Acute Myeloid Leukemia – Unmet Need – Detailed, Expanded Analysis: First-Line Intensive-Induction-Eligible Acute Myeloid Leukemia (US/EU)
Acute myeloid leukemia (AML) is the most common acute leukemia in adults, originating from mutant myeloid precursor cells. Presently, the AML drug market is dominated by chemotherapy backbones, but recent drug approvals suggest a shift toward targeted agents. Approximately 70% of patients treated with cytotoxic chemotherapy achieve complete remission. Nevertheless, the five-year relative survival rate is only 30.5%. In this report, we focus on the unmet need in the first-line treatment of intensive-induction-eligible AML. These patients currently receive cytotoxic chemotherapy, with or without biomarker-driven targeted therapies (such as Mylotarg and Rydapt) or the topoisomerase II inhibitor Vyxeos.
QUESTIONS ANSWERED
- What treatment drivers and goals are most important to surveyed hematologist-oncologists when selecting a first-line therapy for intensive-induction-eligible AML?
- How do key currently available regimens, including Vyxeos or Rydapt in combination with intensive chemotherapy, perform in terms of key attributes?
- What are the greatest unmet needs and most attractive opportunities in the first-line treatment of intensive-induction-eligible AML?
- What tradeoffs are surveyed hematologist-oncologists willing to make for new and emerging therapies to treat this subpopulation of AML?
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, France, Germany, United Kingdom
Primary research: Survey of 62 U.S. and 31 European hematologist-oncologists fielded in December 2022.
Key companies: Pfizer, Novartis, Jazz Pharmaceuticals
Key drugs: Mylotarg, Rydapt, Vyxeos, cytarabine, daunorubicin, fludarabine, G-CSF, and idarubicin
Table of contents
- Acute Myeloid Leukemia - Unmet Need - Detailed, Expanded Analysis: First-Line Intensive-Induction-Eligible Acute Myeloid Leukemia (US/EU)
- Executive summary
- Unmet Need - first-line intensive-induction-eligible AML - executive summary - March 2023
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Regimens for first-line intensive-induction-eligible acute myeloid leukemia 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 hematologist-oncologists' prescribing decisions in first-line intensive-induction-eligible AML
- Importance of efficacy attributes to prescribing decisions in first-line intensive-induction-eligible AML: United States
- Importance of efficacy attributes to prescribing decisions in first-line intensive-induction-eligible AML: Europe
- Importance of safety and tolerability attributes to prescribing decisions in first-line intensive-induction-eligible AML: United States
- Importance of safety and tolerability attributes to prescribing decisions in first-line intensive-induction-eligible AML: Europe
- Importance of convenience of administration attributes to prescribing decisions in first-line intensive-induction-eligible AML: United States
- Importance of convenience of administration attributes to prescribing decisions in first-line intensive-induction-eligible AML: 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 first-line intensive-induction-eligible AML: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in first-line intensive-induction-eligible AML: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for first-line intensive-induction-eligible AML: United States
- Overall performance of key therapies for first-line intensive-induction-eligible AML: Europe
- Mean overall performance of key therapies for first-line intensive-induction-eligible AML: United States and Europe
- Relative performance of key therapies for first-line intensive-induction-eligible AML across select efficacy attributes: United States
- Relative performance of key therapies for first-line intensive-induction-eligible AML across select efficacy attributes: Europe
- Relative performance of key therapies for first-line intensive-induction-eligible AML across select safety and tolerability attributes: United States
- Relative performance of key therapies for first-line intensive-induction-eligible AML across select safety and tolerability attributes: Europe
- Relative performance of key therapies for first-line intensive-induction-eligible AML across select convenience of administration attributes: United States
- Relative performance of key therapies for first-line intensive-induction-eligible AML across select convenience of administration attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in first-line intensive-induction-eligible AML
- Surveyed hematologist-oncologistsu2019 satisfaction with the performance of key therapies for first-line intensive-induction-eligible AML on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed hematologist-oncologistsu2019 satisfaction with the performance of key therapies for first-line intensive-induction-eligible AML on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed hematologist-oncologists' ascribed level of unmet need across key efficacy attributes in first-line intensive-induction-eligible AML: United States
- Surveyed hematologist-oncologists' ascribed level of unmet need across key efficacy attributes in first-line intensive-induction-eligible AML: Europe
- Surveyed hematologist-oncologists' ascribed level of unmet need across key safety and tolerability attributes in first-line intensive-induction-eligible AML: United States
- Surveyed hematologist-oncologists' ascribed level of unmet need across key safety and tolerability attributes in first-line intensive-induction-eligible AML: Europe
- Surveyed hematologist-oncologists' ascribed level of unmet need across key convenience of administration attributes in first-line intensive-induction-eligible AML: United States
- Surveyed hematologist-oncologists' ascribed level of unmet need across key convenience of administration attributes in first-line intensive-induction-eligible AML: Europe
- Key findings: unmet need in first-line intensive-induction-eligible AML and related indications
- Surveyed hematologist-oncologists' ascribed level of unmet need in first-line intensive-induction-eligible AML and related indications: United States
- Surveyed hematologist-oncologists' ascribed level of unmet need in first-line intensive-induction-eligible AML and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the first-line intensive-induction-eligible AML market and emerging therapy insights
- Opportunity: a novel therapy that extends overall survival
- Opportunity: a novel therapy that improves complete remission
- Opportunity: a novel therapy with an improved safety profile
- Areas of opportunity in the first-line intensive-induction-eligible AML 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 intensive-induction-eligible AML target product profile: attribute importance
- Median overall survival
- Median event-free survival
- Complete response rate
- Incidence of grade u2265 3 febrile neutropenia
- Incidence of grade u2265 3 thrombocytopenia
- Incidence of TEAEs leading to treatment discontinuation
- Price per 28-day cycle
- Conjoint analysis-based simulation of a market scenario
- First-line intensive-induction-eligible AML market simulation: share of preference of target product profiles included in the market scenario
- First-line intensive-induction-eligible AML market simulation: likelihood to prescribe of target product profiles included in the market scenario
- First-line intensive-induction-eligible AML market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Julia Morris, Ph.D., Healthcare Research & Data Analyst, Oncology. Before joining Clarivate, she was a senior bioscientist in the Drug Discovery Unit at Cancer Research UK Manchester Institute. During this time, she developed and conducted assays to assess the effect of preclinical small-molecule inhibitors on in vitro cellular proliferation in breast, ovarian, and uterine cancer cell lines. She earned her Ph.D. in molecular biology from the University of Sheffield and a B.Sc in cellular and molecular medicine with study in industry from the University of Bristol.
Joan Tur, M.Sc., Ph.D., Healthcare Research & Data Analyst, Oncology. Dr. Tur conducts market research and forecasting in a range of oncology indications. He has several years of experience as a pharmaceutical industry analyst with the Cortellis Competitive Intelligence group, serving as the team’s immuno-oncology expert. Prior to joining Clarivate, Dr. Tur was a researcher in inflammation and macrophage biology at the Barcelona Science Park. He holds a Ph.D. in biomedicine, an M.Sc. in immunology, and a B.Sc. in biology from the University of Barcelona.