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post-ASCO 2018 Prostata Kræft- Nyheder fra ASCO 2018 Dag Stormoen Junior Speaker H-Læge Onkologi Gedske Daugaard Senior Speaker Professor Onkologi

post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

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Page 1: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

post-ASCO 2018

Prostata Kræft- Nyheder fra ASCO 2018

Dag Stormoen Junior Speaker

H-Læge Onkologi

Gedske Daugaard Senior Speaker

Professor Onkologi

Page 2: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Abstracts

#5000 SPCG-13 Adjuverende Docetaxel ved strålebehandling

#5001 ADT +/- Abiraterone Abiraterone med eller uden LHRH til patienter PSA recidiv med M0HSPC

#5002 Prospect Prostvac til mCRPC

#5006 PSMA PET/CT 68Ga-PSMA11 PET/CT

Page 3: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

A randomized phase III trial between adjuvant docetaxel

and surveillance after radical radiotherapy for intermediate

and high risk prostate cancer: Results of SPCG-13 trial. Presented Monday, June 4, 2018

Abstract #: 5000

Page 4: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 5: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Biokemisk progression PSA >2.0ng/ml

SPCG 13 - Data presented ASCO 2018

Page 6: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

SPCG 13 - Data presented ASCO 2018

INGEN FORSKEL PÅ PSA PROGRESSIONSFRI OVERLEVELSE

Page 7: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Tendens tyder på effekt hos højrisiko pt.

Page 8: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

KONKLUSION SPCG - 13

- Adjuvant docetaxel øger ikke PSA fri overlevelse efter radikal RT for

intermediær eller højrisiko prostata kræft.

- Biokemisk progressionsrate var lavere end forventet i begge arme i studiet

- Studiet støtter SPCG -12

Page 9: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

A randomized study of finite abiraterone acetate (AA) plus

leuprolide (LHRHa) versus LHRHa in biochemically

recurrent non metastatic hormone naïve prostate cancer

(M0HNPC). Presented Monday, June 4, 2018

Abstract #: 5002

Page 10: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

LHRH agonist +/- Abiraterone for biokemisk recidiv

af M0, hormon naïve PCa (Efstathiou et al):

28.3 mnd (24.2-35.4)

21.1 mnd (19.1-27.2)

HR 0.62 (95% CI 0.44-0.88; p0.007)

Page 11: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

AA+LHRH vs LHRH in M0HNPC med HR 0.62

- Den eksperimentelle arm kom favorabelt ud til fordel for AA + LHRH med en

HR på 0.62.

- Tillæg af Abiraterone Acetat forlænger ikke tid til Testosteron recovery

hvilket er essentielt for QOL og langtidsbivirkninger.

Page 12: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Results of PROSPECT: A randomized phase 3 trial of

PROSTVAC-V/F (PRO) in men with asymptomatic or

minimally symptomatic metastatic, castration-resistant

prostate cancer. Presented Monday, June 4, 2018

Abstract #: 5006

Page 13: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 14: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

FASE 2 i 2010 - Prostvac 8.5mnd OS benefit

Page 15: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 16: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

PROSTVAC - Data presented ASCO 2018

Overall survival - ITT

Page 17: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Accuracy of 68Ga-PSMA11 PET/CT on recurrent prostate

cancer: Preliminary results from a phase 2/3 prospective

trial. Presented Monday, June 4, 2018

Abstract #: 5006

Page 18: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Keypoints

- 250 patienter blev inkluderet i studiet (38% PSA <1, 82% r/p, 34% Gl. >8)

- PSA < 1 -- fund af læsion i 40%

- PSA > 1 -- fund af læsion i 80%

- 78% af fundne læsioner var ikke lokale

Page 19: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 20: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Lokal behandling

Påvirkning af testosteron niveauet

Behandling efter LHRH agonister

og antiandrogener

Kemoterapi

Efter kemoterapi

Død

Kirurgi/strålebe-handling

Standard antihormon behandling

Tidlig docetaxel

Docetaxel -Taxotere Cabazitaxel - Jevtana

Abirateron - Zytiga

Enzalutamide - Xtandi

Radium-223 – Alfaradin -

Xofigo

Denosumab (Xgeva), Zoledronic Acid (Zometa)

Tidlig abirateron

Strålebehandling med 18 vs 36 mdr. ADT

AD-RAD

Ga-PSMA PET/CT

Prostvac

LHRH + abirateron

x x

Page 21: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Lokal behandling

Påvirkning af testosteron niveauet

Behandling efter LHRH agonister

og antiandrogener

Kemoterapi

Efter kemoterapi

Død

Kirurgi/strålebe-handling

Standard antihormon behandling

Tidlig docetaxel

Docetaxel -Taxotere Cabazitaxel - Jevtana

Abirateron - Zytiga

Enzalutamide - Xtandi

Radium-223 – Alfaradin -

Xofigo

Denosumab (Xgeva), Zoledronic Acid (Zometa)

Tidlig abirateron

Strålebehandling med 18 vs 36 mdr. ADT

AD-RAD

Ga-PSMA PET/CT

Prostvac

LHRH + abirateron

x x AR-V7 splice varianter

Page 22: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 23: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Among the contributors to castration-resistant Prostate Cancer are AR splice variants that lack the ligand-binding domain

Page 24: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 25: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 26: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Lokal behandling

Påvirkning af testosteron niveauet

Behandling efter LHRH agonister

og antiandrogener

Kemoterapi

Efter kemoterapi

Død

Kirurgi/strålebe-handling

Standard antihormon behandling

Tidlig docetaxel

Docetaxel -Taxotere Cabazitaxel - Jevtana

Abirateron - Zytiga

Enzalutamide - Xtandi

Radium-223 – Alfaradin -

Xofigo

Denosumab (Xgeva), Zoledronic Acid (Zometa)

Tidlig abirateron

Strålebehandling med 18 vs 36 mdr. ADT

AD-RAD

Ga-PSMA PET/CT

Prostvac

LHRH + abirateron

x x AR-V7 splice varianter

Pembrolisumab

Page 27: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 28: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 29: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 30: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 31: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 32: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 33: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 34: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Lokal behandling

Påvirkning af testosteron niveauet

Behandling efter LHRH agonister

og antiandrogener

Kemoterapi

Efter kemoterapi

Død

Kirurgi/strålebe-handling

Standard antihormon behandling

Tidlig docetaxel Docetaxel -Taxotere Cabazitaxel - Jevtana

Abirateron - Zytiga

Enzalutamide - Xtandi

Radium-223 – Alfaradin -

Xofigo

Denosumab (Xgeva), Zoledronic Acid (Zometa)

Tidlig abirateron

Strålebehandling med 18

vs 36 mdr. ADT

PARP-hæmmer: patienter med Homolog Recombination Deficiency, forandringer I BRCA eller ATM mutation

Page 35: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Lokal behandling

Påvirkning af testosteron niveauet

Behandling efter LHRH agonister

og antiandrogener

Kemoterapi

Efter kemoterapi

Død

Kirurgi/strålebe-handling

Standard antihormon behandling

Tidlig docetaxel

Docetaxel -Taxotere Cabazitaxel - Jevtana

Abirateron - Zytiga

Enzalutamide - Xtandi

Radium-223 – Alfaradin -

Xofigo

Denosumab (Xgeva), Zoledronic Acid (Zometa)

Tidlig abirateron

Strålebehandling med 18 vs 36 mdr. ADT

AD-RAD

Ga-PSMA PET/CT

Prostvac

LHRH + abirateron

x x AR-V7 splice varianter

Pembrolisumab

Olaparib + abi vs abirateron

Page 36: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 37: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

homologous recombination repair mutation (HRRm) status was assessed using optional tumor (n = 68), whole-blood and plasma samples

Page 38: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Statistically significant increase in rPFS seen with the combination (13.8 months) vs abiraterone alone (8.2 month), a 5.6 month PFS benefit (HR 0.65, P= 0.03)

Page 39: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

homologous recombination repair mutation (HRRm)

status did not seem to impact this benefit

Page 40: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 41: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 42: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Lokal behandling

Påvirkning af testosteron niveauet

Behandling efter LHRH agonister

og antiandrogener

Kemoterapi

Efter kemoterapi

Død

Kirurgi/strålebe-handling

Standard antihormon behandling

Tidlig docetaxel

Docetaxel -Taxotere Cabazitaxel - Jevtana

Abirateron - Zytiga

Enzalutamide - Xtandi

Radium-223 – Alfaradin -

Xofigo

Denosumab (Xgeva), Zoledronic Acid (Zometa)

Tidlig abirateron

Strålebehandling med 18 vs 36 mdr. ADT

AD-RAD

Ga-PSMA PET/CT

Prostvac

LHRH + abirateron

AR-V7 splice varianter

Pembrolisumab

Olaparib + abi vs abirateron

Radium223 standard vs

højdosis vs 12 serier

Page 43: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 44: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 45: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract
Page 46: post-ASCO 2018 · PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer. Presented Monday, June 4, 2018 Abstract

Lokal behandling

Påvirkning af testosteron niveauet

Behandling efter LHRH agonister

og antiandrogener

Kemoterapi

Efter kemoterapi

Død

Kirurgi/strålebe-handling

Standard antihormon behandling

Tidlig docetaxel

Docetaxel -Taxotere Cabazitaxel - Jevtana

Abirateron - Zytiga

Enzalutamide - Xtandi

Radium-223 – Alfaradin -

Xofigo

Denosumab (Xgeva), Zoledronic Acid (Zometa)

Tidlig abirateron

Strålebehandling med 18 vs 36 mdr. ADT

AD-RAD

Ga-PSMA PET/CT

Prostvac

LHRH + abirateron

x x AR-V7 splice varianter

Pembrolisumab

Olaparib + abi vs abirateron

Radium223 standard vs

højdosis vs 12 serier ? x

Prostata cancer