UNC Lineberger Cancer Network Presented on April 28, 2021

For Educational Use Only 1

Genitourinary Oncology Update 2021

Matthew Milowsky MDApril 28, 2021

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Disclosures• Employment - none

• Leadership - none

• Stock and Other Ownership Interests – none

• Honoraria - none

• Consulting or Advisory Role – none

• Speaker’s Bureau - none

• Research Funding (institution)– Merck, Roche/Genentech, Bristol-Myers Squibb, Seagen, Astellas Pharma, Clovis Oncology, Inovio Pharmaceuticals, Mirati Therapeutics, Constellation Pharmaceuticals, Syndax, Incyte, Amgen, Regeneron, Arvinas, Pfizer, Johnson & Johnson/Janssen

• Patents, Royalties, Other Intellectual Property – none

• Expert Testimony - none

• Travel, Accommodations, Expenses - none

• Other Relationship - none

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2021 GU Cancers Symposium Highlights

Lu-177-PSMA therapy for prostate cancer

Enfortumab Vedotin for advanced urothelial cancer

and more…

ADC, radioligand therapy, adjuvant immunotherapy,

Adjuvant Nivolumab in MIUC

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UNC Lineberger Cancer Network Presented on April 28, 2021

For Educational Use Only 2

Prostate Cancer Update

1. TheraP (ANZUP 1603) – Lu-177-PSMA in mCRPC2. ACIS – Apa/Abi vs. Abi in mCRPC

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TheraP (ANZUP 1603)

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177-Lu-PSMA-617

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UNC Lineberger Cancer Network Presented on April 28, 2021

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TheraP (ANZUP 1603)

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TheraP (ANZUP 1603)

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TheraP (ANZUP 1603)

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UNC Lineberger Cancer Network Presented on April 28, 2021

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TheraP (ANZUP 1603)

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TheraP (ANZUP 1603)

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TheraP (ANZUP 1603)

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UNC Lineberger Cancer Network Presented on April 28, 2021

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Press Release (3/23/2021): Phase III VISION study

https://www.novartis.com/news/media-releases/novartis-announces-positive-result-phase-iii-study-radioligand-therapy-177lu-psma-617-patients-advanced-prostate-cancer

Likely practice changing (awaiting data)

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ACIS

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ACIS

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UNC Lineberger Cancer Network Presented on April 28, 2021

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ACIS

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ACIS

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ACIS

No OS benefit seen

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UNC Lineberger Cancer Network Presented on April 28, 2021

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ACIS

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ACIS – Not practice changing without improvement in OS

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Bladder Cancer Update

1. EV-301– EV vs. Chemotherapy in mUC (previously treated)2. EV-201 – EV in cisplatin-unfit mUC (prior IO)3. CheckMate 274 – adjuvant Nivolumab in high-risk MIUC

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UNC Lineberger Cancer Network Presented on April 28, 2021

For Educational Use Only 8

EV-301

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Enfortumab Vedotin

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EV-301

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UNC Lineberger Cancer Network Presented on April 28, 2021

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EV-301

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EV-301

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EV-301

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UNC Lineberger Cancer Network Presented on April 28, 2021

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EV-301

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EV-301

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EV-301

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UNC Lineberger Cancer Network Presented on April 28, 2021

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EV-301 – Practice changing

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EV-201

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EV-201

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UNC Lineberger Cancer Network Presented on April 28, 2021

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EV-201

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EV-201

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EV-201

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UNC Lineberger Cancer Network Presented on April 28, 2021

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EV-201

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EV-201

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EV-201

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UNC Lineberger Cancer Network Presented on April 28, 2021

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EV-201 – Promising but not practice changing at this time

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CheckMate 274

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CheckMate 274

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UNC Lineberger Cancer Network Presented on April 28, 2021

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CheckMate 274

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CheckMate 274

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CheckMate 274

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UNC Lineberger Cancer Network Presented on April 28, 2021

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CheckMate 274

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CheckMate 274

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CheckMate 274

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UNC Lineberger Cancer Network Presented on April 28, 2021

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CheckMate 274 – Potential to be practice changing…

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IMvigor 010

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IMvigor 010

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UNC Lineberger Cancer Network Presented on April 28, 2021

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IMvigor 010

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ALLIANCE A031501: Phase III randomized “Adjuvant study of peMBrolizumAb in muScle invaSive and locAlly aDvanced urOthelial carcinoma” (AMBASSADOR) versus observation

Pembrolizumab200mg q3W

1 year

Observation

RANDOMIZE

Eligibility

§ M IBC or UTUC

Radical cystectomy nephrectomy, nephroureterectomy or ureterectomy ≥4 but ≤ 16 weeks

§Post-neoadjuvant chemotherapy and ≥ pT2 and/or N+

OR§cisplatin-ineligible and ≥ pT3 or pN+/+margins

OR§decline adjuvant chemo and ≥ pT3 or pN+/+ margins

DISEASE

FREE

SURVIVAL

Stratify§ PDL1 +/-

§ Neoadjuvantchemotherapyyes/no

§ Pathologic stage: pT2/3/4aN0 vs pT4bNx orN1-3 vs +microscopic invasive margins

1:1

OVERALL

SURVIVAL

N=739

Co-primary

Presented by Andrea B. Apolo

Central PD-L1 testing

Pre-registrationRegistration

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Kidney Cancer Update

1. CLEAR – Len/Pem in advanced ccRCC2. SWOG 1500 – Cabo in pRCC

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UNC Lineberger Cancer Network Presented on April 28, 2021

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CLEAR

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CLEAR

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CLEAR

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UNC Lineberger Cancer Network Presented on April 28, 2021

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CLEAR

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CLEAR

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CLEAR

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UNC Lineberger Cancer Network Presented on April 28, 2021

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CLEAR

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CLEAR

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CLEAR

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UNC Lineberger Cancer Network Presented on April 28, 2021

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CLEAR – Practice changing as another IO/VEGFR TKI combo

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First-line options for metastatic ccRCC

c/o Dr. Tracy Rose, UNC

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SWOG 1500

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UNC Lineberger Cancer Network Presented on April 28, 2021

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SWOG 1500

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SWOG 1500

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SWOG 1500

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UNC Lineberger Cancer Network Presented on April 28, 2021

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SWOG 1500

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SWOG 1500 – Practice changing as new standard for pRCC

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2021 GU Cancers Symposium Highlights

• Thank you for your attention.

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