Acute Myeloid Leukemia (AML) - The Changing Landscape of Treatment in AML, Executive Deck 2020

Acute myelogenous leukemia (AML) Disease Landscape provides comprehensive market intelligence with epidemiology, keen insight into current treatment paradigms, in-depth pipeline coverage ( ~ 470 unique industry-sponsored studies) and clinical trial landscape supported by detailed recent results (~ 96 trial's results) from ASH 2019, ASCO 2020 and EHA 2020. The drugs are further classified according to the class of therapies: antibody drug conjugates, bispecific antibodies, tri-specific and monoclonal antibodies, CAR-T therapies & T cells therapies, vaccines, small molecules and others.

Acute myelogenous leukemia (AML) is a cancer that starts in blood stem cells. Commonly known as acute myeloid leukemia, acute myelocytic leukemia, acute myeloblastic leukemia, acute granulocytic leukemia or acute non-lymphocytic leukemia (ANLL). Once diagnosed, AML disease is described as untreated, in remission, or recurrent. The executive deck covers the AML overview, definition, diagnosis, percentage of patients based on mutation frequency, and treatment practice related unmet needs.

Acute Myeloid Leukemia (AML) Epidemiology

• The global incidence of AML is increasing 105,842 cases in 2019 to 119,247 in 2030, with a potential growth rate of 1.09% during the forecast period.

• Cases of AML with diagnosed incidence in the US will increase to 21,530 by 2030

• Cases of AML with diagnosed incidence in the EU will increase to 17,139 by 2030

• AML Five-year survival rate is 28.7% in the US and 24% in the EU

Acute Myeloid Leukemia (AML) Current Treatment Landscape

The main treatment for most types of AML is chemotherapy, along with a targeted therapy drug and followed by a stem cell transplant. In patients who are under 60 years old, induction chemotherapy for AML is given. The goal of induction therapy is to induce a remission, usually defined as less than 5% blast cells found in the bone marrow. Once remission is achieved, consolidation therapy is given. In this phase, chemotherapy is continued for 4-5 more cycles (4-6 months), generally with cytarabine alone, in higher doses.

The treatment of those over the age of 60 include recently approved new targeted therapies for AML-i.e., venetoclax, glasdegib, gemtuzumab, gemtuzumab, enasidenib, mitoxantrone, decitabine, azacitidine, midostaurin and clofarabine .

Changing Treatment Landscape of AML: Clinical Trial Pipeline coverage

• ~ 470 unique industry-sponsored studies have been covered for acute myeloid leukemia, of which Phase I studies are 192, Phase I / II studies are 128, Phase II studies are 97, Phase II studies / III are 4 and Phase III studies are 49

• Recent AML results are covered from ASH 2019, ASCO 2020 and EHA 2020 conferences (~ 96 trial's results) .

• Of all the studies, the drugs under consideration for the first line were ~ 81, the second line were ~ 247 and the second line + were 86 and ~ 81 studies were not specified.

• Specific mutation studies show that there are approximately 18 studies for IDH-related mutations, 25 studies for FLT-3 mutations (of which 11 studies related to FLT-3 ITD mutations were 11).

• ~ 175 studies are being tested for refractory and relapsing patients while ~ 46 studies are being tested for patients with newly diagnosed AML

• The drugs are further classified according to the class of therapies: antibody drug conjugates, bispecific antibodies, tri-specific and monoclonal antibodies, CAR-T therapies and T cells therapies, vaccines, small molecules and others.

Table of Contents

Section 0: AML Executive Summary

Section 1: Acute Myeloid Leukemia Overview

• AML Disease Background
• AML Disease Definition
• AML Symptoms
• AML WHO Classification and Staging System

Section 2: AML Diagnosis

• AML Mutation Patterns

• AML Frequency and Clinical Significance of Gene Mutations in Adults

Section 3: AML Epidemiology

• Epidemiology of AML by G7 Countries
• Forecasted AML Cases to 2030

Section 4: AML Current Marketed Landscape

• AML Treatment Algorithm 2020 [Fit & Unfit]
• AML Marketed Therapies
• AML Treatment Practice based Unmet Needs

Section 5: AML Emerging Therapy Landscape

• AML Emerging Landscape by Class of Therapies & Mechanism of Action

• ADCs, Trispecific Antibodies, Bi-specific Antibodies & Monoclonal Antibodies

• CAR-T Cell Therapies, T-Cell therapies, Cell therapy & CAR-T (NK Cells)

• Small Molecules

• Vaccines and vaccine Adjuvant

• Others

• AML Key Comparative Analysis (Phase III)

• Clinical Trials Landscape of AML

• Phase III, Phase II & Phase I

• AML EHA 2020, ASCO 2020, ASH 2019 Conference Results covered

• AML drugs covered by Line of Therapies (LOT), Patient Segment (Newly Diagnosed, Mutation specific, Relapsed or Refractory & Fit or Unfit), Mechanism of Action, Trial Phase, Company and other details