EGFR-mutation-status determination is a mandatory step in the treatment algorithm for patients with advanced non-small-cell lung cancer (NSCLC), highlighting the importance of biomarker-driven targeted therapies in this indication. EGFR tyrosine kinase inhibitors (TKIs)—Tarceva (Roche/ Genentech), Iressa (AstraZeneca), Tagrisso (AstraZeneca), and Gilotrif/Giotrif (Boehringer Ingelheim)—have been the conventional first-line choice of therapy in EGFR-mutation-positive metastatic nonsquamous NSCLC for many years. In 2018, the next-generation EGFR TKI Vizimpro (Pfizer) was approved in the United States for the first-line treatment of patients with EGFR mutations. The PD-1 inhibitor Opdivo (Bristol-Myers Squibb) for treatment of EGFR-mutation-positive metastatic nonsquamous NSCLC is another option for patients who have progressed on EGFR TKIs. However, resistance to EGFR TKIs and treatment-related adverse events remain key unmet needs in the metastatic setting, generating opportunity for novel therapies to gain an upper hand over the existing drugs in the NSCLC treatment landscape.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for EGFR-mutation-positive metastatic nonsquamous NSCLC?
  • How do current therapies, such as Opdivo, perform on key treatment drivers and goals for EGFR-mutation-positive metastatic nonsquamous NSCLC?
  • What are the prevailing areas of unmet need and opportunity in EGFR-mutation-positive metastatic nonsquamous NSCLC?
  • What trade-offs across different clinical attributes and price are acceptable to surveyed oncologists for hypothetical new treatment options in first-line EGFR-mutation-positive metastatic nonsquamous NSCLC?

PRODUCT DESCRIPTION

Unmet Need 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 61 medical oncologists in US and 30 medical oncologists in Europe fielded in March 2019.

Key companies: Astellas, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Pfizer, Teva.

Key drugs: Tarceva, Iressa, Gilotrif/Giotrif, Tagrisso, Vizimpro, Avastin (in combination with paclitaxel and carboplatin), Opdivo.

Table of contents

  • Non-Small-Cell Lung Cancer - Unmet Need - Detailed, Expanded Analysis: EGFR-positive Metastatic Non-squamous NSCLC (US & EU)
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
      • Rationale for Drug Selection
        • Regimens for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Importance of Efficacy Attributes to Prescribing Decisions in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: 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 EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States
      • Overall Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: Europe
      • Mean Overall Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States and Europe
      • Relative Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC Across Select Convenience of Administration Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC
      • Surveyed Medical Oncologists’ Satisfaction with the Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Medical Oncologists’ Satisfaction with the Performance of Key Therapies for EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC 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 EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: Europe
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: Europe
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: United States
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC: Europe
      • Key Findings: Unmet Need in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications: United States
      • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications Market and Emerging Therapy Insights
        • Opportunity: A Novel Therapy That Can Prolong Overall Survival
        • Opportunity: A New Therapy That Improves Progression-Free Survival and Elicits a More-Durable Response
        • Opportunity: A Novel Agent with Improved Safety and Tolerability to Improve Patients' Quality of Life
    • 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
        • EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications Target Product Profile: Attribute Importance
        • Median Overall Survival (months)
        • Median Progression-Free Survival (months)
        • Objective Response Rate (% of patients)
        • Incidence of Any Grade Diarrhea (% of patients)
        • Incidence of Any Grade Immune-Mediated Toxicities (% of patients)
        • Incidence of Any Grade Rash (% of patients)
        • Price per 28-Day Cycle
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications Market Simulations: Target Product Profiles Included in Scenario 1
        • EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • EGFR-Mutation-Positive Metastatic Nonsquamous NSCLC and Related Indications Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Vandana, M.Pharm.

Vandana Singh, M.Pharm., is an associate analyst on the Oncology team at DRG, part of Clarivate. Prior to joining DRG, she was a business analyst in digital marketing at Iquanti in Bangalore. She also conducted competitive intelligence, forecasting, and pipeline analysis at WNS in Noida. She obtained her master’s degree in pharmacology from the University of Delhi.


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