AB-1010; AB Science)
Drug overview
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX
Market definition
PharmaVitae Explorer database
Contributing experts
Report methodology

6. List of Tables
Table: Key marketed drugs for melanoma, 2012
Table: Key pipeline drugs for melanoma, 2012
Table: Yervoy – drug profile, 2012
Table: Overview of major melanoma approvals for Yervoy
Table: Overview of pivotal trial data for Yervoy in melanoma, 2012
Table: Datamonitor drug assessment summary of Yervoy for melanoma, 2012
Table: Zelboraf – drug profile, 2012
Table: Overview of major melanoma approvals for Zelboraf
Table: Overview of pivotal trial data for Zelboraf in melanoma, 2012
Table: Datamonitor drug assessment summary of Zelboraf for melanoma, 2012
Table: Dacarbazine – drug profile, 2012
Table: Temodar – drug profile, 2012
Table: Interleukin-2 – drug profile, 2012
Table: Dabrafenib – drug profile, 2012
Table: Clinical development of dabrafenib in melanoma, 2012
Table: Summary of Phase II clinical trial data for dabrafenib in melanoma
Table: Ability of dabrafenib to meet unmet needs in melanoma, 2012
Table: Datamonitor drug assessment summary of dabrafenib for melanoma, 2012
Table: Trametinib – drug profile, 2012
Table: Clinical development of trametinib in melanoma, 2012
Table: Summary of Phase II clinical trial data for trametinib in melanoma
Table: Ability of trametinib to meet unmet needs in melanoma, 2012
Table: Datamonitor drug assessment summary of trametinib for melanoma, 2012
Table: Abraxane – drug profile, 2012

7. Table: Clinical development of Abraxane in melanoma, 2012
Table: Summary of Phase II clinical trial data for Abraxane in melanoma
Table: Ability of Abraxane to meet unmet needs in melanoma, 2012
Table: Datamonitor drug assessment summary of Abraxane for melanoma, 2012
Table: Allovectin-7 – drug profile, 2012
Table: Clinical development of Allovectin-7 in melanoma, 2010
Table: Ability of Allovectin-7 to meet unmet needs in melanoma, 2012
Table: Datamonitor drug assessment summary of Allovectin-7 for melanoma, 2012
Table: MAGE-A3 ASCI – drug profile, 2012
Table: Clinical development of MAGE-A3 ASCI in melanoma, 2012
Table: Datamonitor drug assessment summary of MAGE-A3 ASCI for melanoma, 2012
Table: OncoVEX GM-CSF – drug profile, 2012
Table: Clinical development of OncoVEX GM-CSF in melanoma, 2012
Table: Ability of OncoVEX GM-CSF to meet unmet needs in first-line metastatic melanoma, 2012
Table: Datamonitor drug assessment summary of OncoVEX GM-CSF for melanoma, 2012
Table: POL-103A – drug profile, 2012
Table: Clinical development of POL-103A, 2012
Table: Datamonitor drug assessment summary of POL-103A for melanoma, 2012
Table: Masitinib – drug profile, 2012
Table: Clinical development of masitinib, 2012
Table: Datamonitor drug assessment summary of masitinib for melanoma, 2012
Table: Summary of therapeutic classes in melanoma by ATC code, 2012
List of Figures
Figure: Datamonitor's drug assessment summary of key marketed and pipeline drugs for
melanoma, 2012
Figure: Yervoy’s SWOT analysis for melanoma, 2012

8. Figure: Datamonitor's drug assessment summary of Yervoy for melanoma, 2012
Figure: Zelboraf’s SWOT analysis for melanoma, 2012
Figure: Datamonitor's drug assessment summary of Zelboraf for melanoma, 2012
Figure: Phase III results for first-line dabrafenib in metastatic melanoma
Figure: Dabrafenib’s SWOT analysis for melanoma, 2012
Figure: Datamonitor's drug assessment summary of dabrafenib for melanoma, 2012
Figure: Phase III results for first- or second-line trametinib in metastatic melanoma
Figure: Trametinib’s SWOT analysis for melanoma, 2012
Figure: Datamonitor's drug assessment summary of trametinib for melanoma, 2012
Figure: Phase II results for first-line and second-line Abraxane in metastatic melanoma
Figure: Abraxane’s SWOT analysis for melanoma, 2012
Figure: Datamonitor's drug assessment summary of Abraxane for melanoma, 2012
Figure: Phase II results for second-line Allovectin-7 in metastatic melanoma, 2010
Figure: Allovectin-7’s SWOT analysis for melanoma, 2012
Figure: Datamonitor's drug assessment summary of Allovectin-7 for melanoma, 2012
Figure: Phase II results for MAGE-A3 ASCI in combination with two different adjuvant systems
Figure: MAGE-A3 ASCI’s SWOT analysis for melanoma, 2012
Figure: Datamonitor's drug assessment summary of MAGE-A3 ASCI for melanoma, 2012
Figure: Phase II results for second-line OncoVEX GM-CSF monotherapy for unresectable Stage IIIc
and IV melanoma
Figure: OncoVEX GM-CSF’s SWOT analysis for melanoma, 2012
Figure: Datamonitor's drug assessment summary of OncoVEX GM-CSF for melanoma, 2012
Figure: Phase II results for adjuvant POL-103A in melanoma, 2012
Figure: POL-103A’s SWOT analysis for melanoma, 2011
Figure: Datamonitor's drug assessment summary of POL-103A for melanoma, 2012
Figure: Masitinib’s SWOT analysis for melanoma, 2012

9. Figure: Datamonitor's drug assessment summary of masitinib for melanoma, 2012
Figure: The PharmaVitae Explorer
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