Optimising Outcomes for Our Patients With Advanced Urothelial Carcinoma: Best Practices and Future Directions in Maintenance Therapy

Thomas Powles, MBBS, MRCP, MD, discusses urothelial carcinoma in this CE activity titled "Optimising Outcomes for Our Patients With Advanced Urothelial Carcinoma: Best Practices and Future Directions in Maintenance Therapy." For the full presentation, please visit us at www.peervoice.com/NYE870.

1. PeerVoice

Optimising Outcomes for Our Patients With Advanced Urothelial
Carcinoma: Best Practices and Future Directions in Maintenance Therapy

Learning Objectives

Assess current treatment options for first-line management of advanced
urothelial carcinoma (aUC), including maintenance therapy

Identify patients with aUC who may benefit from maintenance therapy
Formulate appropriate maintenance therapy plans for patients with aUC

Identify emerging therapies, including maintenance therapies, for the
management of aUC

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Part 1 of 4: What Are Our Options? Reviewing Current Approaches in First:

ine Management of
Advanced Urothelial Carcinoma

Thomas Powles, MBBS, MRCP, MD

Professor of Genitourinary Oncology and Director of Barts Cancer Centre
Centre of Experimental Cancer Medicine, Barts Cancer Institute, Queen
Mary University London

Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom

Copyright © 2010-2024,

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Disclosures

Thomas Powles, MBBS, MRCP, MD, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc.; AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd; Exelixis,
Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc; Incyte; Ipsen Biopharmaceuticals, Inc.; Johnson &
Johnson; Mashup; Merck KGaA; Merck Sharp & Dohme Corp.; Novartis AG; Pfizer Inc.; and Seattle
Genetics, Inc.

Grant/Research Support from institutional work with Astellas Pharma Inc; AstraZeneca; Bristol Myers
Squibb Company; Eisai Co. Ltd. Exelixis, Inc.; F. Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc.;
Johnson & Johnson; Merck KGaA; Merck Sharp & Dohme Corp.; Novartis AG; Pfizer Inc.; and Seattle
Genetics, Inc.

Advisory Board for Astellas Pharma Inc; AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd;
Exelixis, Inc, F. Hoffmann-La Roche Ltd. Ipsen Biopharmaceuticals, Inc; Johnson & Johnson; Merck
KGaA; Merck Sharp & Dohme Corp; Novartis AG; Pfizer Inc.; and Seattle Genetics, Inc.

Other Financial or Material Support from travel and accommodation costs paid by AstraZeneca; F.
Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc. Merck Sharp & Dohme Corp. and Pfizer Inc.
Principal Investigator Work for AstraZeneca; Eisai Co. Ltd; F. Hoffmann-La Roche Ltd.; Genentech, Inc.;
Merck KGaA; Novartis AG; and Pfizer Inc.

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Approved First-Line Therapeutic Options for LA/mUC

Patient Group Approved Therapy Approval: FDA EMA
Cisplatin-eligible, Cisplatin-based ns
irrespective of PD-L status chemotherapy

June 2020 Jan 2021

Cisplatin-ineligible, Gem-carboplatin
irrespective of PD-L1 status chemotherapy

Cisplatin- ineligible and Atezolizumab | Withdrawn! || Sept 2017?
— PDU positive) [ Pembrolizumab_| May 20173 | July 20172

All patients, irrespective of Enfortumab
cisplatin eligibility or PD-L1 vedotin plus Dec 2023 N/A
status pembrolizumab

Cisplatin-eligible,
irrespective of PD-L1 status

March 2024 N/A

Gem-Cis followed by
nivo maintenance

| Nivolumab plus |

Approved in May 2016; licence withdrawn by company in November 2022
2Date of intial approval: indication updated in 2018
#Date of accelerated approval, replaced in May 2017 by regular approval and restricted indication

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EV-302: Outcomes

os PFS
Risk of death was reduced by 53% Risk of progression or death was reduced by 55%
in patients who received EV + P in patients who received EV + P
oo
©
80

OS, %
08388883888
PFS,%

02468011 % 5 20222426 28 3032 343638 0246800 MX 1 20 22 24 26 28 30 32 34

Time, mo Time, mo
EC A A ENT
Events, n (%) 133 (30.1) 226 (50.9) Events, n(%) 223 (505) 307 (69.1)

HR (95% CI) 0.47 (0.38-0.58) HR (95% Cl) 0.45 (0.38-0.54)
ne — OUEN —
MOS, (95% Cl), mo 315 (25.4-NR) 16.1 (13.9-18.3) mPFS, (95% Cl), mo 12.5 (10.4-16.6) 63(62-65)

Enfortumab vedotin plus pembrolizumab: FDA approved (2023) as a first-line
treatment for all patients with LA or mUC, regardless of cisplatin eligibility or PD-L1 status

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EV-302: TRAEs With Enfortumab Vedotin Plus Pembrolizumab

Overall

Peripheral sensory neuropathy
Pruritus

Alopaecia
Maculopapular rash
Fatigue

Diarrhoea
Decreased appetite
Nausea

Anaemia
Neutropaenia

‘Thrombocytopaenia

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970

EV +P (n =440)

Chemotherapy (n =433)
950

Grades 1/2 23]
Ev+P =

Chemotherapy = m

360

388

Incidence, %

Serious TRAEs
+ EV+P:122; 277%
+ Chemotherapy: 85; 19.6%

Grade 23 TRAEs:
+ EV +P: 56%
+ Chemotherapy: 70%

TRAES leading to death
(per investigator):
+ EV+P(4;0.9%)
- Asthenia
- Diarrhoea
- Immune-mediated lung
disease
— Multiple organ dysfunction
syndrome
+ Chemotherapy (4; 0.9%)
~ Febrile neutropenia
— Myocardial infarction
= Neutropenic sepsis
~ Sepsis

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CheckMate-901: Outcomes

os

PFS

Nivolumab + Gem-Cis

OS, %

0858885883888
PFS,%

05388883888

[(REFETETTETT. [(REFETETTET:

Time, mo Time, mo
Events, n (%) 172 (665) 193 (63.4) Events, n (%) 211(69.4) 191(62.8)
HR (95% Cl) 078 (0.63-0.96) HR (95% Cl) 0.72(0.59-0.88)
Pvalue =02 P value =001
MOS, (95% Cl.mo 217(186-264) 189 (147-224) mPFS, (95% Cl), mo 79 (76-95) 78(61-78)

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Abbreviations and References

Approved First-Line Therapeutic Options for LA/mUC

Abbreviation(s): EMA: European Medicines Agency; FDA: US Food and Drug Administration. LA: locally advanced;

mUC: metastatic urothelial carcinoma; PD-LI: programmed death-ligand 1.

Reference(s): US Food and Drug Administration (FDA). Avelumab: Authorisation. https://www.fda gov/drugs/drug-approvals-and-
databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment. Published 1 July, 2020. Accessed 22 April,
2024,

European Medicines Agency (EMA). Avelumab: Authorisation. https://www.ema.europa.eu/en/documents/product-
information/bavencio-epar-product-information_en.pdf. Published 13 October, 2017. Accessed 22 April, 2024.

FDA. Atezolizumab: Authorisation. Published 19 May, 2016. Accessed 22 April, 2024.

EMA Atezolizumab: Authorisation. https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product=
information_en.pdf. Published 29 August, 2017. Accessed 22 April, 2024.

Suzman DL et al. Oncologist. 2019;24:563-569.

FDA. Pembrolizumab: Authorisation. https://www.onclive.com/view/fda-grants-full-approval-to-pembrolizumab-for-select-
locally-advanced-or-metastatic-urothelial-cancer. 31 August 2021 Accessed 22 April, 2024.

EMA. EMA restricts use of atezolizumab and pembrolizumab in bladder cancer. https://www.ema.europa.eu/en/news/ema-
restricts-use-keytruda-tecentriq-bladder-cancer. Published 1 June, 2018. Accessed 22 April, 2024.

FDA. Enfortumab vedotin with pembrolizumab: Authorisation. https://www.fda.gov/drugs/resources-information-approved-
drugs/fda-approves-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic-urothelial-cancer. Published 15
December, 2023. Accessed Il April, 2024.

FDA. Nivolumab in combination with cisplatin and gemcitabine: Authorisation. https://www.fda.gov/drugs/resources-information-
approved-drugs/fda-approves-nivolumab-combination-cisplatin-and-gemcitabine-unresectable-or-metastatic-urothelial.
Published 7 March, 2024. Accessed 11 April, 2024.

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Abbreviations and References (Cont'd)

EV-302: Outcomes

Abbreviation(s): Cl: confidence interval; EV: enfortumab vedotin; HR: hazard ratio; mo: month; mOS: median overall
survival; mPFS: median progression-free survival; P: pembrolizumab.

Reference(s): Powles et al. European Society for Medical Oncology (ESMO) Congress. 2023. Abstract LBAG.

FDA. Enfortumab vedotin with pembrolizumab: Authorisation. https://www.fda.gov/drugs/resources-information-
approved-drugs/fda-approves-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic=
urothelial-cancer. Published 15 December, 2023. Accessed 11 April, 2024.

EV-302: TRAEs With Enfortumab Vedotin Plus Pembrolizumab

Abbreviation(s): TRAE: treatment-related adverse event.
Reference(s): Powles T et al. European Society for Medical Oncology (ESMO) Congress. 2023. Abstract LBAG.

CheckMate-901: Outcomes

Abbreviation(s): Gem-Cis: gemcitabine cisplatin.
Reference(s): van der Heijden MS et al; CheckMate 901 Trial Investigators. N Engl J Med. 2023;389:1778-1789.

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Part 2 of 4: Who May Benefit From Maintenance Therapy? Identifying Eligible Patients

Thomas Powles, MBBS, MRCP, MD

Professor of Genitourinary Oncology and Director of Barts Cancer Centre
Centre of Experimental Cancer Medicine, Barts Cancer Institute, Queen
Mary University London

Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom

Copyright © 2010-2024, PeerVoice

11. PeerVoice

Disclosures

Thomas Powles, MBBS, MRCP, MD, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc.; AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd; Exelixis,
Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc; Incyte; Ipsen Biopharmaceuticals, Inc.; Johnson &
Johnson; Mashup; Merck KGaA; Merck Sharp & Dohme Corp.; Novartis AG; Pfizer Inc.; and Seattle
Genetics, Inc.

Grant/Research Support from institutional work with Astellas Pharma Inc; AstraZeneca; Bristol Myers
Squibb Company; Eisai Co. Ltd. Exelixis, Inc.; F. Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc.;
Johnson & Johnson; Merck KGaA; Merck Sharp & Dohme Corp.; Novartis AG; Pfizer Inc.; and Seattle
Genetics, Inc.

Advisory Board for Astellas Pharma Inc; AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd;
Exelixis, Inc, F. Hoffmann-La Roche Ltd. Ipsen Biopharmaceuticals, Inc; Johnson & Johnson; Merck
KGaA; Merck Sharp & Dohme Corp; Novartis AG; Pfizer Inc.; and Seattle Genetics, Inc.

Other Financial or Material Support from travel and accommodation costs paid by AstraZeneca; F.
Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc. Merck Sharp & Dohme Corp. and Pfizer Inc.
Principal Investigator Work for AstraZeneca; Eisai Co. Ltd; F. Hoffmann-La Roche Ltd.; Genentech, Inc.;
Merck KGaA; Novartis AG; and Pfizer Inc.

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JAVELIN Bladder 100: Long-Term Outcomes

5 os a PFS
: :
E :
LE. ok avelumab+esc Edo
: :
o o +
Time, mo Time, mo
a A 2
(n= 350) (n= 350) (n= 350) (n = 350)
Events, n (%) 215 (614) 237 (67.7) Events, n (%) 268 (76.6) 287 (82.0)
OS, median (95% CI), mo 23.8 (19.9-28.8) 15.0 (13.5-18.2) PFS, median (95% Cl), mo 55 (4.2-7.2) 21(19-30)
‘Stratified HR (95% CI) 0.76 (0.63-0.91) Stratified HR (95% Cl) 0.54 (0.46-0.64)

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Real-World Outcomes With Avelumab Mainte e

Patients, n an 595 214 160

7 70 73 70
Age, y (range) (49-84) (63-76) (67-78) 2, (40-90)
Median follow 203 16
up, mo (range) (19.8-20.9) 263 El (1-21)
MOS, mo (range) RE 26.2 213 23.8 24.4
(95% Cl)! (20.0-NE) (17.6-24.6) (18.2-NE) (20.4-28.4)

"From the start of avelumab maintenance

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Defining Platinum Eligibility Criteria for LA/mUC

Recommended Criteria for Pt Eligibility
(Based on a survey of 60 genitourinary

oncologists from the USA)

Survey Results for European-Based
Oncologists / Urologists (N = 503)

for Pt
Threshold 575 241
Age, years >80 332
ad 22 40.6
ze ECOG PS = ee
EE <25 286
PN grade 22 <30 34.8
Ara DB 443
NYHA HF class a grade 23 417
rel! (ECOG PS 2) <30 NYHA HF class D 2
cami Crcie <40 22.7
(ECOG PS 2) <30 32.2
CrCl for Cis <40 223
ineligibility <50 34.4

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Abbreviations and References

JAVELIN Bladder 100: Long-Term Outcomes

Abbreviation(s): BSC: best supportive care; Cl: confidence interval; HR: hazard ratio; mo: month; OS: overall survival;
PFS: progression-free survival.

Reference(s): Powles T et al. J Clin Oncol. 2023;413486-3492.

Real-World Outcomes With Avelumab Maintenance

4Abbreviation(s): mOS: median overall survival; NE: not evaluable; NR: not reached.

Reference(s): American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium 2024: Press
Release. https://www.merckgroup.com/content/dam/web/corporate/non-images/press-releases/2024/jan/en/ASCO-
GU-2024-Press-Release-ENpdf. Published January, 2024. Accessed 22 April, 2024.

Defining Platinum Eligibility Criteria for LA/mUC

Abbreviation(s): Cis: cisplatin; CrCl: creatinine clearance; ECOG PS: Eastern Cooperative Oncology Group Performance
Status; HF: heart failure; LA: locally advanced; mUC: metastatic urothelial cancer; NYHA: New York Heart Association;
PN: peripheral neuropathy; Pt: platinum.

Reference(s): Gupta $ et al. ASGO GU 2024. Abstract 696. https://doi.org/10:1200/JC0.2024.42.4_suppl.696.

Gupta $ et al. ASCO 2022. Abstract 4577. https://ascopubs.org/doi/pdf/10.1200/JC0.2022.40.16_suppl4577.

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Part 3 of 4: How Should We Proceed? Best Practices in Providing Maintenance Therapy

Thomas Powles, MBBS, MRCP, MD

Professor of Genitourinary Oncology and Director of Barts Cancer Centre
Centre of Experimental Cancer Medicine, Barts Cancer Institute, Queen
Mary University London

Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom

Copyright © 2010-2024,

17. PeerVoice

Disclosures

Thomas Powles, MBBS, MRCP, MD, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc.; AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd; Exelixis,
Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc; Incyte; Ipsen Biopharmaceuticals, Inc.; Johnson &
Johnson; Mashup; Merck KGaA; Merck Sharp & Dohme Corp.; Novartis AG; Pfizer Inc.; and Seattle
Genetics, Inc.

Grant/Research Support from institutional work with Astellas Pharma Inc; AstraZeneca; Bristol Myers
Squibb Company; Eisai Co. Ltd. Exelixis, Inc.; F. Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc.;
Johnson & Johnson; Merck KGaA; Merck Sharp & Dohme Corp.; Novartis AG; Pfizer Inc.; and Seattle
Genetics, Inc.

Advisory Board for Astellas Pharma Inc; AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd;
Exelixis, Inc, F. Hoffmann-La Roche Ltd. Ipsen Biopharmaceuticals, Inc; Johnson & Johnson; Merck
KGaA; Merck Sharp & Dohme Corp; Novartis AG; Pfizer Inc.; and Seattle Genetics, Inc.

Other Financial or Material Support from travel and accommodation costs paid by AstraZeneca; F.
Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc. Merck Sharp & Dohme Corp. and Pfizer Inc.
Principal Investigator Work for AstraZeneca; Eisai Co. Ltd; F. Hoffmann-La Roche Ltd.; Genentech, Inc.;
Merck KGaA; Novartis AG; and Pfizer Inc.

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JAVELIN Bladder 100: AEs With Avelumab Maintenance

Event, n (%)

Any AE

Fatigue

Pruritus

Urinary tract infection
Diarrhoea

Arthralgia

Asthenia
Constipation

Back pain

Nausea

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Avelumab (n = 334)
Any Grade

337 (98.0)
61 (17.7)
59 (17.2)
59 (17.2)
57 (16.6)
56 (16.3)
56 (16.3)
56 (16.3)
55 (16.0)
54 (15.7)

163 (47.4)
6 (17)
1(0.3)

15 (4.4)
2(06)
2(06)
(o)
2(0.6)
4(1.2)
1(0.3)

268 (77.7)
24 (7.0)
6 (17)
36 (10.4)
17 (4.9)
19 (5.5)
19 (5.5)
31(9.0)
34 (9.9)
22 (6.4)

87 (25.2)
2 (06)
o
9 (2.6)
1(0.3)
o
4 (12)
(o)

8 (2.3)
2(0.6)

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Abbreviations and References

JAVELIN Bladder 100: AEs With Avelumab Maintenance

Abbreviation(s): AE: adverse event.
Reference(s): Powles T et al. N Engl J Med. 2020;383:1218-1230.

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Part 4 of 4: Where Are We Going? Possible Future Directions and Combination Approaches in Maintenance Therapy

Thomas Powles, MBBS, MRCP, MD

Professor of Genitourinary Oncology and Director of Barts Cancer Centre
Centre of Experimental Cancer Medicine, Barts Cancer Institute, Queen
Mary University London

Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom

Copyright © 2010-2024,

21. PeerVoice

Disclosures

Thomas Powles, MBBS, MRCP, MD, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc.; AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd; Exelixis,
Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc; Incyte; Ipsen Biopharmaceuticals, Inc.; Johnson &
Johnson; Mashup; Merck KGaA; Merck Sharp & Dohme Corp.; Novartis AG; Pfizer Inc.; and Seattle
Genetics, Inc.

Grant/Research Support from institutional work with Astellas Pharma Inc; AstraZeneca; Bristol Myers
Squibb Company; Eisai Co. Ltd. Exelixis, Inc.; F. Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc.;
Johnson & Johnson; Merck KGaA; Merck Sharp & Dohme Corp.; Novartis AG; Pfizer Inc.; and Seattle
Genetics, Inc.

Advisory Board for Astellas Pharma Inc; AstraZeneca; Bristol Myers Squibb Company; Eisai Co, Ltd;
Exelixis, Inc, F. Hoffmann-La Roche Ltd. Ipsen Biopharmaceuticals, Inc; Johnson & Johnson; Merck
KGaA; Merck Sharp & Dohme Corp; Novartis AG; Pfizer Inc.; and Seattle Genetics, Inc.

Other Financial or Material Support from travel and accommodation costs paid by AstraZeneca; F.
Hoffmann-La Roche Ltd; Ipsen Biopharmaceuticals, Inc. Merck Sharp & Dohme Corp. and Pfizer Inc.
Principal Investigator Work for AstraZeneca; Eisai Co. Ltd; F. Hoffmann-La Roche Ltd.; Genentech, Inc.;
Merck KGaA; Novartis AG; and Pfizer Inc.

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First-Line Investigational Therapies for LA/mUC

Trial Study Ty;

Maintenance treatment with:
JAVELIN Bladder Phase 2 + Avelumab Ren
Medley Randomised + Avelumab plus SG (Glob: ‘ee an ns)
(NCTO5327530) | open-label + Avelumab plus M6223 ‚ODalllocations,
+ Avelumab plus NKTR-255
TROPHY U-O1 Phase 2 + SG plus Cis followed by maintenance with Recruit
(NCTO3547973) | Nonrandomised | avelumab plus SG vs. SG plus Cis followed | (Gobait he )
Cohort 4 (C4) open-label by maintenance with zimberelimab plus SG | ‘@!0P@! locations,
(NCTO5092958) | “Gnen-label + Avelumab plus cabozantinib (US locations)
: Recruiting
Ue pra Press + Disitamab vedotin plus pembrolizumab vs. (Australia,
FER? Randomised Gem-Cis or Gem-Carbo Canada, US
(NCTO5911295) open-label O pd
locations)

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Abbreviations and References

First-Line Investigational Therapies for LA/mUC.

Abbreviation(s): Carbo: carboplatin; cis: cisplatin; gem: gemcitabine; HER2: human epidermal growth factor receptor 2;
LA: locally advanced; mUC: metastatic urothelial carcinoma; SG: sacituzumab govitecan; UC: urothelial carcinoma.
Reference(s): NCTO3036098. https://clinicaltrials.gov/study/NCTO3036098. Accessed 22 April, 2024.

NCT05327530. https://clinicaltrials.gov/study/NCTO5327530. Accessed 10 April, 2024.

NCTO3547973. https://clinicaltrials.gov/study/NCTO3547973. Accessed 10 April, 2024.

NCT05911295. https://clinicaltrials. gov/study/NCTO5911295. Accessed 10 April, 2024.

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