Malignant Melanoma – Unmet Need – Detailed, Expanded Analysis: BRAF Mutation-Positive Unresectable Or Metastatic Malignant Melanoma
The treatment of BRAF mutation-positive unresectable or metastatic malignant melanoma has been transformed by the development of immune checkpoint inhibitors (e.g., Keytruda, Opdivo, Tecentriq) and BRAF/MEK inhibitors (e.g., Tafinlar, Mekinist, Braftovi, Mektovi). These agents can be used alone or in combination (e.g., Opdivo plus Yervoy, Tecentriq in combination with Zelboraf plus Cotellic), but despite the remarkable survival data demonstrated by combination therapies, patients ultimately experience disease progression. Key challenges that remain include overcoming the relatively low response rates associated with immunotherapies and the relatively short duration of response associated with BRAF/MEK inhibitors and optimizing the sequence of therapies.
QUESTIONS ANSWERED
- How satisfied are U.S. and European medical oncologists with the current treatments 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 immune checkpoint inhibitor and 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?
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. One market scenario is profiled in detail by Clarivate 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 63 U.S. and 31 European medical oncologists fielded in March 2021
Key companies: Bristol Myers Squibb, Merck & Co., Roche, Novartis, Pfizer, Amgen
Key drugs: Opdivo, Yervoy, Keytruda, Tecentriq, Tafinlar, Mekinist, Braftovi, Mektovi, Zelboraf, Cotellic, Imlygic
Table of contents
- Malignant Melanoma - Unmet Need - Detailed, Expanded Analysis: BRAF Mutation-Positive Unresectable Or Metastatic Malignant Melanoma
- Executive Summary
- Unmet Need - BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma - Executive Summary - June 2021
- Introduction
- Overview
- Methodology
- Rationale for Treatment Drivers and Goals Selection
- Rationale for Drug Selection
- Regimens for BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma and Rationale for Drug Selection
- 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
- Importance of Nonclinical Factors to Prescribing Decisions in BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma: United States
- Importance of Nonclinical Factors 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
- Relative Performance of Key Therapies for BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma Across Select Nonclinical Attributes: United States
- Relative Performance of Key Therapies for BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma Across Select Nonclinical Attributes: Europe
- Assessment of Unmet Need
- Key Findings: Unmet Need in BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma
- Surveyed Medical Oncologistsu2019 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 Oncologistsu2019 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 Oncologistsu2019 Ascribed Level of Unmet Need Across Key Efficacy Attributes in BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma: Europe
- Surveyed Medical Oncologistsu2019 Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma: United States
- Surveyed Medical Oncologistsu2019 Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma: Europe
- Surveyed Medical Oncologistsu2019 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
- Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma: United States
- Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors 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 Oncologistsu2019 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: Novel Agents Offering Improved Overall Survival
- Opportunity: A Therapy That Delays Disease Progression
- Opportunity: A Novel Regimen Offering an Improved Tumor Response
- Opportunity: A Novel Regimen with an Improved Safety and Tolerability Profile
- Areas of Opportunity in the BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma Market and Emerging Therapy Insights
- 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 Hepatotoxicity
- Incidence of Immune-Related Adverse Events
- Treatment Discontinuation due to Adverse Events
- Price per 28-Day Cycle
- Conjoint Analysis-Based Simulation of a Market Scenario
- Previously Untreated BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
- Previously Untreated (First-Line) BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
- Previously Untreated (First-Line) BRAF Mutation-Positive Unresectable or Metastatic Malignant Melanoma Market Simulation: Target Product Profiles Included in the Market Scenario
- Appendix
- Bibliography
- Executive Summary
Liseth Parra, Ph.D., is an analyst on the Oncology team at Clarivate. She has extensive background in oncology research and market analysis. She completed a postdoctoral fellowship in oncology at Brigham and Women’s Hospital in Boston, along with commercial work as an oncology research analyst for Kantar Health and as an independent consultant. She also worked as a research fellow at the Novartis Institutes for BioMedical Research in Basel, Switzerland, and at the Fritz Lipmann Institute in Jena, Germany. Dr. Parra completed her doctorate in neurosciences at the University of California in San Diego.