Breast Cancer – Unmet Need – Detailed, Expanded Analysis: Metastatic HR-Positive/HER2-Negative (US/EU)

Despite considerable progress in the treatment of HR-positive/HER2-negative metastatic breast cancer, the disease remains incurable. The approval and availability of the CDK4/6 inhibitors (Pfizer’s Ibrance, Novartis’s Kisqali and Piqray, and Eli Lilly’s Verzenio / Verzenios) have greatly expanded the treatment options for patients. A pressing need remains for later-line therapies following the development of hormone resistance. Key emerging agents under evaluation in this setting include: Immunomedics’ Trodelvy (sacituzumab govitecan); AstraZeneca’s capivasertib; Radius Health / Menarini’s elacestrant; Polyphor’s balixafortide; Odonate Therapeutics’ tesetaxel; and Athenex’s Oraxol. As competition intensifies in the metastatic HR-positive/HER2-negative breast cancer market, novel therapies will help to address the remaining unmet needs in this patient population.

QUESTIONS ANSWERED

  • What are the most important factors that drive medical oncologists’ prescribing decisions for HR-positive/HER2-negative breast cancer?
  • How do key current therapies, such as Pfizer’s Ibrance and Novartis’s Piqray, perform on key clinical attributes for this patient population?
  • What are the prevailing areas of unmet need and hidden opportunities in this patient population?
  • When considering new treatment options for metastatic HR-positive/HER2-negative breast cancer, what trade-offs are acceptable to surveyed medical oncologists between key clinical attributes and price per cycle?

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 our 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. and 30 European medical oncologists fielded in March 2021.

Key companies: Pfizer, Novartis, Eli Lilly, AstraZeneca.

Key drugs: Ibrance, Kisqali, Verzenio / Verzenios, Piqray, Afinitor, fulvestrant, letrozole, anastrozole, and exemestane.

Table of contents

  • Breast Cancer - Unmet Need - Detailed, Expanded Analysis: Metastatic HR-Positive/HER2-Negative (US/EU)
    • Executive Summary
      • Unmet Need - Breast Cancer - Executive Summary - June 2021
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products/Regimens for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer
      • 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 Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer
        • Importance of Efficacy Attributes to Prescribing Decisions in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Advanced or Metastatic HR-Positive/HER2-Negative Breast 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 Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States
        • Overall Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: Europe
        • Mean Overall Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States and Europe
        • Relative Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Across Select Convenience of Administration Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer
        • Surveyed Medical Oncologists' Satisfaction with the Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Medical Oncologistsu2019 Satisfaction with the Performance of Key Therapies for Advanced or Metastatic HR-Positive/HER2-Negative Breast 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 Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: Europe
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: Europe
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer: Europe
        • Key Findings: Unmet Need in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer and Related Indications
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer and Related Indications: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Market and Emerging Therapy Insights
          • Opportunity: A Novel Therapy That Can Prolong Overall Survival
          • Opportunity: A New Therapy With Extended Progression-Free Survival
          • Opportunity: A Novel Therapy That Improves Tumor Response
          • Opportunity: A Novel Agent 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
          • Median Overall Survival
          • Median Progression-Free Survival
          • Objective Response Rate
          • Incidence of Grade 3/4 Hematological Toxicities
          • Incidence of any Grade Gastrointestinal Toxicities
          • Treatment Discontinuation Due to Adverse Events
          • Price per 28-Day Cycle
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Second- and Subsequent-Line Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Second- and Subsequent-Line Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Second- and Subsequent-Line Advanced or Metastatic HR-Positive/HER2-Negative Breast Cancer Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Bibliography