Providing Cutting-Edge Care for Cholangiocarcinoma: Transforming the Patient Journey
PeerVoice
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Jul 22, 2024
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About This Presentation
David Malka, MD, PhD, Anna Saborowski, MD, PD, and Elisabeth Baucells, discuss cholangiocarcinoma in this CME activity titled "Providing Cutting-Edge Care for Cholangiocarcinoma: Transforming the Patient Journey." For the full presentation, please visit us at www.peervoice.com/XCA870.
Slide Content
PeerVoice
Providing Cutting-Edge Care for Cholangiocarcinoma: Transforming the
Patient Journey
Learning Objectives
+» Identify the most appropriate modalities for, and timing of,
molecular testing to facilitate use of targeted therapies for
cholangiocarcinoma (CCA)
Design comprehensive, appropriately sequenced treatment
regimens for CCA, which integrate targeted therapies in patients
with actionable alterations
Monitor and manage the safety and effectiveness of targeted
treatment regimens for CCA
Copyright © 2010-2024, PeerVoice
Providing Cutting-Edge Care for Cholangiocarcinoma: Transforming the
Patient Journey
Learning Objectives
+» Identify the most appropriate modalities for, and timing of,
molecular testing to facilitate use of targeted therapies for
cholangiocarcinoma (CCA)
Design comprehensive, appropriately sequenced treatment
regimens for CCA, which integrate targeted therapies in patients
with actionable alterations
Monitor and manage the safety and effectiveness of targeted
treatment regimens for CCA
Copyright © 2010-2024, PeerVoice
PeerVoice
Part 1 of 2: Appreciating the Patient Experience With Cholangiocarcinoma
David Malka, MD, PhD
Head of Medical Oncology
Institute Mutualiste Montsouris
Paris, France
Anna Saborowski, MD, PD
Clinician Scientist
Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology
Hannover Medical School
Hannover, Germany
Elisabeth Baucells
Board Member
ATUVIBI
Madrid, Spain
Copyright © 2010-2024, PeerVoice
Part 1 of 2: Appreciating the Patient Experience With Cholangiocarcinoma
David Malka, MD, PhD
Head of Medical Oncology
Institute Mutualiste Montsouris
Paris, France
Anna Saborowski, MD, PD
Clinician Scientist
Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology
Hannover Medical School
Hannover, Germany
Elisabeth Baucells
Board Member
ATUVIBI
Madrid, Spain
Copyright © 2010-2024, PeerVoice
PeerVoice
Disclosures
David Malka, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for AbbVie Inc. (relationship ended); Amgen Inc; F. Hoffmann-La Roche Ltd. Foundation Medicine, Inc;
LEO Pharma A/S; Sanofi (relationship ended); Veracyte, Inc. (relationship ended); and Viatris Inc. (relationship
ended).
Advisory Board for AstraZeneca; Bayer AG; Bristol Myers Squibb Company; Incyte; Merck KGaA; Merck Sharp &
| Dohme Corp; Pierre Fabre Group; Servier SAS; and Taiho Oncology, Inc.
Other Financial or Material Support in the form of travel expenses for medical meetings from Amgen Inc; Bayer
AG: Bristol Myers Squibb Company; F. Hoffmann-La Roche Ltd, Merck KGaA; Merck Sharp 8: Dohme Corp; Pierre
Fabre Group; Sanofi (relationship ended); Servier SAS; and Viatris Inc. (relationship ended).
Anna Saborowski, MD, PD, has a financial interest/relationship or affiliation in the form of:
Honoraria from lecture work with AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd; Eli Lily and
‘Company; F. Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc; Merck Sharp 8: Dohme Corp; and Servier
SAS.
Advisory Board or Panel for Eisai Co, Lt
F. Hoffmann-La Roche Ltd; Incyte; and Merck Sharp & Dohme Corp.
Elisabeth Baucells has a financial interest/relationship or aff
Consultancy Fees from Curium and Sequentia Biotech SL.
on in the form of:
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Disclosures
David Malka, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for AbbVie Inc. (relationship ended); Amgen Inc; F. Hoffmann-La Roche Ltd. Foundation Medicine, Inc;
LEO Pharma A/S; Sanofi (relationship ended); Veracyte, Inc. (relationship ended); and Viatris Inc. (relationship
ended).
Advisory Board for AstraZeneca; Bayer AG; Bristol Myers Squibb Company; Incyte; Merck KGaA; Merck Sharp &
| Dohme Corp; Pierre Fabre Group; Servier SAS; and Taiho Oncology, Inc.
Other Financial or Material Support in the form of travel expenses for medical meetings from Amgen Inc; Bayer
AG: Bristol Myers Squibb Company; F. Hoffmann-La Roche Ltd, Merck KGaA; Merck Sharp 8: Dohme Corp; Pierre
Fabre Group; Sanofi (relationship ended); Servier SAS; and Viatris Inc. (relationship ended).
Anna Saborowski, MD, PD, has a financial interest/relationship or affiliation in the form of:
Honoraria from lecture work with AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd; Eli Lily and
‘Company; F. Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc; Merck Sharp 8: Dohme Corp; and Servier
SAS.
Advisory Board or Panel for Eisai Co, Lt
F. Hoffmann-La Roche Ltd; Incyte; and Merck Sharp & Dohme Corp.
Elisabeth Baucells has a financial interest/relationship or aff
Consultancy Fees from Curium and Sequentia Biotech SL.
on in the form of:
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
Why (Am | Interested
Courtesy of Elisabeth Baucolls
Why (Am | Interested
Courtesy of Elisabeth Baucolls
PeerVoice
Diagnosis
Psychological
impact
CCA: cholangiocarcinoma.
Courtesy of Elisabeth Baucells.
www.peervoice.com/XCA870
Treatment
Support
Networks
Copyright © 2010-2024, PeerVoice
Diagnosis
Psychological
impact
CCA: cholangiocarcinoma.
Courtesy of Elisabeth Baucells.
www.peervoice.com/XCA870
Treatment
Support
Networks
Copyright © 2010-2024, PeerVoice
PeerVoice
Silent
symptoms
Delay in Diagnosis Misdiagnosis
“It took 12 months for a proper
diagnosis. Doctors in my
community hospital made the
incorrect diagnosis without
hesitating.”
Courtesy of Elisabeth Baucells.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Silent
symptoms
Delay in Diagnosis Misdiagnosis
“It took 12 months for a proper
diagnosis. Doctors in my
community hospital made the
incorrect diagnosis without
hesitating.”
Courtesy of Elisabeth Baucells.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
What Does a CCA Diagnosis Mean for Patients?
“At first, | struggled to grasp the severity, but "its like being on a
then | was told that treatments weren't 100% roller coaster in
effective. Facing this reality felt like staring the dark. You don't
into an abyss.” know when the
next turn or drop
"Ifelt like no one is coming.”
understood what | “After chemotherapy and unsuccessful surgeries,
was going through, the oncologist told me there were no more
not even my doctors options and to come back in six months, without
at first.” mentioning any other investigational treatments.”
Courtesy of Elisabeth Baucolls
www.peervoice.com/XCA870 Copyright © 2010-2024, Peervoice
What Does a CCA Diagnosis Mean for Patients?
“At first, | struggled to grasp the severity, but "its like being on a
then | was told that treatments weren't 100% roller coaster in
effective. Facing this reality felt like staring the dark. You don't
into an abyss.” know when the
next turn or drop
"Ifelt like no one is coming.”
understood what | “After chemotherapy and unsuccessful surgeries,
was going through, the oncologist told me there were no more
not even my doctors options and to come back in six months, without
at first.” mentioning any other investigational treatments.”
Courtesy of Elisabeth Baucolls
www.peervoice.com/XCA870 Copyright © 2010-2024, Peervoice
PeerVoice
CCA and Patients’ Challenges h Treatments
Limited
therapeutic
options
Delays in
molecular
testing
Limited
access to
innovative
treatments
Surgery
Courtesy of Elisabeth Baucolls
Limited
access to
clinical
trials
Copyright © 2010-2024, PeerVoice
CCA and Patients’ Challenges h Treatments
Limited
therapeutic
options
Delays in
molecular
testing
Limited
access to
innovative
treatments
Surgery
Courtesy of Elisabeth Baucolls
Limited
access to
clinical
trials
Copyright © 2010-2024, PeerVoice
PeerVoice
Bal hope ab)
& Compassionate ‚communication
Comprehensive support systems &
(&) Coping strategies
Fostering resilience Qa
Courtesy of Elisabeth Baucells.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Bal hope ab)
& Compassionate ‚communication
Comprehensive support systems &
(&) Coping strategies
Fostering resilience Qa
Courtesy of Elisabeth Baucells.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
Why Connecting Patients With Patient Organisations Matters
“Nearly eight years ago, | left the hospital Emotional
unsteady on my feet, unable to process support
the diagnosis | had just received. After
three months of hospitalisation and Support for Reliable
several surgeries, my chances of survival caregivers information
were minimal. | didn't know anyone with
the same diagnosis. However, the care CCA
and love from my family and friends gave patient organisations
me the strength to fight for my life. With and support groups
ATUVIBI, hope and confidence are a relief,
and treatments continue progressing.” powermen: Shared
and hope experiences
Meaningful
ae connections
Courtesy of Elisabeth Baucolls
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Why Connecting Patients With Patient Organisations Matters
“Nearly eight years ago, | left the hospital Emotional
unsteady on my feet, unable to process support
the diagnosis | had just received. After
three months of hospitalisation and Support for Reliable
several surgeries, my chances of survival caregivers information
were minimal. | didn't know anyone with
the same diagnosis. However, the care CCA
and love from my family and friends gave patient organisations
me the strength to fight for my life. With and support groups
ATUVIBI, hope and confidence are a relief,
and treatments continue progressing.” powermen: Shared
and hope experiences
Meaningful
ae connections
Courtesy of Elisabeth Baucolls
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
Working Together for a Better Future for Patients With CCA
(E) Y ey
Courtesy of Elisabeth Baucells.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Working Together for a Better Future for Patients With CCA
(E) Y ey
Courtesy of Elisabeth Baucells.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
Part 2 of 2: Patient-Centred Care for Cholangiocarcinoma at
Each Step of the Journey
David Malka, MD, PhD
Head of Medical Oncology
Institute Mutualiste Montsouris
Paris, France
Anna Saborowski, MD, PD
Clinician Scientist
Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology
Hannover Medical School
Hannover, Germany
Elisabeth Baucells
Board Member
ATUVIBI
Madrid, Spain
Copyright © 2010-2024, PeerVoice
Part 2 of 2: Patient-Centred Care for Cholangiocarcinoma at
Each Step of the Journey
David Malka, MD, PhD
Head of Medical Oncology
Institute Mutualiste Montsouris
Paris, France
Anna Saborowski, MD, PD
Clinician Scientist
Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology
Hannover Medical School
Hannover, Germany
Elisabeth Baucells
Board Member
ATUVIBI
Madrid, Spain
Copyright © 2010-2024, PeerVoice
PeerVoice
Disclosures
David Malka, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for AbbVie Inc. (relationship ended); Amgen Inc; F. Hoffmann-La Roche Ltd. Foundation Medicine, Inc;
LEO Pharma A/S; Sanofi (relationship ended); Veracyte, Inc. (relationship ended); and Viatris Inc. (relationship
ended).
Advisory Board for AstraZeneca; Bayer AG; Bristol Myers Squibb Company; Incyte; Merck KGaA; Merck Sharp &
| Dohme Corp; Pierre Fabre Group; Servier SAS; and Taiho Oncology, Inc.
Other Financial or Material Support in the form of travel expenses for medical meetings from Amgen Inc; Bayer
AG: Bristol Myers Squibb Company; F. Hoffmann-La Roche Ltd, Merck KGaA; Merck Sharp 8: Dohme Corp; Pierre
Fabre Group; Sanofi (relationship ended); Servier SAS; and Viatris Inc. (relationship ended).
Anna Saborowski, MD, PD, has a financial interest/relationship or affiliation in the form of:
Honoraria from lecture work with AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd; Eli Lily and
‘Company; F. Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc; Merck Sharp 8: Dohme Corp; and Servier
SAS.
Advisory Board or Panel for Eisai Co, Lt
F. Hoffmann-La Roche Ltd; Incyte; and Merck Sharp & Dohme Corp.
Elisabeth Baucells has a financial interest/relationship or aff
Consultancy Fees from Curium and Sequentia Biotech SL.
on in the form of:
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Disclosures
David Malka, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for AbbVie Inc. (relationship ended); Amgen Inc; F. Hoffmann-La Roche Ltd. Foundation Medicine, Inc;
LEO Pharma A/S; Sanofi (relationship ended); Veracyte, Inc. (relationship ended); and Viatris Inc. (relationship
ended).
Advisory Board for AstraZeneca; Bayer AG; Bristol Myers Squibb Company; Incyte; Merck KGaA; Merck Sharp &
| Dohme Corp; Pierre Fabre Group; Servier SAS; and Taiho Oncology, Inc.
Other Financial or Material Support in the form of travel expenses for medical meetings from Amgen Inc; Bayer
AG: Bristol Myers Squibb Company; F. Hoffmann-La Roche Ltd, Merck KGaA; Merck Sharp 8: Dohme Corp; Pierre
Fabre Group; Sanofi (relationship ended); Servier SAS; and Viatris Inc. (relationship ended).
Anna Saborowski, MD, PD, has a financial interest/relationship or affiliation in the form of:
Honoraria from lecture work with AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd; Eli Lily and
‘Company; F. Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc; Merck Sharp 8: Dohme Corp; and Servier
SAS.
Advisory Board or Panel for Eisai Co, Lt
F. Hoffmann-La Roche Ltd; Incyte; and Merck Sharp & Dohme Corp.
Elisabeth Baucells has a financial interest/relationship or aff
Consultancy Fees from Curium and Sequentia Biotech SL.
on in the form of:
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
CCA: A Cancer Rich in Molecular Alterations
ESCAT Alterations
Extrahepatic (n = 69) Genes M Intrahepatic (n = 258)
49% DHmut D 231%
125% MIN ARIDAJA mut DS 18.1%
SC CAP! mut SN 125%
SE «45m 15%
18% M FGFR2fus DIN 8.0%
46% MÍ PIKSCA mut
0%] IDH2 mut
95% MN BRAF mut
63% MN BRCA2 mut
19% METamp
83% MSI
61% M R852 amp
0%| BRCAT mut
49% MM R682 mut
: 905
CA
CT
m2
Bx
max
Biss
105%
104%
40% 30% 20%
Prevalence, %
10% 0%
ESCAT: European Society for Medical Oncology (ESMO) Scale for Clinical Actionat
0%
10% 20% 30%
Prevalence, %
40%
ity of molecular Targets; MSI: microsat
instability.
Courtesy of Anna Saborowski, MD, PD (modified from Lamarca A et al J Hepatol. 2020;73:170-185. Kendre G et al. J Hepatol. 202378:614-626).
Verdaguer H et al. Clin Cancer Res. 2022:28:1662-1671.
www.peervoice.com/XCA870
Copyright © 2010-2024, PeerVoice
CCA: A Cancer Rich in Molecular Alterations
ESCAT Alterations
Extrahepatic (n = 69) Genes M Intrahepatic (n = 258)
49% DHmut D 231%
125% MIN ARIDAJA mut DS 18.1%
SC CAP! mut SN 125%
SE «45m 15%
18% M FGFR2fus DIN 8.0%
46% MÍ PIKSCA mut
0%] IDH2 mut
95% MN BRAF mut
63% MN BRCA2 mut
19% METamp
83% MSI
61% M R852 amp
0%| BRCAT mut
49% MM R682 mut
: 905
CA
CT
m2
Bx
max
Biss
105%
104%
40% 30% 20%
Prevalence, %
10% 0%
ESCAT: European Society for Medical Oncology (ESMO) Scale for Clinical Actionat
0%
10% 20% 30%
Prevalence, %
40%
ity of molecular Targets; MSI: microsat
instability.
Courtesy of Anna Saborowski, MD, PD (modified from Lamarca A et al J Hepatol. 2020;73:170-185. Kendre G et al. J Hepatol. 202378:614-626).
Verdaguer H et al. Clin Cancer Res. 2022:28:1662-1671.
www.peervoice.com/XCA870
Copyright © 2010-2024, PeerVoice
PeerVoice
ESCAT: Level I and Il Genomic Alterations for CCA
CCA Genomic
Alterations
Tumour-Agnostic
Genomic Alterations
Mutations BRABRICCA a
Fusions S%-IBKICCA 8
Anti-HER2 monoclonal antibodies
Anti-HER2 ADCs
Amplíications 10%-20% dCCA POCA, GBC 8 ME 40M
HERZ Ts
Anti-HERZ monoclonal antibodies
Mutations 3K-5% 18 es
Mutations (p.V600E) 50% 8 BRAF inhibitors + MEK inhibitors
Mutations (p.G12C) ax 3 KASS Ths
5 B0X-90% secretory breast cancer Es
Fons 15%-20% Spitzoid melanoma e TRKinhibitors
15%-20% endometrial cancer ict
MSLHIGMMR gq omg mosnocarcioma © PD-I checkpointinhibitors
5 7% thyroid popilary cancer me
id 2% salivary gland concer e Lis
40%-45% melanoma
Mutations (p.V6008) 5%-6% smal intestinal [3 BRAF inhibitors + MEK inhibitors
‘adenocarcinoma
20%-40% bladder cancer
Fusions 3% glioblastoma multiforme
Mutations 10%-20% urothelial carcinoma La nel
10% endometrial concer
TMB-H A [3 PD-UPD-LI checkpointinhibitors
40% small-celllung cancer
ADC: antibody-drug conjugate; dMMR: defi
programmed death
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nt DNA mismatch
i: GBC: gal bladder carcinoma: MSI-H MS
nd Y TKE tyrosine kinase inhibitor, TMB-H: tumour burden-high; TRK: tropomyosin receptor kinase.
Mosele MF etal. Ann Oncol 2024 May 27 [Epub ahead of print] doi: 101016/jannonc 2024.04 005
hy PD-t: programmed cell death protein 1. PD-Lt
Copyright © 2010-2024, PeerVoice
ESCAT: Level I and Il Genomic Alterations for CCA
CCA Genomic
Alterations
Tumour-Agnostic
Genomic Alterations
Mutations BRABRICCA a
Fusions S%-IBKICCA 8
Anti-HER2 monoclonal antibodies
Anti-HER2 ADCs
Amplíications 10%-20% dCCA POCA, GBC 8 ME 40M
HERZ Ts
Anti-HERZ monoclonal antibodies
Mutations 3K-5% 18 es
Mutations (p.V600E) 50% 8 BRAF inhibitors + MEK inhibitors
Mutations (p.G12C) ax 3 KASS Ths
5 B0X-90% secretory breast cancer Es
Fons 15%-20% Spitzoid melanoma e TRKinhibitors
15%-20% endometrial cancer ict
MSLHIGMMR gq omg mosnocarcioma © PD-I checkpointinhibitors
5 7% thyroid popilary cancer me
id 2% salivary gland concer e Lis
40%-45% melanoma
Mutations (p.V6008) 5%-6% smal intestinal [3 BRAF inhibitors + MEK inhibitors
‘adenocarcinoma
20%-40% bladder cancer
Fusions 3% glioblastoma multiforme
Mutations 10%-20% urothelial carcinoma La nel
10% endometrial concer
TMB-H A [3 PD-UPD-LI checkpointinhibitors
40% small-celllung cancer
ADC: antibody-drug conjugate; dMMR: defi
programmed death
www.peervoice.com/XCA870
nt DNA mismatch
i: GBC: gal bladder carcinoma: MSI-H MS
nd Y TKE tyrosine kinase inhibitor, TMB-H: tumour burden-high; TRK: tropomyosin receptor kinase.
Mosele MF etal. Ann Oncol 2024 May 27 [Epub ahead of print] doi: 101016/jannonc 2024.04 005
hy PD-t: programmed cell death protein 1. PD-Lt
Copyright © 2010-2024, PeerVoice
PeerVoice
Available Therapies for CCA Molecular Alterations
M
mon [FGFRZ fusion | Gens, | NTRK fusion | MSI-H/dMMR | HER2ineu | RETfusion
ne
dgotinl | Larotrectinio eruxtecan
ee || Oabrafenib- || Entrectini |] Pembrolizumab || "astuzumep- || selpercatinib
Zanidatamab
among others
FDA- Y
approved
EMA-
approved LA v _ v v = Y
*Repotrectinib is currently only FDA-approved. *T-DXd (trastuzumab deruxtecan) is currently the only approved targeted therapy for HER2.
"osidenio EMA authorisation Published 12 May, 2023. Updated 15 January, 2024, Accessed 20 June, 2024, Pemigatinib EMA authorisation Published 4 May, 2021 Updated 12 August,
2023. Accessed 20 Juno, 2024, Eutibatnib, EMA authorisation Published 18 July, 2023. Updated 19 October, 2023. Accessed 20 June, 2024. Larotrecini, EMA authorisation Published
24 October, 2018 Updated 22 August, 2023. Accessed 20 June, 2024 Entrectinib, EMA authorization Published 15 May 2023, Updated 16 May, 2023. Accessed 20 June, 2024
Pambrolzumab, EMA authorisation Published 30 Jul, 2015. Updated IS May, 2024. Accessed 20 June, 2024 in, EMA ton Published 23 April 2021 Updated 28 May,
2024. Accessed 20 June, 2024,
www.peervoice.com/XCA870
Copyright © 2010-2024, PeerVoice
Available Therapies for CCA Molecular Alterations
M
mon [FGFRZ fusion | Gens, | NTRK fusion | MSI-H/dMMR | HER2ineu | RETfusion
ne
dgotinl | Larotrectinio eruxtecan
ee || Oabrafenib- || Entrectini |] Pembrolizumab || "astuzumep- || selpercatinib
Zanidatamab
among others
FDA- Y
approved
EMA-
approved LA v _ v v = Y
*Repotrectinib is currently only FDA-approved. *T-DXd (trastuzumab deruxtecan) is currently the only approved targeted therapy for HER2.
"osidenio EMA authorisation Published 12 May, 2023. Updated 15 January, 2024, Accessed 20 June, 2024, Pemigatinib EMA authorisation Published 4 May, 2021 Updated 12 August,
2023. Accessed 20 Juno, 2024, Eutibatnib, EMA authorisation Published 18 July, 2023. Updated 19 October, 2023. Accessed 20 June, 2024. Larotrecini, EMA authorisation Published
24 October, 2018 Updated 22 August, 2023. Accessed 20 June, 2024 Entrectinib, EMA authorization Published 15 May 2023, Updated 16 May, 2023. Accessed 20 June, 2024
Pambrolzumab, EMA authorisation Published 30 Jul, 2015. Updated IS May, 2024. Accessed 20 June, 2024 in, EMA ton Published 23 April 2021 Updated 28 May,
2024. Accessed 20 June, 2024,
www.peervoice.com/XCA870
Copyright © 2010-2024, PeerVoice
PeerVoice
Improved CCA Outcomes Associated With Targeted Therapies
Vall d'Hebron Hospital Gustave Roussy Hospital
(Barcelona, Spain) (Villejuif, France)
Actionable molecular
100 sate
alterations in 56.3% 100
of patients® (184/327) A
Actionable molecular
alterations in 46.6% of
patients? (146/313)
0.75
3 0.75
3 oe 0.50
a
5 025 0.25
°
0.00 0.00 n=17
O 6 1 18 24 30 36 o 12 24 36 48 60
Time, mo
Time, mo
I ESCATI-IV alterations who did not [Y No ESCAT alterations found
M ESCAT I-IV alterations who
have access to targeted therapies
received targeted therapies
Patients with ICCA or eCCA. Patients with ICCA, eCCA, or GBC.
OS: overal survival
Antoun L et al. Ann Oncol. 2023:34(suppl 1}:5163. doi: https://doiorg/10.1016/jannone.2023.04.476. Verdaguer H et al. Clin Cancer Res. 2022:28:1662-1671.
Copyright © 2010-2024, PeerVoice
www.peervoice.com/XCA870
Improved CCA Outcomes Associated With Targeted Therapies
Vall d'Hebron Hospital Gustave Roussy Hospital
(Barcelona, Spain) (Villejuif, France)
Actionable molecular
100 sate
alterations in 56.3% 100
of patients® (184/327) A
Actionable molecular
alterations in 46.6% of
patients? (146/313)
0.75
3 0.75
3 oe 0.50
a
5 025 0.25
°
0.00 0.00 n=17
O 6 1 18 24 30 36 o 12 24 36 48 60
Time, mo
Time, mo
I ESCATI-IV alterations who did not [Y No ESCAT alterations found
M ESCAT I-IV alterations who
have access to targeted therapies
received targeted therapies
Patients with ICCA or eCCA. Patients with ICCA, eCCA, or GBC.
OS: overal survival
Antoun L et al. Ann Oncol. 2023:34(suppl 1}:5163. doi: https://doiorg/10.1016/jannone.2023.04.476. Verdaguer H et al. Clin Cancer Res. 2022:28:1662-1671.
Copyright © 2010-2024, PeerVoice
www.peervoice.com/XCA870
PeerVoice
Importance and Rationale of Early Testing in CCA
Molecula ers occur early and they do not usually change
Results should be ready at time of disease progression in order to
treat patients as soon as possible
Early testing allows for planning and prioritisation of treatment
strategies, including enrolment in clinical trials
Cho MT et al. Cancers (Basel). 2022:14:392. van de Haar J et al. Nat Med. 202127:1553-1563.
www.peervoice.com/XCA870 Copyright © 2010-2024, Peervoice
Importance and Rationale of Early Testing in CCA
Molecula ers occur early and they do not usually change
Results should be ready at time of disease progression in order to
treat patients as soon as possible
Early testing allows for planning and prioritisation of treatment
strategies, including enrolment in clinical trials
Cho MT et al. Cancers (Basel). 2022:14:392. van de Haar J et al. Nat Med. 202127:1553-1563.
www.peervoice.com/XCA870 Copyright © 2010-2024, Peervoice
PeerVoice
Types of Molecular Alterations in CCA
Single-Nucleotide Variants Insertions and Deletions Copy Number Alterations
sales, | amabas |
FB IDH missense mutations
[rar missense mutations | | A
Chromosomal Rearrangement/Fusion Identification of DNA Mismatch Error
— AJAJAJA)
y SNe MSH6/\ MLHI__ PMS2
MMR-d
- 7 Dysfunction/unstable/degra:
— = Formation of MSI
FOR fusiona Hgnamesnt mutation fequorey micros
NTRK fusions 5 zx, 7
Bekai-Saab TS et al Ann Oncol. 2021321M-1126.
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Types of Molecular Alterations in CCA
Single-Nucleotide Variants Insertions and Deletions Copy Number Alterations
sales, | amabas |
FB IDH missense mutations
[rar missense mutations | | A
Chromosomal Rearrangement/Fusion Identification of DNA Mismatch Error
— AJAJAJA)
y SNe MSH6/\ MLHI__ PMS2
MMR-d
- 7 Dysfunction/unstable/degra:
— = Formation of MSI
FOR fusiona Hgnamesnt mutation fequorey micros
NTRK fusions 5 zx, 7
Bekai-Saab TS et al Ann Oncol. 2021321M-1126.
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PeerVoice
Actionable Altera
Molecular Alteration Preferred Detection Method(s)
IDHI mutations DNA-based NGS
FGFR2 fusions RNA-based NGS
NTRK fusions RNA-based NGS
IHC
MSI-H/dMMR PCR-based techniques
DNA-based NGS
BRAF mutations DNA-based NGS
IHC + ISH
HER2 amplification DNA-based NGS
IHC: immunohistochemistry; ISH: in situ hybridisation: NGS: next-generation sequencing: PCR: polymerase chain reaction.
Bekaii-Saab TS et al Ann Oncol. 202132:1M-126.
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Copyright © 2010-2024, PeerVoice
Actionable Altera
Molecular Alteration Preferred Detection Method(s)
IDHI mutations DNA-based NGS
FGFR2 fusions RNA-based NGS
NTRK fusions RNA-based NGS
IHC
MSI-H/dMMR PCR-based techniques
DNA-based NGS
BRAF mutations DNA-based NGS
IHC + ISH
HER2 amplification DNA-based NGS
IHC: immunohistochemistry; ISH: in situ hybridisation: NGS: next-generation sequencing: PCR: polymerase chain reaction.
Bekaii-Saab TS et al Ann Oncol. 202132:1M-126.
www.peervoice.com/XCA870
Copyright © 2010-2024, PeerVoice
PeerVoice
Current Role of Liquid Biopsy for CCA
ESMO General Recommendations
+ Tissue-based testing remains the preferred test for many
cancer patients, due to limitations of ctDNA assays detecting
fusion events and copy number changes
+ ctDNA assays may be routinely used when faster results will be
clinically important, or when tissue biopsies are not possible or
inappropriate
DNA: circulating tumour-derived DNA.
Pascual J et al. Ann Oncol. 2022:33:750-768.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Current Role of Liquid Biopsy for CCA
ESMO General Recommendations
+ Tissue-based testing remains the preferred test for many
cancer patients, due to limitations of ctDNA assays detecting
fusion events and copy number changes
+ ctDNA assays may be routinely used when faster results will be
clinically important, or when tissue biopsies are not possible or
inappropriate
DNA: circulating tumour-derived DNA.
Pascual J et al. Ann Oncol. 2022:33:750-768.
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PeerVoice
Evolving Therapeutic Landscape of CCA in Europe
Pembrolizumab
+ GemCis
KEYNOTE-966
STARTRK-1 Durvalumab
Capecitabine | srarrt2 | Pembrolizumab | +Gemcis |} Futibatinib
ps ALKA-372-001 KEYNOTE-15 TOPAZ-1 PERIS
Larotrectinib migatinib Ivosidenib
LOXO-TRK-14001 FIGHT-20: ClariDHy
SCOUT.
NAVIGATE
@
Selpercatinib
UBRETTO-001
Unless otherwise indicated, the year indicates European Medicines Agency approval.
* Standard of care, although it has not received formal EMA approval
Valle J; ABC-02 Trial investigators. N Engl J Med. 2010;362:1273-1281. Primrose JN; BILCAP study group. Lancet Oncol. 2019;20:663-673. Hong DS et al Lancet
Oncol 2020:21531-540. Doebele RC et al Lancet Oncol. 2020;21271-282. Marabelle A et al.) Clin Oncol. 2020:381-10. Abou-Alta GK et al. Lancet Oncol.
2020/21671-684. Oh DY; TOPAZ-1 Investigators. NEJM evidence. 2022:1£VID0a2200015. Abou-Alfa GK et al. Lancet Oncol. 2020;21796-807. Goyal Let al. N Engl J
Med. 2023:388.228-239. Kelley RK et al KEYNOTE-966 Investigators. Lancet. 2023;4011853-I865. Subbiah V et al Lancet Oncol. 2022:23:1261-1273.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Evolving Therapeutic Landscape of CCA in Europe
Pembrolizumab
+ GemCis
KEYNOTE-966
STARTRK-1 Durvalumab
Capecitabine | srarrt2 | Pembrolizumab | +Gemcis |} Futibatinib
ps ALKA-372-001 KEYNOTE-15 TOPAZ-1 PERIS
Larotrectinib migatinib Ivosidenib
LOXO-TRK-14001 FIGHT-20: ClariDHy
SCOUT.
NAVIGATE
@
Selpercatinib
UBRETTO-001
Unless otherwise indicated, the year indicates European Medicines Agency approval.
* Standard of care, although it has not received formal EMA approval
Valle J; ABC-02 Trial investigators. N Engl J Med. 2010;362:1273-1281. Primrose JN; BILCAP study group. Lancet Oncol. 2019;20:663-673. Hong DS et al Lancet
Oncol 2020:21531-540. Doebele RC et al Lancet Oncol. 2020;21271-282. Marabelle A et al.) Clin Oncol. 2020:381-10. Abou-Alta GK et al. Lancet Oncol.
2020/21671-684. Oh DY; TOPAZ-1 Investigators. NEJM evidence. 2022:1£VID0a2200015. Abou-Alfa GK et al. Lancet Oncol. 2020;21796-807. Goyal Let al. N Engl J
Med. 2023:388.228-239. Kelley RK et al KEYNOTE-966 Investigators. Lancet. 2023;4011853-I865. Subbiah V et al Lancet Oncol. 2022:23:1261-1273.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
ESMO Guidelines for the Treatment of CCA
CCA
Advanced or metastatic
Molecular profiling
GemCis + durvalumab
Locally advanced
Early stage
GemCis +
durvalumab
Adjuvant
capecitabine
Surveillance
Current ESMO guidelines for the treatment of CCA are under review and updates are expected in the near future.
S-FU: fluorouracil: FOLFOX: folinic acid, fluorouracil oxaliplatin; GemCis: gemcitabine + cisplatin.
Vogel A etal. Ann Oncol. 2023;34:127-140,
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
ESMO Guidelines for the Treatment of CCA
CCA
Advanced or metastatic
Molecular profiling
GemCis + durvalumab
Locally advanced
Early stage
GemCis +
durvalumab
Adjuvant
capecitabine
Surveillance
Current ESMO guidelines for the treatment of CCA are under review and updates are expected in the near future.
S-FU: fluorouracil: FOLFOX: folinic acid, fluorouracil oxaliplatin; GemCis: gemcitabine + cisplatin.
Vogel A etal. Ann Oncol. 2023;34:127-140,
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
Courtesy of Anna Saborowski, MD, PD, and David Malka, MD, PhD.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Courtesy of Anna Saborowski, MD, PD, and David Malka, MD, PhD.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
Is Treatment Se: ncing Possible in CCA?
A 48-year-old woman with FGFR2 fusion
treated at the MHH, Hannover, Germany
Gatekeeper Molecular Brake
VS6SF VS6SI NSSOK NSSOH ESGGA K642R
Pemigatinib M4 Futibatinib 0 4
N550K N550D
j PR o) f
PR PR
24 months | 1 months 4 months
Mi: Medizinische Hochschule Hannover; PR: partial response.
Courtesy of Anna Saborowski MD, PO.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
Is Treatment Se: ncing Possible in CCA?
A 48-year-old woman with FGFR2 fusion
treated at the MHH, Hannover, Germany
Gatekeeper Molecular Brake
VS6SF VS6SI NSSOK NSSOH ESGGA K642R
Pemigatinib M4 Futibatinib 0 4
N550K N550D
j PR o) f
PR PR
24 months | 1 months 4 months
Mi: Medizinische Hochschule Hannover; PR: partial response.
Courtesy of Anna Saborowski MD, PO.
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
PeerVoice
ClarlDHy: Safety Profile of lvosidenib vs Placebo
TEAES
Nausea
Diarrhoea
Fatigue
‘Abdominal pain
Cough
Decreased appetite
Ascites
Vomiting
Anaemia
Grade
Any
23
Any
23
Any
23
Any
23
Any
23
Any
23
Any
23
Any
23
Any
23
Ivosidenib, %
(N=123)
41
2
35
o
a
3
24
2
25
o
24
2
23
9
23
2
18
7
Placebo, %
(N = 59)
TEAE: treatment-emergent adverse event.
Zhu AX et al JAMA Oncol. 20217:1689-1677.
www.peervoice.com/XCA870
Copyright © 2010-2024, PeerVoice
ClarlDHy: Safety Profile of lvosidenib vs Placebo
TEAES
Nausea
Diarrhoea
Fatigue
‘Abdominal pain
Cough
Decreased appetite
Ascites
Vomiting
Anaemia
Grade
Any
23
Any
23
Any
23
Any
23
Any
23
Any
23
Any
23
Any
23
Any
23
Ivosidenib, %
(N=123)
41
2
35
o
a
3
24
2
25
o
24
2
23
9
23
2
18
7
Placebo, %
(N = 59)
TEAE: treatment-emergent adverse event.
Zhu AX et al JAMA Oncol. 20217:1689-1677.
www.peervoice.com/XCA870
Copyright © 2010-2024, PeerVoice
PeerVoice
FGFR Inhibitors: Common TEAEs
PEMI-BIL and PEMI-REAL
(n=108) Cohorts (n=72)
Hyperphosphataomia AV Ea ES En
Aopecia an a = =
Nail toxicities? a E a =
moco Ay se as 2
Foie ny ae on co
Stomatitis a a a 2
e À 2 5
ovr E 5 i
PPE syndrome a E a a
* Incidence of TEAES is only for reference purposes and not comparable between studies.
discolouration; nail disorder; nal dystrophy; onychoclasis; onycholysis; and onychomadesis.
PE: palmar-plantar erythrodysesthesia.
Goyal L et al N Eng! J Med. 2023:388:228-239. Parisi A et al Eur J Cancer. 2024;200:113587. Vogel A et al ESMO Open. 2024 4 June. [Epub ahead of print]
0i:10.1016/jesmoop 2024103488,
il toxicities include nail,
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
FGFR Inhibitors: Common TEAEs
PEMI-BIL and PEMI-REAL
(n=108) Cohorts (n=72)
Hyperphosphataomia AV Ea ES En
Aopecia an a = =
Nail toxicities? a E a =
moco Ay se as 2
Foie ny ae on co
Stomatitis a a a 2
e À 2 5
ovr E 5 i
PPE syndrome a E a a
* Incidence of TEAES is only for reference purposes and not comparable between studies.
discolouration; nail disorder; nal dystrophy; onychoclasis; onycholysis; and onychomadesis.
PE: palmar-plantar erythrodysesthesia.
Goyal L et al N Eng! J Med. 2023:388:228-239. Parisi A et al Eur J Cancer. 2024;200:113587. Vogel A et al ESMO Open. 2024 4 June. [Epub ahead of print]
0i:10.1016/jesmoop 2024103488,
il toxicities include nail,
www.peervoice.com/XCA870 Copyright © 2010-2024, PeerVoice
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