Practical Considerations for ADC-ICI Combinations in Advanced Urothelial Carcinoma: Identifying and Managing Adverse Events

Andrea Necchi, MD discusses urothelial carcinoma in this [CME] activity titled "Practical Considerations for ADC-ICI Combinations in Advanced Urothelial Carcinoma: Identifying and Managing Adverse Events." For the full presentation, please visit us at www.peervoice.com/FED870.

1. PeerVoice

Practical Considerations for ADC-ICI Combinations in Advanced
Urothelial Carcinoma: Identifying and Managing Adverse Events

Learning Objectives
Identify adverse events associated with the combination of a nectin-4—directed
antibody-drug conjugate (ADC) and a PD-1 inhibitor in patients with locally
advanced urothelial carcinoma (laUC) and metastatic urothelial carcinoma (mUC)
Formulate best practice approaches to the monitoring, identification, and
management of adverse events associated with the combination of a nectin-4—
directed ADC and a PD-1 inhibitor in patients with laUC and mUC

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Part 1 of 4: Considering Individual Toxicity Profiles: ADCs and ICIs

Andrea Necchi, MD

Associate Professor

Vita-Salute San Raffaele University
Director of GU Medical Oncology
IRCCS San Raffaele Hospital

Milan, Italy

Copyright © 2010-202.

3. PeerVoice

Andrea Necchi, MD, has a financial interest/relationship or affiliation in the
form of:
Consultant for AstraZeneca; Bristol Myers Squibb Company; Catalym GmbH; F.
Hoffmann-La Roche Ltd. Gilead Sciences, Inc.; Johnson & Johnson; Merck
KGaA; Merck Sharp & Dohme Corp. Pfizer Inc.; and Seagen Inc.

@ Grant/Research Support from Bristol Myers Squibb Company; Gilead Sciences,
Inc.; Incyte; and Merck Sharp & Dohme Corp.
Advisory Board for AstraZeneca; Bristol Myers Squibb Company; Catalym
GmbH; F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Johnson & Johnson;
Merck KGaA; Merck Sharp & Dohme Corp.; Pfizer Inc.; and Seagen Inc.

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ADCs vs ICls: Distinct But Complementary MOAs

-Ant-nectin-4 monoctonlanttody
= protease-cleaabi inter
~Monomatny suitatin€ mac
people

N
1) Binds to A \
antigen 2) Complex is internalised \
and traffics to lysosome
4) Microtubule
‘Risruption
3) MMAE is =.
released + 5)Cell cycle
arrest and
apoptosis

ADC - EV

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PD-LI/PD-1 binding inhibits
T-cell kiling of tumour cell

Blocking PD-LI or PD-1
allows T-cell iling of
tumour cell

T-cell

ICls

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ADC vs ICI: Distinct Yet Overlapping AEs

ea Neurologic

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Toxicity Profile: Nivo + GemCis in Previously Untreated mUC

CheckMate 901
TRAE, %
Any

Nivo + GemCis (n = 304)
Any Gi Gra
7

GemCis (n = 288)
E

Leading to discontinuation

2

‘Anaemia
Nausea

Neutropenia

Decreased neutrophil count
Fatigue

Decreased appetite

Decreased platelet count
Decreased white blood cell count
Vomiting

Asthaenia

Thrombocytopaenia

Pruritus

Constipation

Rash

Diarrhosa

Hypothyroidism

Increased blood creatinine
Leukopenia

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E

a UE
a 30
25 a
2 2: 2
2 TE 6
2 15

Grades: 1-2 23
Nivo + GemCis = m
GemCis m m

“a
ZÉ
sjs3 535

so 4

o D 3 40 60
Incidence, %

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Toxicity Profile: Avelumab 1L Maintenance for aUC

JAVELIN Bladder 100 Trial After 22 Years of Follow-Up
Grade 23 mGrade 1-2

Any TRAE
Pruritus

Rash

Fatigue
Diarrhoea

Lipase increased

Colitis

Hypertriglyceridaemia

T
o 5 10 15 20 25 30 35 40

Most common TRAEs (>1%) occurring after 212 months Patients, %
of treatment with avelumab plus BSC (n = 118)

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Toxicity Profile: EV in Previously Treated aUC

EV-301: 24-Month Findings

EV (n= 296) CT (n = 291)
TRAE, %
Any Grade Grade 23 Any Grade Grade 23

Alopecia 456 NR 371 NR
Peripheral sensory neuropathy 348 51 216 21
Pruritus 324 14 48 03
Fatiguo 314 68 227 45
Decreased appetite EN 3.0 237 17
Diarrhoea 250 34 168 17
Dysgeusia 247 NR 76 NR
Nausea 240 10 220 14
Maculopapular rash 169 74 17 o
Anaemia 15, 27 216 79
Decreased neutrophil count 105 61 75 11
Neutropenia 68 47 86 62
Decreased white blood cell count 51 14 1.0 72
Febrile neutropenia 07 07 55 Es

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Toxicity Profile: EV + Pembro in Previously Untreated aUC

EV-302

Overall

Peripheral sensory neuropathy
Pruritus.

Alopaecia
Maculopapular rash
Fatigue

Diarrhoea
Decreased appetite
Neusea

Anaemia
Neutropenia

Thrombocytopenia

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EV + Pembro (n = 440)

970

ChT (n = 433)

Grades 12 23
EV + Pembro
cht

or
100 90 80 70 60 50 40

FT
3020 © 0 ©

Incidence, %

Serious TRAEs, %
+ EV + Pembro: 277
+ ChT:19.6

Grade 23 TRAES, %
+ EV + Pembro: 56
+ ChT:70

TRAES Leading to Death, %
(per investigator)

+ EV + Pembro (0.9)

Asthaenia

Diarrhoea
immune-mediated lung
disease

Multiple organ dysfunction
syndrome

+ ChT (0.9)

Febrile neutropenia
Myocardial infarction
Neutropenic sepsis

Sepsis

1

1

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Quality of Life in Patients With aUC Treated With First-Line EV

Alone or With Pembro

Cisplatin-Ineligible EV-103 Cohort K

EORTC QLQ-C30 QOL and functioning scales EORTC QLQ-C30* GOL and functioning scales

Adjusted LS Mean
‘Change From al

Worsening

Time, w

EORTC QLO-C3O symptom scales

EV+P Arm
EV Mono Arm

— at

Adjusted LS Mean
‘Change From BL.

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Abbreviations and References

ADCs vs ICIs: Distinct But Complementary MOAs

Abbreviation(s): ADC: antibody-drug conjugate; EV: enfortumab vedotin; ICI immune checkpoint inhibitor;
MOA: mechanism of action.

Reference(s): National Cancer Institute (NC) Staff. NCI. https://www.cancer gov/news-events/cancer-currents-
blog/2016/fda-atezolizumab -bladder. Published 7 June 2016. Accessed 23 July 2024.

NCI Staff. NCI. https:/www.cancer.gov/news-events/cancer-currents-blog/2020/enfortumab-vedotin-bladder-
cancer-fda-approval. Published 14 January 2020. Accessed 23 July 2024.

ADC vs ICI: Distinct Yet Overlapping AEs

Reference(s): Brahmer JR et al. J Immunother Cancer. 2021;9:e002435.
Schneider BJ et al. JCO Oncol Pract. 2022;18:431-444.

Wang D et al. Front Pharmacol, 2021:12:710943.

Powels T et al. N Engl J Med. 2021;384:1125-1135.

Toxicity Profile: Nivo + GemCis in Previously Untreated mUC

Abbreviation(s): GemCis: gemcitabine plus cisplatin; mUC: metastatic urothelial cancer;
Reference(s): van der Heijden MS et al. Ann Oncol. 2023;34(suppl_2):S1254-S1335.

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Abbreviations and References (Cont'd)

Toxicity Profile: Avelumab 1L Maintenance for aUC

Abbreviation(s): aUC: advanced urothelial cancer.
Reference(s): Powles T et al. J Clin Oncol. 2023;

486-3492.

Toxicity Profile: EV in Previously Treated aUC

Abbreviation(s): ChT: chemotherapy.

Reference(s): Rosenberg JE et al. Ann Oncol. 2023;341047-1054,

Toxicity Profile: EV + Pembro in Previously Untreated aUC

Abbreviation(s): Pembro: pembrolizumab.

Reference(s): Powles T et al. Ann Oncol. 2023;34(suppl_2):S1264-S1335,

Quality of Life in Patients With aUC Treated With First-Line EV Alone or With Pembro

Abbreviation(s): EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life
Questionnaire-Core Questionnaire
Reference(s): Milowsky MI et al. J Clin Oncol. 2024:42:1403-1414.

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Part 2 of 4: Best Practices in Monitoring for ADC-ICI Adverse Events

Andrea Necchi, MD

Associate Professor

Vita-Salute San Raffaele University
Director of GU Medical Oncology
IRCCS San Raffaele Hospital

Milan, Italy

Copyright © 2010-202.

14. PeerVoice

Andrea Necchi, MD, has a financial interest/relationship or affiliation in the
form of:
Consultant for AstraZeneca; Bristol Myers Squibb Company; Catalym GmbH; F.
Hoffmann-La Roche Ltd. Gilead Sciences, Inc.; Johnson & Johnson; Merck
KGaA; Merck Sharp & Dohme Corp. Pfizer Inc.; and Seagen Inc.

@ Grant/Research Support from Bristol Myers Squibb Company; Gilead Sciences,
Inc.; Incyte; and Merck Sharp & Dohme Corp.
Advisory Board for AstraZeneca; Bristol Myers Squibb Company; Catalym
GmbH; F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Johnson & Johnson;
Merck KGaA; Merck Sharp & Dohme Corp.; Pfizer Inc.; and Seagen Inc.

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AE Onset in Patients Treated With EV + Pembro

Median Times to Onset of Select AEs in Patients With
la/mUC Treated With EV + Pembro

1 4

eee

Hyperglycaemia 0 ()
0.5 mo

(range:03 to 35) Ô

|

Grade 23 skin reactions _)__

1.7 mo. ==
(range: O1 to 17.2) ==;

Stine Semcon nr

Pneumonitis
(range: 03 to 26) ¡Grade 22 peripheral
| neuropathy

6mo
(range: 0.3 to 25)

Y

An AE may occur at any point in time; data reflect patients with UC who received
3 (

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Monitoring of Treatment-Emergent Hyperglycaemia

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Mo

g of Treatment-Emergent Skin Reactions

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Monitoring of Treatment-Emergent Peripheral Neuropathy

Practice Guidelines
and symptoms of peripheral neuropathy and regularly assess
ies of daily living
Assess the extent of symptoms with simple tests (eg, picking up a coin, buttoning a
shirt, handwriting)
Inform patients about how peripheral neuropathy can manifest and that any

numbness and tingling of the hands or feet, muscle weakness (especially in legs, or
issues with balance) should be reported immediately

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Monitoring of Treatment-Emergent Pneumonitis

Symptoms
Dyspnoea
Cough
Chest pain
Fever
Hypoxia
May be asymptomatic but show inflammation on chest scans

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Monitoring of Treatment-Emergent Gastrointestinal Events

Practice Guidelines
Assess fluid and electrolyte status
Educate patients on the symptoms that should prompt immediate contact with
their healthcare provider
Perform work-up for colitis if patient experiences diarrhoea in conjunction with
abdominal pain, rectal bleeding, mucus in the stool, and fever

om/FED870

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Abbreviations and References

AE Onset in Patients Treated With EV + Pembro

Abbreviation(s): EV: enfortumab vedotin; la/mUC: locally-advanced or metastatic urothelial cancer;
Pembro: pembrolizumab; UC: urothelial cancer.
Reference(s): Brower B et al. Front Oncol. 2024,14:1326715.

Monitoring of Treatment-Emergent Hyperglycaemia

Reference(s): European Medicines Agency (EMA). https://www.ema.europa.eu/en/documents/product-
information/padcev-epar-product-information_en.paf. Accessed 25 September 2024.
Brower B et al. Front Oncol. 2024;14:1326715.

Monitoring of Treatment-Emergent Skin Reactions
Reference(s): EMA. https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-

information_en.pdf. Accessed 25 September 2024.
Brower B et al. Front Oncol. 2024;14:1326715.

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Abbreviations and References (Cont'd)

Monitoring of Treatment-Emergent Peripheral Neuropathy

Reference(s): EMA. https://www.emaeuropa.eu/en/documents/product-information/padcev-epar-product-
information_en.pdf. Accessed 25 September 2024.
Brower B et al. Front Oncol. 2024;14:1326715.

Monitoring of Treatment-Emergent Pneumonitis

Reference(s): EMA. https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-
information_en.pdf. Accessed 25 September 2024.
Brower B et al. Front Oncol. 2024;14:1326715.

Monitoring of Treatment-Emergent Gastrointestinal Events

Reference(s): EMA. https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-
information_en.pdf. Accessed 25 September 2024.
Brower B et al. Front Oncol. 2024141326715.

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Part 3 of 4: Preventing and Identifying Adverse Events:
The Importance of Patient Education

Andrea Necchi, MD

Associate Professor

Vita-Salute San Raffaele University
Director of GU Medical Oncology
IRCCS San Raffaele Hospital

Milan, Italy

Copyright © 2010-202.

24. PeerVoice

Andrea Necchi, MD, has a financial interest/relationship or affiliation in the
form of:
Consultant for AstraZeneca; Bristol Myers Squibb Company; Catalym GmbH; F.
Hoffmann-La Roche Ltd. Gilead Sciences, Inc.; Johnson & Johnson; Merck
KGaA; Merck Sharp & Dohme Corp. Pfizer Inc.; and Seagen Inc.

@ Grant/Research Support from Bristol Myers Squibb Company; Gilead Sciences,
Inc.; Incyte; and Merck Sharp & Dohme Corp.
Advisory Board for AstraZeneca; Bristol Myers Squibb Company; Catalym
GmbH; F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Johnson & Johnson;
Merck KGaA; Merck Sharp & Dohme Corp.; Pfizer Inc.; and Seagen Inc.

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Prevention of Treatment-Emergent Hyperglycaemia

What pre-existing clinical criteria can help predict therapy-related toxicities?

+ History of or ongoing DM and/or hyperglycaemia
BMI 230 kg/m?

lliness/infection

Use of systemic steroids

Underlying fatty liver disease

What preventive measures can help reduce the risk of hyperglycaemia?

+ Close monitoring of non-fasting blood glucose levels and for new or worsening symptoms of
DM during treatment

+ Consider endocrinology referral for patients at risk

+ In patients with underlying DM, ensure adequate control of blood glucose levels at baseline

+ Provide patient education on diet and lifestyle modification, and blood glucose testing

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Prevention of Treatment-Emergent Skin Reactions

What pre-existing clinical criteria can help predict therap

Prior history of a dermatologic condition (including immune-related disorders such as psoriasis or lupus)
Rash/pruritus

Allergies

Dry skin

Immunosuppression

High sun exposure

Prior cutaneous reactions to previous lines of anticancer therapies

‘Skin damage due to therapeutic radiation

Barrier protectants (eg, zinc-containing moisturisers)
Sunscreen
Emollients
Mild skin cleaners

Advise patients to contact their healthcare
provider immediately if they develop new target

lesions, progressively worsening skin reactions,
severe blistering, or peeling skin.

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Prevention of Treatment-Emergent Peripheral Neuropathy

+ Certain anticancer therapies, including MMAE-containing ADCs
+ Comorbidities (eg, DM)

+ Older age

+ Spinal involvement of mUC

+ Nonmalignant spinal disease

+ Provide patient education on signs and symptoms
+ Monitor closely with early, conservative intervention to prevent peripheral neuropathy from
becoming severe
Patients may be reluctant to report signs of peripheral
neuropathy. They should be told that dose modifications may

help avoid worsening symptoms that could impact their
activities of daily living or require treatment discontinuation

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Prevention of Treatment-Emergent Pneumonitis

ae >

+ Prior thoracic radiation (immune-mediated pneumonitis)
+ History of underlying pulmonary disease

+ Careful monitoring of any respiratory symptom or sign
« Patient education on the symptoms they should inform their healthcare provider of
immediately

Monitor patients for signs and symptoms indicative of
pneumonitis/ILD such as hypoxia, cough, dyspnoea, or
interstitial infiltrates on radiologic exams. Evaluate and

exclude infectious, neoplastic, and other causes for such
signs and symptoms through appropriate investigations.

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Prevention of Treatment-Emergent Gastrointestinal Events

What pre-existing clinical criteria can help predict therapy-related toxicities?

+ Immunotherapy

What preventive measures can help reduce the risk of gastrointestinal events?

+ Ensure adequate nutrition and hydration
+ Avoid foods with strong smells
+ Small, frequent meals

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Abbreviations and References

Prevention of Treatment-Emergent Hyperglycaemia

Abbreviation(s): DM: diabetes mellitus.
Reference(s): Brower B et al. Front Oncol. 2024;14:1326715,

Prevention of Treatment-Emergent Skin Reactions

Reference(s): Brower B et al. Front Oncol. 2024,14:1326715.
European Medicines Agency (EMA). https://www.ema.europa.eu/en/documents/product-information/padcev-epar-
product-information_enpdf. Accessed 25 September 2024.

Prevention of Treatment-Emergent Peripheral Neuropathy

Abbreviation(s): ADC: antibody-drug conjugate; MMAE: monomethyl auristatin E; mUC: metastatic urothelial carcinoma.
Reference(s): Brower B et al. Front Oncol. 2024;14:1326715.

EMA. https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf.
Accessed 25 September 2024,

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Abbreviations and References (Cont'd)

Prevention of Treatment-Emergent Pneumonitis

Abbreviation(s): ILO: interstitial lung disease.
Reference(s): Brower B et al. Front Oncol. 2024;14:1326715.
EMA https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdt.

Accessed 25 September 2024.

Prevention of Treatment-Emergent Gastrointestinal Events
Reference(s): Brower B et al. Front Oncol. 2024;14:13267165.

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Part 4 of 4: Responding to Adverse Events: Dose Modifications
and Supportive Measures

Andrea Necchi, MD

Associate Professor

Vita-Salute San Raffaele University
Director of GU Medical Oncology
IRCCS San Raffaele Hospital

Milan, Italy

Copyright © 2010-202.

33. PeerVoice

Andrea Necchi, MD, has a financial interest/relationship or affiliation in the
form of:
Consultant for AstraZeneca; Bristol Myers Squibb Company; Catalym GmbH; F.
Hoffmann-La Roche Ltd. Gilead Sciences, Inc.; Johnson & Johnson; Merck
KGaA; Merck Sharp & Dohme Corp. Pfizer Inc.; and Seagen Inc.

@ Grant/Research Support from Bristol Myers Squibb Company; Gilead Sciences,
Inc.; Incyte; and Merck Sharp & Dohme Corp.
Advisory Board for AstraZeneca; Bristol Myers Squibb Company; Catalym
GmbH; F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Johnson & Johnson;
Merck KGaA; Merck Sharp & Dohme Corp.; Pfizer Inc.; and Seagen Inc.

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Managing Treatment-Emergent Hyperglycemia

Reaction Severity Modification

+ Withhold until elevated blood glucose has
improved to <13.9 mmol/L (<250 mg/dL)
+ Resume treatment at the same dose level

Blood glucose >13.9 mmol/L

Hyperglycaemia | („280 g/dl)

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Managing Treatment-Emergent Skin Reactions

Suspected Stevens-Johnson
syndrome (SJS) or toxic
epidermal necrolysis (TEN) or
bullous lesions

Confirmed SJS or TEN; grade
4 or recurrent grade 3

+ Immediately withhold, refer to specialised care

Skin reactions + Permanently discontinue

+ Withhold until grade <1
+ Referral to specialised care should be considered
+ Resume at the same dose level or consider dose

reduction by one dose level (see below)

Grade 2 worsening;
grade 2 with fever;
grade 3

EV starting d

vels due to AE:

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Managing Treatment-Emergent Peripheral Neuropathy

Reaction Severity Modification
+ Withhold until grade <1
+ For first occurrence, resume treatment
Cba at the same dose level

+ For a recurrence, withhold until grade
Peripheral neuropathy <1, then resume treatment reduced by
one dose level (see below)

Grade 23 + Permanently discontinue

due to AE:

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Impact of EV Dose Reduction/Exposure on Patient Outcomes

EV Dose Level by Cycle in EV-301

EV dose level:
N 125 mare
3 M 100 mark
Sx ER
És
58
é
67 89D NDE M BH 1 Bw 202172232425262778
cycle
444(375-677) EV oxposure quartile
mPFS 7.36 (630-220 M QI Q2 a Qs mas
(eswen 562 (509-726)
565(832-723) Control: m cht
3.71 (352-394)

n (289-152) ee
Br 151 (108-NE)
15.2(9.63-NE)
(95% cI) 126 (9.79-NE)

8.97 (805-1074)

Cat (n= 307)

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Abbreviations and References

Managing Treatment-Emergent Hyperglycemia

Reference(s): European Medicines Agency (EMA). https://www.ema.europa.eu/en/documents/product-
information/padcev-epar-product-information_en.paf. Accessed 25 September 2024.

Managing Treatment-Emergent Skin Reactions

Abbreviation(s): EV: enfortumab vedotin.

Reference(s): EMA. https://www.emaeuropa.eu/en/documents/product-information/padcev-epar-product-
information_en.pdt. Accessed 25 September 2024.

Managing Treatment-Emergent Peripheral Neuropathy

Reference(s): EMA. https://www.emaeuropa.eu/en/documents/product-information/padcev-epar-product-
information_en.pdf. Accessed 25 September 2024.

Impact of EV Dose Reduction/Exposure on Patient Outcomes

Abbreviation(s): ADC: antibody-drug conjugate; Ca: time-averaged exposure over the entire treatment duration;
ChT: chemotherapy; NE: not evaluable; Q: quartile.
Reference(s): Petrylak DP et al. J Clin Oncol. 2024;42(suppl_16). doi:10:1200/JC0.2024.42.16_suppl.4503.

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