This Unmet Need report focuses on the treatment of previously treated RAS and BRAF  mutation-positive metastatic colorectal cancer. Currently, the NCCN guidelines and treatment practices for metastatic colorectal cancer include the determination of tumor gene status for RAS (KRAS / NRAS) and BRAF  mutation-positive patients. In second- and later-line settings, RAS and BRAF mutation-positive patients are treated with anti-VEGF therapies, such as Avastin (Genentech/Roche), Cyramza (Eli Lilly), Stivarga (Bayer), and Zaltrap (Sanofi / Regeneron), with or without chemotherapy. The novel treatment regimen, consisting of BRAF + MEK inhibitors, Braftovi + Mektovi (Pfizer / Array BioPharma), in combination with the anti-EGFR therapies Erbitux (Eli Lilly / Merck KGaA) or Vectibix (Amgen), is recommended for the subsequent treatment of BRAF  mutation-positive patients. Nevertheless, less-toxic, more-efficacious therapies are needed for the subsequent treatment of these two colorectal cancer subpopulations.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for previously treated RAS / BRAF  mutation-positive metastatic colorectal cancer?
  • What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for previously treated RASBRAF  mutation-positive metastatic colorectal cancer?
  • What are the prevailing areas of unmet need and opportunity in previously treated RAS / BRAF  mutation-positive metastatic colorectal cancer?
  • What trade-offs across different clinical attributes and prices are acceptable to U.S. and European medical oncologists for a hypothetical new RAS / BRAF  mutation-positive metastatic colorectal cancer drug?

PRODUCT DESCRIPTION

Provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.

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

Primary research: Survey of 60 U.S. and 32 European medical oncologists fielded in April 2020

Key companies: Pfizer / Array BioPharma, Eli Lilly / Merck KGaA, Amgen, Roche / Genentech, Bayer, Taiho  Pharmaceutical

Key drugs: Braftovi, Erbitux, Vectibix, Avastin, Cyramza, Stivarga, Lonsurf

Table of contents

  • Colorectal Cancer - Unmet Need - Detailed, Expanded Analysis (US/EU) Previously Treated RAS And BRAF Mutation-Positive Metastatic Colorectal Cancer
    • Executive Summary: Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer
      • Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer - UN Executive Summary - August 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Regimens for RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer 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 Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer
        • Importance of Efficacy Attributes to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: 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 Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Overall Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
        • Mean Overall Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States and Europe
        • Relative Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer
        • Surveyed Medical Oncologists' Satisfaction with the Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Medical Oncologists’ Satisfaction with the Performance of Key Therapies for Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer 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 Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer: Europe
        • Key Findings: Unmet Need in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer and Related Indications
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer and Related Indications: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Market and Emerging Therapy Insights
          • Opportunity: Novel Agents with Significant Efficacy Improvement for RAS Mutation-Positive Patients
          • Opportunity: A New Treatment Option with Longer Survival Rates for BRAF Mutation-Positive Patients
          • Opportunity: A Novel Regimen with an Improved 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 Treated RAS and BRAF Mutation-Positive Colorectal Cancer Target Product Profile: Attribute Importance
          • Median Overall Survival
          • Median Progression-Free Survival
          • Objective Response Rate
          • Incidence of Grade 3/4 Hematological Toxicities
          • Incidence of Grade 3/4 Gastrointestinal Toxicities
          • Incidence of Grade 3/4 Dermatological Toxicities
          • Price per 28-day Cycle
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Previously Treated RAS and BRAF Mutation-Positive Metastatic Colorectal Cancer Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Bibliography

    Author(s): Liseth Parra

    Liseth M Parra, Ph.D., is an analyst on the Oncology team at Decision Resources Group with an extensive background in oncology research and market analysis. Prior to joining DRG, Liseth generated valuable offerings and comprehensive strategic solutions for leading R&D clinical, commercial, and marketing teams in oncology as a research analyst for Kantar Health and as an independent consultant. Liseth holds a Ph.D. in neurobiology from the University of California, San Diego and completed a postdoctoral fellowship in oncology at the Brigham and Women’s Hospital, Harvard Medical School. Liseth supports DRG’s syndicated oncology research offerings, focusing on malignant melanoma disease landscape and forecast analysis.


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