Treatment of BRAF-mutation-positive unresectable or metastatic malignant melanoma has been transformed by the development of several combination regimens that include BRAF and MEK inhibitors, as well as the uptake of immune checkpoint inhibitors as single agents (e.g., Keytruda) and as part of combination regimens (e.g., Opdivo plus Yervoy). Despite the remarkable overall survival and progression-free survival data demonstrated by combination therapies, patients ultimately experience disease progression. Other key efficacy challenges include overcoming the relatively low response rates associated with immunotherapies and the relatively short duration of response associated with BRAF and MEK inhibitors, as well as optimizing the sequence of therapies in this crowded and competitive setting.

QUESTIONS ANSWERED

  • How satisfied are U.S. and European medical oncologists with the current treatment options for BRAF-mutation-positive unresectable or metastatic malignant melanoma ?
  • What treatment drivers and goals are most likely to influence the choice of therapy in this crowded patient population?
  • How do current therapies, such as BRAF/MEK combinations, perform on key treatment drivers and goals?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European medical oncologists for a hypothetical new BRAF-mutation-positive unresectable or metastatic malignant melanoma treatment opportunity?

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Markets covered: United States, United Kingdom, France, Germany.

Primary research: Survey of 60 U.S. medical oncologists and 30 European medical oncologists.

Key drugs: Opdivo, Yervoy, Keytruda, Tafinlar, Mekinist, Zelboraf, Cotellic, Braftovi, Mektovi, Imlygic.

Table of contents

  • Malignant Melanoma - Unmet Need - Detailed, Expanded Analysis: BRAF-Mutation-Positive, Unresectable Or Metastatic Malignant Melanoma
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
      • Rationale for Drug Selection
        • Products / Regimens for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Medical Oncologists' Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma
      • Importance of Efficacy Attributes to Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: Europe
      • Key Findings: Stated vs. Derived Importance
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States
      • Overall Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: Europe
      • Mean Overall Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States and Europe
      • Relative Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Across Select Convenience of Administration Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma
      • Surveyed Medical Oncologists’ Satisfaction with the Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Medical Oncologists’ Satisfaction with the Performance of Key Therapies for BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: Europe
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: Europe
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: United States
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma: Europe
      • Key Findings: Unmet Need in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma and Related Indications
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma and Related Indications: United States
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Market and Emerging Therapy Insights
        • Opportunity: A Therapy That Can Extend Survival
        • Opportunity: A Therapy That Delays Disease Progression
        • Opportunity: A Therapy with a Better Safety and Tolerability Profile
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
        • Assigned Prohibitions for the Conjoint Module
      • Attribute Importance and Part-Worth Utilities
        • Previously Untreated (first-line) BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Target Product Profile: Attribute Importance
        • Median Overall Survival
        • Median Progression-Free Survival
        • Objective Response Rate
        • Incidence of Grade 3/4 Adverse Events
        • Treatment Discontinuation Due to Adverse Events
        • Incidence of Grade 3/4 Immune-Related Toxicities
        • Price per 28-Day Cycle
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Previously Untreated BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Previously Untreated (first-line) BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Previously Untreated (first-line) BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Market Simulations: Target Product Profiles Included in Scenario 1
        • Previously Untreated (first-line) BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Previously Untreated (first-line) BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Previously Untreated (first-line) BRAF-Mutation-Positive, Unresectable or Metastatic Malignant Melanoma Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Sudha Malhotra, Ph.D

Sudha Malhotra joined Decision Resource Group in 2018. She is responsible for performing secondary market analysis including patent research, pricing, and clinical trial assessment for major pharmaceutical markets covering a wide range of oncology indications. She obtained her doctorate degree in life sciences from the National Institute of Immunology, New Delhi, India and has authored several original peer-reviewed journal articles. She holds a bachelor’s degree in microbiology and a master’s degree in biomedical sciences both from the University of Delhi, India.


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