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Acute Myeloid Leukemia (AML) -The Changing Landscape of Treatment in AML, Executive Deck 2022

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Acute myelogenous leukemia (AML) Disease Landscape provides comprehensive market intelligence with epidemiology, keen insight into current treatment paradigms, in-depth pipeline coverage ( ~ 500 unique industry-sponsored studies) and clinical trial landscape supported by detailed recent results from ASH 2022, ASCO 2022 and EHA 2022. 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.

SKU: MM2023002 Category:

Description

Acute myelogenous leukemia (AML/Acute Myeloid Leukemia) 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.

Consistent with the ongoing trend to classify AML based on genetic profile, the 2022 World Health Organization (WHO) classification scheme lists 10 genetic mutations or fusions or chromosomal rearrangements related to defined and different subtypes of AML. Up to 96% of AML tumors contain at least 1 driver mutation, and 86% contain at least 2.
The KMT2A rearrangement and the NPM1 mutation each defines its own WHO classification scheme; these genetic variations are targeted by multiple drugs in early clinical trials, as discussed below. Other mutations (eg, those affecting FLT3, TP53, IDH1, and IDH2), while not defining discreet subtypes, have become actionable targets within the past 5 years. Mutations in the TP53 gene classify the tumor in the poor/adverse risk category according to the European Leukemia Net (ELN) 2022 stratification.
Mixed lineage leukemia–rearranged (MLLr) AML (also known as KMT2A-rearranged leukemia) also falls into the poor/adverse risk classification by the ELN.4 Patients with TP53 or KMT2A mutations have a 5-year survival probability of 25%. The presence of the FLT3 internal tandem duplication mutation classifies a tumor to be in the intermediate-risk category. Second-generation drugs targeting FLT3 (eg, quizartinib, crenolanib, gilteritinib) are in late-stage clinical trials.

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.

Major Unmet Needs in Clinics

  • The major areas of clinical unmet need in AML include both Molecular Distinct and diagnosis. This has now become critical for identifying appropriate prognosis while selecting the optimal frontline treatment whether it’s a targeted therapy or immunotherapy combination approach. This is now has been incorporated in the ELN 2022 as well as the NCCN updated guidelines with recommendations to check all patients for FLT3, IDH1, IDH2, NMP1, TET2, WT1, DNMT3A, and TP53 genes mutations and co-binding factors of normalities as well as translocation 1517 and other mutations. They are not all targetable, but they all have important impact on prognosis but also the decision making.
  • The other big area of unmet need in the clinic is the MRDs (measurable residual disease ). We all know now the number of papers have shown that MRD is critical for outcomes and presence of MRDs is associated with adverse outcomes. There is no uniform and consistent way of knowing its prognosis and different centers are doing diff approaches. I think this is the area where there is a need to reconcile, and efforts are needed to develop national and centralized MRD techniques and that would be eventually used to develop MRD directed Clinical Trials.
  • The third area of unmet medical need is high risk cytogenetics and molecular features. This includes ofcourse TP53 which is the most adverse or difficult but there are more cytogenetics i.e., deletion 7, deletion 5…there we are developing new therapies in combinations as outcome is poor with median survival less than 8 to 10 months for this most adverse risk groups.

Changing Treatment Landscape of AML: Clinical Trial Pipeline coverage

  • ~ 500 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 2022, ASCO 2022 and EHA 2022 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.

Additional information

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Coverage Agenda

  • 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 2022 [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 2022, ASCO 2022, ASH 2022 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

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