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Product Profiles: Melanoma - Novel combination therapies will increase competition for marketed drugs

Abstract

Synopsis

This report analyses key marketed and pipeline drugs for melanoma. This includes assessment of current and future market strength of approved drugs, key drug development strategies, and commercial and clinical potential of pipeline drugs.

Description

INTRODUCTION

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.

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.
  • 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)
    • 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)
    • 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
    • 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

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
  • 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

FIGURES

  • Figure: Datamonitor's drug assessment summary of key marketed and pipeline drugs for melanoma, 2012
  • Figure: Yervoy's SWOT analysis for melanoma, 2012
  • 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
  • Figure: Datamonitor's drug assessment summary of masitinib for melanoma, 2012
  • Figure: The PharmaVitae Explorer
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