Breast Cancer – Unmet Need – Detailed, Expanded Analysis: Advanced Or Metastatic HER2-Positive Breast Cancer (US/EU)
In the last decades, markedly improved survival benefit has been achieved in the treatment of advanced or metastatic HER2-positive breast cancer. Effective HER2-targeted drugs such as Herceptin, Perjeta, and Kadcyla (all from Roche / Genentech) have greatly contributed to these outcomes. More recently, the second-generation HER2-targeted antibody drug conjugate Enhertu (AstraZeneca / Daiichi Sankyo) was added to the treatment armamentarium after showing unprecedented improvement in efficacy in the refractory setting. Enhertu, along with recently approved novel tyrosine kinase inhibitors such as Tukysa (Pfizer), are rapidly changing the treatment paradigm of this disease. While current therapies are highly effective in disease control, significant clinical opportunity remains for drug developers to overcome resistance to HER2-targeted agents and to limit associated drug toxicity.
Questions answered
- How satisfied are U.S. and European medical oncologists with the current treatment options for metastatic HER2-positive breast cancer?
- What are the treatment drivers and goals in medical oncologists’ prescribing decisions in metastatic HER2-positive breast cancer? How do current therapies, such as AstraZeneca’s Enhertu, perform on these metrics?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European medical oncologists for a hypothetical new metastatic HER2-positive breast cancer drug?
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 60 U.S. and 31 European medical oncologists fielded in February 2023.
Key companies: AstraZeneca, Roche / Genentech, Seagen, Puma Biotechnology.
Key drugs: Enhertu, Kadcyla, Perjeta, Herceptin, Phesgo, Tukysa, Nerlynx.
Table of contents
- Breast Cancer - Unmet Need - Detailed, Expanded Analysis: Advanced Or Metastatic HER2-Positive Breast Cancer (US/EU)
- Executive summary
- Unmet Need - advanced / metastatic HER2-positive breast cancer - executive summary - May 2023
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Regimens for advanced / metastatic HER2-positive breast cancer and rationale for drug selection
- Treatment drivers and goals
- Key findings: attribute importance
- Relative importance of efficacy, safety and tolerability, and convenience of administration to surveyed medical oncologists' prescribing decisions in advanced / metastatic HER2-positive breast cancer
- Importance of efficacy attributes to prescribing decisions in advanced / metastatic HER2-positive breast cancer: United States
- Importance of efficacy attributes to prescribing decisions in advanced / metastatic HER2-positive breast cancer: Europe
- Importance of safety and tolerability attributes to prescribing decisions in advanced / metastatic HER2-positive breast cancer: United States
- Importance of safety and tolerability attributes to prescribing decisions in advanced / metastatic HER2-positive breast cancer: Europe
- Importance of convenience of administration attributes to prescribing decisions in advanced / metastatic HER2-positive breast cancer: United States
- Importance of convenience of administration attributes to prescribing decisions in advanced / metastatic HER2-positive breast cancer: Europe
- Key findings: stated vs. derived importance
- Stated vs. derived importance of key efficacy, safety and tolerability, and convenience of administration to prescribing decisions in advanced / metastatic HER2-positive breast cancer: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, and convenience of administration to prescribing decisions in advanced / metastatic HER2-positive breast cancer: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for advanced / metastatic HER2-positive breast cancer: United States
- Overall performance of key therapies for advanced / metastatic HER2-positive breast cancer: Europe
- Mean overall performance of key therapies for advanced / metastatic HER2-positive breast cancer: United States and Europe
- Relative performance of key therapies for advanced / metastatic HER2-positive breast cancer across select efficacy attributes: United States
- Relative performance of key therapies for advanced / metastatic HER2-positive breast cancer across select efficacy attributes: Europe
- Relative performance of key therapies for advanced / metastatic HER2-positive breast cancer across select safety and tolerability attributes: United States
- Relative performance of key therapies for advanced / metastatic HER2-positive breast cancer across select safety and tolerability attributes: Europe
- Relative performance of key therapies for advanced / metastatic HER2-positive breast cancer across select convenience of administration attributes: United States
- Relative performance of key therapies for advanced / metastatic HER2-positive breast cancer across select convenience of administration attributes: Europe
- Relative performance of key therapies for advanced / metastatic HER2-positive breast cancer across select nonclinical attributes: United States
- Relative performance of key therapies for advanced / metastatic HER2-positive breast cancer across select nonclinical attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in advanced / metastatic HER2-positive breast cancer
- Surveyed medical oncologistsu2019 satisfaction with the performance of key therapies for advanced / metastatic HER2-positive 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 / metastatic HER2-positive 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 / metastatic HER2-positive breast cancer: United States
- Surveyed medical oncologists' ascribed level of unmet need across key efficacy attributes in advanced / metastatic HER2-positive breast cancer: Europe
- Surveyed medical oncologists' ascribed level of unmet need across key safety and tolerability attributes in advanced / metastatic HER2-positive breast cancer: United States
- Surveyed medical oncologists' ascribed level of unmet need across key safety and tolerability attributes in advanced / metastatic HER2-positive breast cancer: Europe
- Surveyed medical oncologists' ascribed level of unmet need across key convenience of administration attributes in advanced / metastatic HER2-positive breast cancer: United States
- Surveyed medical oncologists' ascribed level of unmet need across key convenience of administration attributes in advanced / metastatic HER2-positive breast cancer: Europe
- Key findings: unmet need in advanced / metastatic HER2-positive breast cancer and related indications
- Surveyed medical oncologists' ascribed level of unmet need in advanced / metastatic HER2-positive breast cancer and related indications: United States
- Surveyed medical oncologists' ascribed level of unmet need in advanced / metastatic HER2-positive breast cancer and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the advanced / metastatic HER2-positive breast cancer market and emerging therapy insights
- Opportunity: a novel therapy that extends patient survival and delays progression
- Opportunity: a novel biomarker-driven agent with a unique mechanism of action
- Opportunity: a novel therapy that improves tumor response rate
- Opportunity: a novel therapy with a more manageable safety and tolerability profile
- Areas of opportunity in the advanced / metastatic HER2-positive breast cancer 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
- First-line advanced / metastatic HER2-positive breast cancer target product profile: attribute importance
- Median overall survival (months)
- Median progression-free survival (months)
- Objective response rate (% of patients)
- Incidence of grade 3/4 hematological toxicities (% of patients)
- Incidence of grade 3/4 gastrointestinal toxicities (% of patients)
- Route of administration
- Price per 21-day cycle
- Conjoint analysis-based simulation of a market scenario
- Advanced / metastatic HER2-positive breast cancer market simulation: share of preference of target product profiles included in the market scenario
- Advanced / metastatic HER2-positive breast cancer market simulation: likelihood to prescribe of target product profiles included in the market scenario
- Advanced / metastatic HER2-positive breast cancer market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Kiran Bountra, M.Res., Ph.D., Senior Healthcare Research & Data Analyst, Oncology. Dr. Bountra has a background in the biotechnology sector, specializing in target validation and small-molecule drug discovery. Before joining Clarivate, he worked as a senior scientist at OMass Therapeutics, with a focus on basal cell carcinoma and epilepsy programs. Previously, he trained as a structural biologist, researching the mechanisms of transport proteins involved in drug resistance. He holds a Ph.D. in biochemistry from Imperial College London.
Pragati Tripathi, M.Pharm., Healthcare Research & Data Analyst, Oncology. Before joining Clarivate, Ms. Tripathi was a senior research associate in the intellectual property and research division at Evalueserve in Gurgaon. She conducted secondary research and delivered technology landscape reports in the domain of pharmaceutical sciences and healthcare. She obtained her master’s degree in pharmaceutical chemistry from the Birla Institute of Technology and Science in Pilani.