Small Words, Big Differences: Best Practices in Supportive Care for Patients With AML

Jacqueline S. Garcia, MD, and Arthur Flatau, PhD, discuss acute myeloid leukemia in this IME activity titled "Small Words, Big Differences: Best Practices in Supportive Care for Patients With AML." For the full presentation, please visit us at www.peervoice.com/EHB870.

1. PeerVoice

Small Words, Big Differences: Best Practices in Supportive Care
for Patients With AML

Learning Objectives

Recognize the disease- and treatment-related health burdens faced by patients
with acute myeloid leukemia

Apply best practices in patient communication in order to empower people with
AML to become active partners in care

This PeerVoice independent medical education activity has been developed in
collaboration with Patient Empowerment Network

www.peervoice.com/EHB870 Copyright

2. PeerVoice

Part 1 of 3: Empowering Patients to Make Informed Treatment Decisions

Jacqueline S. Garcia, MD Arthur Flatau, PhD
Dana-Farber Cancer Institute and Patient Advocate
Harvard Medical School Austin, Texas, USA
Brigham & Women's Hospital

Boston, Massachusetts, USA

This PeerVoice independent medical education activity has been developed in
collaboration with Patient Empowerment Network.

Copyright © 2010-2024, Peervoice

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Disclosures

Jacqueline S. Garcia, MD, has no financial interests/relationships or affiliations in
relation to this activity.

Arthur Flatau, PhD, has no financial interests/relationships or affiliations in relation
to this activity.

ligne Tis PeerVolce Independent medical education activity has been developed In
Nela "E collaboration with Patient Empowerment Network.

www.peervoice.com/EHB870 Copyright © 2010-2024, PeerVoice

4. PeerVoice

AML: Prevalence and Epidemiology

AML Burden!?
+ About 62,770 new cases of leukemia diagnosed each year in the US

+ Approximately 20,800 cases are AML, making it one of the most common types of leukemia in
adults

+ Median age at diagnosis: 69 years
+ Overall 5-year survival: 31.7%

Age at Diagnosis 5-Year Survival Rate by Age
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Disease-Related Health Burdens in AML!2

muy Physical Symptoms y

Fatigue, anemia, frequent infections, easy bruising/bleeding

Anxiety, depression due to disease prognosis

muy Economic Burden u.)

High medical costs and loss of productivity

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Treatment-Related Burdens in AM

Current Standard of Care for Those Eligible for Intensive Chemotherapy’?
+ Intensive chemotherapy regimens such as 7+3, CPX-351, and FLAG-IDA
+ Hematopoietic stem cell transplantation (HSCT)

Toxicity and Mortality Risks45

+ Intensive chemotherapy regimens are associated with significant toxicity

+ HSCT carries a high mortality risk, complicating efforts to improve outcomes
for patients with AML

+ These factors contribute to lower survival rates, especially among older
adults

Quality of Life Considerations®

+ 97% of older patients with AML prioritize health-related quality of life
(HRQoL) over the length of life, emphasizing the need to develop strategies
that enhance HRQoL in these patients

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Necessary Diagnostic Data to Facilitate Informed Decisions

Tests Details

Labs/bone marrow studies
Bone marrow biopsy | Flow cytometry, Aspirate review
Blood counts and organ function | CBC with differential and chemistries; Echo

Pathology

Cytogenetics | <1 week

Actionable therapeutic targets: FLT3, IDH1/2, NPMI

Plus, get the myeloid panel!

CEBPA, DDX41, TP53; ASXLI, BCOR, EZH2, RUNXI, SF3B1, SRSF2,
STAG2, U2AFI, ZRSR2

PML:RARA, CBFB:MYHTI, RUNXT:RUNXITI, KMT2A
rearrangements, BCR::ABL1

Genetics

Gene rearrangements

Medical history

Medical history | Comorbidities
Detailed family and bleeding history | Germline leukemias

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Time From Diagnosis to Treatment Does NOT Negatively Impact

the Prognosis of Patients With Newly Diagnosed AML

Real-world data of 2,263 patients treated in the AML registry of the SAL Cooperative Group Germany
>15 days
AML —— 11-15 days Start
Diagnosis ——————=> 6-10 days Induction

—— 0-5 days

Survival Probability

o 2 24 36 48 60
Time

Take: je message: Get the data and closely moi

patients until treatment plan is confirmed

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9. PeerVoice

New Approvals for AML

April2017 August2017 July2018 November 2018 May 2019 May 2022 July 2023

Midostaurin CPX-351 Ivosidenib — Glasdegib Ivosidenib Ivosidenib Quizartinib

NDFLT3™*AML NOE-AMLOr RIRIDHMMAML Unfit ND AML UnfitNO IDHI™ AML Unfit NDIDHFMAML NO FLT3-ITD™ AML
(Plus 7+3) AML-MRC (monotherapy) (Plus LDAC) (monotherapy) (Plus AZA) (Plus 7+3)

|

|

August 2017 September 2017 November November September2020 December 2022
Enasidenib Gemtuzumab 2018 2018 Oral AZA Olutasidenib
R/RIDH2™ AML ozogamicin Venetoclax Gilteritinib (CC-486) BRICHT“ AML
(monotherapy) ND of R/R AML Unfit ND AML RI FLT3™ AML ND AML in CRI (monotherapy)
(Plus IC or (Plus HMAs (monotherapy) (Maintenance!
monotherapy) ‘or LOAC) Monotherapy)

11 new agents approved by the U.S. Food and Drug Administration since 2017

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Despite Many Options, Gaps in Treatment Exist

Although treatment patterns for AML have changed significantly following the ad

Firstline Treatment Regimen Distribution
Among Patients With ND AML, % (N = 5,135)

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No treatment ther targeted

therapı

HSCT
Venetoclax-based
therapy

t of novel therapi

patients continue to receive no active treatment; these patients tended to be older and more fr:

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Combination Venetoclax and Azacitidine Improves Survival in

Frontline AML Ineligible for Intensive Chemotherapy (VIALE-A)

Median duration of study Median overall

Bo SSS Gace
| es ds son
€ Aza+Ven 161/286 (56) 7.6 (<01-30.7) 14.7 (1.9-18.7)
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Months

Phase 3 trial of azacitadine plus placebo/venetoclax for patients with
AML who are older/ineligible for intensive chemotherapy

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Two-Step Approach to Treatment

=

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13. PeerVoice

Abbreviations and References

AML: Prevalence and Epidemiology

Abbreviation(s): AML: acute myeloid leukemia.

Reference(s): 1. American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML).
https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics. html. Accessed July 8, 2024.
2. National Cancer Institute. seer.cancer.gov/statfacts/html. Accessed July 8, 2024.

Disease-Related Health Burdens in AML"?

Reference(s): 1. Chen P et al. Front Public Health. 2024;11:1329529.
2. Yucel E et al. Adv Ther. 2021;38:5002-5024.

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Abbreviations and References (Cont'd)

Treatment-Related Burdens in AML

Abbreviation(s): CPX-351: cytarabine and daunorubicin; FLAG-IDA: fludarabine, cytarabine, granulocyte
colony-stimulating factor, and idarubicin.

Reference(s): 1. Kantarjian HM et al. J Clin Oncol. 2012:30:2670-2677.

2. Feldman EJ et al. J Clin Oncol. 201,29:979-985.

3.US. Food & Drug Administration. FDA approves first treatment for certain types of poor-prognosis acute myeloid
leukemia. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-certain-types-
poor-prognosis-acute-myeloid-leukemia. Accessed July 8, 2024.

4. Kantarjian H. Am J Hematol. 2016;
5. Kantarjian H. Blood Cancer J. 202
6. Sekeres MA et al. Leukemia, 2004;18:809-816.

Necessary Diagnostic Data to Facilitate Informed Decisions

Abbreviation(s): CBC: complete blood count.
Reference(s): Dohner H et al. Blood. 2022;140:1345-1377.

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Abbreviations and References (Cont'd)

Time From Diagnosis to Treatment Does NOT Negatively Impact the Prognosis of Patients With
Newly Diagnosed AML

Reference(s): Rollig C et al. Blood. 2020;136:823-830.

New Approvals for AML

Abbreviation(s): AML-MRC: AML with myelodysplasia-related changes; AZA: azacytidine; HMAs: hypomethylating
agents; IC: induction chemotherapy; LDAC: low-dose cytarabine; ND: newly diagnosed; R/R: relapsed/refractory;
t-AML: therapy-related AML.

Despite Many Options, Gaps in Treatment Exist

Abbreviation(s): ASH: American Society of Hematology; CIT: chemotherapy-induced thrombocytopenia.
Reference(s): Huntington SF et al. 65th American Society of Hematology Annual Meeting & Exposition (ASH 2023);
Abstract 2428.

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Abbreviations and References (Cont'd)

Combination Venetoclax and Azacitidine Improves Survival in Frontline AML Ineligible for
Intensive Chemotherapy (VIALE-A)

Abbreviation(s): Pbo: placebo; Ven: venetoclax.

Reference(s): DiNardo CD et al. N Engl J Med. 2020;383:617-629.

Two-Step Approach to Treatment

Reference(s): Jacqueline C. Garcia, MD. PeerVoice interview; June 2024.

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17. PeerVoice

t 2 of 3: Best Practices in Coaching Patients’ Mental Health and Resilience

Jacqueline S. Garcia, MD Arthur Flatau, PhD
Dana-Farber Cancer Institute and Patient Advocate
Harvard Medical School Austin, Texas, USA
Brigham & Women's Hospital

Boston, Massachusetts, USA

This PeerVoice independent medical education activity has been developed in
collaboration with Patient Empowerment Network.

Copyright © 2010-2024, PeerVoice

18. PeerVoice

Disclosures

Jacqueline S. Garcia, MD, has no financial interests/relationships or affiliations in
relation to this activity.

Arthur Flatau, PhD, has no financial interests/relationships or affiliations in relation
to this activity.

ligne Tis PeerVolce Independent medical education activity has been developed In
Nela "E collaboration with Patient Empowerment Network.

www.peervoice.com/EHB870 Copyright © 2010-2024, PeerVoice

19. PeerVoice

Impact of Mental Health on AML Outcomes

Correlations of Anxiety and Depression With
Event-Free Survival (EFS) in Patients Treated for AML

os

os

EFS

04

02 71 Anxiety (n = 81)

Non-anxiety (n = 127)

EFS

os

os

04

02

P=.052

|. Depression (n = 58)
Non-depression (n = 150)

6 2 B 24 30
Time, Months

o

0 6 2 B 24 30 36
Time, Months

P value of < .05 was applied as the threshold for significance.

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A Diagnosis of AML Can Cause Traumatic Stress

Multidisciplinary
team required

Other important
players:
PCP and other
specialists

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Quality of Life and Mood of Older Patients With AML Are Similar

Regardless of Intensive Treatment

‘Anxiety Symptoms Depression Symptoms
e 5°
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Time A

Intensive

—— Non-intensive

PHQ-9

H— Confidence interval
Baseline Week2 Week4 Weok8 Wook12 Week 24
Time

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Survival and QoL Benefits: QoL Is Just as Important as Length

of Life

4 Regular Article

MYELOID NEOPLASIA
Multisite 11-year experience of less-intensive vs intensive
therapies in acute myeloid leukemia

Mohamed L Sorrr,'2 Bary E Storer" Amir T. Fathi? Andrew Brunner Aaron T. Gerd," Mikkael A. Sekceras.* Sudipto Mukherjee,”
Bruno C, Medios,’ Eunice S. Wang,“ Part Vachhani Paul J. Sham” Estaban Pai,” Mahmoud Elan, Kohinde Adobo,
Sein Luger? Marta R. Ber. Dovid ir Tanya M. Widen, Jamie Kopitar. Jue Sith” Michal Garn,

Karesh Kojowi,'? Wendy Leisening Lynn Onstad Jennifer E. Nyland," Pamela S. Becker, Jeannine 5. MeCune, 2
Stephanie J. Lee"? Brenda M, Sandmaier,’? Frederik R. Appelbaum,'? and Elihu H. Estey"

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Abbreviations and References

Impact of Mental Health on AML Outcomes

Abbreviation(s): AML: acute myeloid leukemia; EFS: event-free survival.
Reference(s): Ding T et al. Medicine (Baltimore). 2019;98(43):e17314.

A Diagnosis of AML Can Cause Traumatic Stress

Abbreviation(s): PCP: primary care physician.
Reference(s): Nissim R et al. Leuk Res. 2013;37:496-502.
Lockwood BJ et al. J Adolesc Young Adult Oncol. 2023;12:592-598.

Quality of Life and Mood of Older Patients With AML Are Similar Regardless of Intensive
Treatment

Abbreviation(s): HADS: Hospital Anxiety and Depression Scale; PHQ-9: Patient Health Questionnaire-9.
Reference(s): El-Jawahri A et al, Leukemia. 2019;33:2393-2402.

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Abbreviations and References (Cont'd)

Survival and Qol Benefits: QoL Is Just as Important as Length
of Life

Abbreviation(s): QoL: quality of life.
Reference(s): Sorror M et al. Blood. 2021,138:387-400.

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Part 3 of 3: Expanding Management Plans Beyond Treatment:
The Importance of Physical Health and Acti

Jacqueline S. Garcia, MD Arthur Flatau, PhD
Dana-Farber Cancer Institute and Patient Advocate
Harvard Medical School Austin, Texas, USA
Brigham & Women's Hospital

Boston, Massachusetts, USA

This PeerVoice independent medical education activity has been developed in
collaboration with Patient Empowerment Network.

Copyright © 2010-2024, Peervoice

26. PeerVoice

Disclosures

Jacqueline S. Garcia, MD, has no financial interests/relationships or affiliations in
relation to this activity.

Arthur Flatau, PhD, has no financial interests/relationships or affiliations in relation
to this activity.

ligne Tis PeerVolce Independent medical education activity has been developed In
Nela "E collaboration with Patient Empowerment Network.

www.peervoice.com/EHB870 Copyright © 2010-2024, PeerVoice

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Defining Baseline Fitness in AML

Operation Criteria to Define Unfitness for Intensive Chemotherapy in A\

1 | An age older than 75 years

Congestive heart failure or documented cardiomyopathy with an EF <50%

Documented pulmonary disease with DLCO <65% or FEVI <65%, or dyspnea at rest or requiring
oxygen, or any pleural neoplasm or uncontrolled lung neoplasm

On dialysis and age older than 60 years or uncontrolled renal carcinoma

2
3
4

Liver cirrhosis Child B or C, or documented liver disease with marked elevation of transaminases
5 | (23 times normal values) and an age older than 60 years, or any biliary tree carcinoma or
uncontrolled liver carcinoma or acute viral hepatitis

6_ | Active infection resistant to anti-infective therapy

Current mental illness requiring psychiatric hospitalization, institutionalization or intensive
7 | outpatient management, or current cognitive status that produces dependence (as confirmed by
the specialist) not controlled by the caregiver

8 | ECOG performance status 23 not related to leukemia

Any other comorbidity that the physician judges to be incompatible with conventional intensive
chemotherapy

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Room for Improvement of Baseline Performance

Baseline Cognitive Function

Survival Probability

© 90 Go O O Wo WO 20 NO DO IDO 90) 20 41 20 AD DO 54D ETO O

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7 3MS Score (P = .002): 7

Time, Days

Physical Performance

SPPB Score (P=.018): 77 2

Survival Probability

EILIIILEIELTEELIICEIT.)

Time, Days

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Abbreviations and References

Defining Baseline Fitness in AML

Abbreviation(s): AML: acute myeloid leukemia; DLCO: diffusing capa
ECOG: Eastern Cooperative Oncology Group; EF: ejection fraction; FE
Reference(s): Ferrara F et al. Leukemia. 2013;27:997-999.

of the lungs for carbon monoxide;
jorced expiratory volume in 1 second.

Room for Improvement of Baseline Performance

Abbreviation(s): 3MS: Modified Mini-Mental State; SPPB: Short Physical Performance Battery.
Reference(s): Klepin HD et al. Blood. 2013;121:4287-4294.

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