From Platform to Practice: Insights From ESMO 2025 on the Latest Data Guiding Contemporary Care in mHSPC and nmCRPC
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Oct 24, 2025
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About This Presentation
Fred Saad, MD, FRCS, and Alicia K. Morgans, MD, MPH, discuss advanced prostate cancer in this CE activity titled “From Platform to Practice: Insights From ESMO 2025 on the Latest Data Guiding Contemporary Care in mHSPC and nmCRPC.” For the full presentation, please visit us at www.peervoice.com/...
Slide Content
PeerVoice
From Platform to Practice: Insights From ESMO 2025 on the Latest Data
Guiding Contemporary Care in mHSPC and nmCRPC
Learning Objectives
Evaluate novel data presented at ESMO 2025 related to the use of androgen
receptor pathway inhibitors (ARPIs) in the management of metastatic hormone-
sensitive prostate cancer (mHSPC) and nonmetastatic castration-resistant
prostate cancer (nmCRPC), including relevant efficacy and safety data,
subgroup analyses, and real-world evidence
Assess the potential implications of recently presented findings for the clinical
care of individuals living with mHSPC or nmCRPC
This activity is supported by an unrestricted educational grant from Bayer HealthCare Pharmaceuticals Inc. Bayer has had
no involvement in the selection of the speakers, the development of the activity, the agenda or the materials.
PeerVoice is an EBAC* accredited provider since 2022
Copyright © 2010-202
www.peervoice.com/XKC870
From Platform to Practice: Insights From ESMO 2025 on the Latest Data
Guiding Contemporary Care in mHSPC and nmCRPC
Learning Objectives
Evaluate novel data presented at ESMO 2025 related to the use of androgen
receptor pathway inhibitors (ARPIs) in the management of metastatic hormone-
sensitive prostate cancer (mHSPC) and nonmetastatic castration-resistant
prostate cancer (nmCRPC), including relevant efficacy and safety data,
subgroup analyses, and real-world evidence
Assess the potential implications of recently presented findings for the clinical
care of individuals living with mHSPC or nmCRPC
This activity is supported by an unrestricted educational grant from Bayer HealthCare Pharmaceuticals Inc. Bayer has had
no involvement in the selection of the speakers, the development of the activity, the agenda or the materials.
PeerVoice is an EBAC* accredited provider since 2022
Copyright © 2010-202
www.peervoice.com/XKC870
PeerVoice
Part 1 of 2: In Case You Missed It: Exploring Evidence in mHSPC and
nmCRPC From ESMO 2025
Fred Saad, MD, FRCS Alicia K. Morgans, MD, MPH
Professor of Surgery/Urology Associate Professor
University of Montreal Harvard Medical School
Chairman of Surgery Director, Adult Survivorship
University of Montreal Hospital Center | Dana-Farber Cancer Institute
Montreal, Quebec, Canada Boston, Massachusetts, USA
Copyright © 2010-2025, Poervoi
Part 1 of 2: In Case You Missed It: Exploring Evidence in mHSPC and
nmCRPC From ESMO 2025
Fred Saad, MD, FRCS Alicia K. Morgans, MD, MPH
Professor of Surgery/Urology Associate Professor
University of Montreal Harvard Medical School
Chairman of Surgery Director, Adult Survivorship
University of Montreal Hospital Center | Dana-Farber Cancer Institute
Montreal, Quebec, Canada Boston, Massachusetts, USA
Copyright © 2010-2025, Poervoi
PeerVoice
Fred Saad, MD, FRCS, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc.; AstraZeneca; Bayer AG; Bristol Myers Squibb Company;
GSK plc; Janssen Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc; Sumitomo Pharma Co, Lt
TerSera Therapeutics LLC; and Tolmar Inc.
Grant/Research Support from Astellas Pharma Inc; AstraZeneca; Bayer AG; Bristol Myers Squibb
Company; GSK ple; Janssen Inc.; Merck & Co, Inc.; Novartis AG; and Pfizer Inc.
Advisory Board for Astellas Pharma Inc.; AstraZeneca; Bayer AG; Bristol Myers Squibb Company;
GSK ple; Janssen Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc.; Sumitomo Pharma Co, Ltd;
TerSera Therapeutics LLC; and Tolmar Inc.
Speaker or participant in accredited CME/CPD for Astellas Pharma Inc.; AstraZeneca; Bayer AG;
Bristol Myers Squibb Company; GSK ple Janssen Inc. Merck & Co, Inc.; Novartis AG; Pfizer Inc;
Sumitomo Pharma Co, Ltd; TerSera Therapeutics LLC; and Tolmar Inc.
Alicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc; AstraZeneca; Bayer AG; Curium; Dendreon Pharmaceuticals
LLC; Exelixis, Inc; Lantheus; MacroGenics, Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc.; Telix
Pharmaceuticals Ltd; and Tolmar Inc.
Grant/Research Support from Astellas Pharma Inc; Bayer AG; Bristol Myers Squibb Company;
Exact Sciences Corp; Lantheus; Novartis AG; Pfizer Inc.; and Sumitomo Pharma Co, Ltd.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
Fred Saad, MD, FRCS, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc.; AstraZeneca; Bayer AG; Bristol Myers Squibb Company;
GSK plc; Janssen Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc; Sumitomo Pharma Co, Lt
TerSera Therapeutics LLC; and Tolmar Inc.
Grant/Research Support from Astellas Pharma Inc; AstraZeneca; Bayer AG; Bristol Myers Squibb
Company; GSK ple; Janssen Inc.; Merck & Co, Inc.; Novartis AG; and Pfizer Inc.
Advisory Board for Astellas Pharma Inc.; AstraZeneca; Bayer AG; Bristol Myers Squibb Company;
GSK ple; Janssen Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc.; Sumitomo Pharma Co, Ltd;
TerSera Therapeutics LLC; and Tolmar Inc.
Speaker or participant in accredited CME/CPD for Astellas Pharma Inc.; AstraZeneca; Bayer AG;
Bristol Myers Squibb Company; GSK ple Janssen Inc. Merck & Co, Inc.; Novartis AG; Pfizer Inc;
Sumitomo Pharma Co, Ltd; TerSera Therapeutics LLC; and Tolmar Inc.
Alicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc; AstraZeneca; Bayer AG; Curium; Dendreon Pharmaceuticals
LLC; Exelixis, Inc; Lantheus; MacroGenics, Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc.; Telix
Pharmaceuticals Ltd; and Tolmar Inc.
Grant/Research Support from Astellas Pharma Inc; Bayer AG; Bristol Myers Squibb Company;
Exact Sciences Corp; Lantheus; Novartis AG; Pfizer Inc.; and Sumitomo Pharma Co, Ltd.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
PeerVoice
ARASAFE: Study Design
‘Open-label phase 3 Primary endpoints
& |: Safety: Grade 3-5 AEs
Patients (N = 250) STD: Darolutamide 600 mg BID + ADT © |< Safety: Grade 3-4 neutropenia or death
2° mHSPC el 75 mg/m? Q3W (3-wk cycle) Él of any reason
+ ECOG PSO or! 50 mg/m? 2
Candidates for darolutamide, à | Secondary endpoints
ADT, and docetaxel 3 |- Time to cerec
+ os
Extent of disease (high vs low) eae she E |- Time to first SSE
ALP (6 vs 2ULN) ale ida E |- Time to initiation of subsequent systemic
& | antineoplastic therapy
ra + Time to worsening of disease-related
FEV: May 2023 physical symptoms
LPFV: Dec 2024 + QOL (exploratory)
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ARASAFE: Study Design
‘Open-label phase 3 Primary endpoints
& |: Safety: Grade 3-5 AEs
Patients (N = 250) STD: Darolutamide 600 mg BID + ADT © |< Safety: Grade 3-4 neutropenia or death
2° mHSPC el 75 mg/m? Q3W (3-wk cycle) Él of any reason
+ ECOG PSO or! 50 mg/m? 2
Candidates for darolutamide, à | Secondary endpoints
ADT, and docetaxel 3 |- Time to cerec
+ os
Extent of disease (high vs low) eae she E |- Time to first SSE
ALP (6 vs 2ULN) ale ida E |- Time to initiation of subsequent systemic
& | antineoplastic therapy
ra + Time to worsening of disease-related
FEV: May 2023 physical symptoms
LPFV: Dec 2024 + QOL (exploratory)
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ARASAFE: Baseline Patient and Disease Characteristics
Docetaxel Docetaxel
Charact 75 mg/m? Q3W
(n 9) (n =121)
Median age, y (IQR) 68 (63-74) 67 (63-73)
ECOG PS 0/1, % 78.3 | 21.7 86.8 / 13.2
Gleason score 28 at study entry, % 814 80.2
Cancer met pattern at study entry, %
Nonregional lymph node only 0.8 o
Bone/nonvisceral 83.7 88.4
Visceral/other 15.5 1.6
Extent of disease — high volume, % 83.7 86.0
ALP stratification - 2ULN, % 56.6 60.3
Median serum PSA, ng/mL (IQR) 12.2 (2.2-75) 14.7 (3.6-57.7)
Drug exposure — docetaxel
Mean number of doses (SD) 5.6 (11) 10.7 (2.2)
Mean cumulative dose, mg (SD) 842.8 (1817) 1073.5 (240.4)
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ARASAFE: Baseline Patient and Disease Characteristics
Docetaxel Docetaxel
Charact 75 mg/m? Q3W
(n 9) (n =121)
Median age, y (IQR) 68 (63-74) 67 (63-73)
ECOG PS 0/1, % 78.3 | 21.7 86.8 / 13.2
Gleason score 28 at study entry, % 814 80.2
Cancer met pattern at study entry, %
Nonregional lymph node only 0.8 o
Bone/nonvisceral 83.7 88.4
Visceral/other 15.5 1.6
Extent of disease — high volume, % 83.7 86.0
ALP stratification - 2ULN, % 56.6 60.3
Median serum PSA, ng/mL (IQR) 12.2 (2.2-75) 14.7 (3.6-57.7)
Drug exposure — docetaxel
Mean number of doses (SD) 5.6 (11) 10.7 (2.2)
Mean cumulative dose, mg (SD) 842.8 (1817) 1073.5 (240.4)
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ARASAFE: Primary Endpoints
Docetaxel Docetaxel
Endpoint, % (95% Cl) 75 mg/m? Q3W 50 mg/m? Q2W
(n =128) (n= 121)
Grade 3-5 AE rates 78.9 (70.8-85.6) 61.2 (51.9-69.9) .0024
Grade 3-4 neutropenia/death | 64.1(55.1-72.3) 24.0 (16.7-32.6) <.0001
STD: 6 x docetaxel 75 mg/m? Q3W (3-wk cycle) —+ Docetaxel application STD
End of study ==» Additional blood sample (safety lab)
treatment visit
— Docetaxel application EXP
==> Additional blood sample (safety lab)
‘Observation
wis. W22 _W26+1wk
Darolutamide 2 x 600 mg/d + ADT
Copyright © 2010-2025, PeerVoice
ARASAFE: Primary Endpoints
Docetaxel Docetaxel
Endpoint, % (95% Cl) 75 mg/m? Q3W 50 mg/m? Q2W
(n =128) (n= 121)
Grade 3-5 AE rates 78.9 (70.8-85.6) 61.2 (51.9-69.9) .0024
Grade 3-4 neutropenia/death | 64.1(55.1-72.3) 24.0 (16.7-32.6) <.0001
STD: 6 x docetaxel 75 mg/m? Q3W (3-wk cycle) —+ Docetaxel application STD
End of study ==» Additional blood sample (safety lab)
treatment visit
— Docetaxel application EXP
==> Additional blood sample (safety lab)
‘Observation
wis. W22 _W26+1wk
Darolutamide 2 x 600 mg/d + ADT
Copyright © 2010-2025, PeerVoice
PeerVoice
ARASAFE: Safety Outcomes
Docetaxel Docetaxel
75 mg/m? Q3W 50 mg/m? Q2W
(n= 128)
AllGrades Gra
‘Anaerni 836 y 50
Neutropenia 750 207
Leucopenia 695 250 EN
Lymphopenia 269 78 ns
Alopeci 430 o 339 o
Fatigue) 391 08 455 33
Leucocytosis 242 39 165 17
Dysgeusia 219 o 264 o
Peripheral sensory neuropathy au 08 182 o
Peripheral oedema 195 o 207 o
ALT increased 164 39 190 25
Diarrhoea ar 08 157 08
‘AST increased 125 08 157 08
Nail disorder EX] o 207 17
Epistaxis 62 o 182 o
Febrile neutropenia 55 55 17 17
TEAES 215
at least one treatment arm, and febrile neutropeni
\cluded in secondary safety variable).
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ARASAFE: Safety Outcomes
Docetaxel Docetaxel
75 mg/m? Q3W 50 mg/m? Q2W
(n= 128)
AllGrades Gra
‘Anaerni 836 y 50
Neutropenia 750 207
Leucopenia 695 250 EN
Lymphopenia 269 78 ns
Alopeci 430 o 339 o
Fatigue) 391 08 455 33
Leucocytosis 242 39 165 17
Dysgeusia 219 o 264 o
Peripheral sensory neuropathy au 08 182 o
Peripheral oedema 195 o 207 o
ALT increased 164 39 190 25
Diarrhoea ar 08 157 08
‘AST increased 125 08 157 08
Nail disorder EX] o 207 17
Epistaxis 62 o 182 o
Febrile neutropenia 55 55 17 17
TEAES 215
at least one treatment arm, and febrile neutropeni
\cluded in secondary safety variable).
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PeerVoice
ARANOTE Post-Hoc: Study Design
Phase 3
HAE BID + ADT
Boa PS 0-2
Stratitication
ceral mets (Y vs N)
Prior local therapy (Y vs N)
Primary endpoint
+ 1PFS by central blinded review
Secondary endpoints
Time to mCRPC
Time to PSA progression
Rates of PSA <0.2 ng/mL
Safety
Age Distribution (All Randomised Patients)
27% 43%
= 183 n= 289
Median, 60 y Median, 69 y
29%
n=197
Median, 79 y
Data cutoff 7 June 2024.
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ARANOTE Post-Hoc: Study Design
Phase 3
HAE BID + ADT
Boa PS 0-2
Stratitication
ceral mets (Y vs N)
Prior local therapy (Y vs N)
Primary endpoint
+ 1PFS by central blinded review
Secondary endpoints
Time to mCRPC
Time to PSA progression
Rates of PSA <0.2 ng/mL
Safety
Age Distribution (All Randomised Patients)
27% 43%
= 183 n= 289
Median, 60 y Median, 69 y
29%
n=197
Median, 79 y
Data cutoff 7 June 2024.
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ARANOTE Post-Hoc: Efficacy Outcomes
rPFS
Favgurs Dero Favours PEO HR(S5%0)
Overall population rar 054 (01-071)
68 y 0.44(027-0.71)
65-74 y 064 (042-028)
275y 051 (031-084)
où 0
Time to PSA Progression
Favgurs Doro — Favours PBO HR(OSKCH
Overall population —+— 0.31(0.23-0.41)
«sy — 028 (017-046)
65-74y == 031(0.20-0.48)
275y — 033 (018-058)
or 10 0
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Time to mCRPC
Fovgurs Daro Favours PBO
Overall population +
<65y +
65-74 y =
275y =>
ol 10
HR (95% Cl)
040 (022-051)
037 (024-055)
0.43 (030-061)
0.40 (0.25-0.64)
Time to Deterioration in FACT-P Total Score
Favgurs Daro Favours PBO
Overall population sal
<85y i
65-74 y |
275 +
oï o
HR (95% Ci)
076 (061-034)
070 (047-105)
076 (055-105)
081(0.55-119)
70
Copyright © 2010-2025, Peer
ARANOTE Post-Hoc: Efficacy Outcomes
rPFS
Favgurs Dero Favours PEO HR(S5%0)
Overall population rar 054 (01-071)
68 y 0.44(027-0.71)
65-74 y 064 (042-028)
275y 051 (031-084)
où 0
Time to PSA Progression
Favgurs Doro — Favours PBO HR(OSKCH
Overall population —+— 0.31(0.23-0.41)
«sy — 028 (017-046)
65-74y == 031(0.20-0.48)
275y — 033 (018-058)
or 10 0
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Time to mCRPC
Fovgurs Daro Favours PBO
Overall population +
<65y +
65-74 y =
275y =>
ol 10
HR (95% Cl)
040 (022-051)
037 (024-055)
0.43 (030-061)
0.40 (0.25-0.64)
Time to Deterioration in FACT-P Total Score
Favgurs Daro Favours PBO
Overall population sal
<85y i
65-74 y |
275 +
oï o
HR (95% Ci)
076 (061-034)
070 (047-105)
076 (055-105)
081(0.55-119)
70
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ARANOTE Post-Hoc: Safety Outcomes
Age <65 Y Age 65-74 Y
TEAE, % Daro PBO Daro PBO
(Q (n=64) (n=193) (n= 95)
Any 906 844 891 916 941 93.5
Grade 1-2 56.4 547 570 568 526 50.0
Grade 3-4 325 297 280 284 333 33.9
Grade 5 7 o 41 63 81 97
Serious 179 156 228 274 296 258
ee 51 47 57 10.5 74 13
Two patients randomised to placebo group but received Daro were analysed in Daro group for safety analysis set.
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ARANOTE Post-Hoc: Safety Outcomes
Age <65 Y Age 65-74 Y
TEAE, % Daro PBO Daro PBO
(Q (n=64) (n=193) (n= 95)
Any 906 844 891 916 941 93.5
Grade 1-2 56.4 547 570 568 526 50.0
Grade 3-4 325 297 280 284 333 33.9
Grade 5 7 o 41 63 81 97
Serious 179 156 228 274 296 258
ee 51 47 57 10.5 74 13
Two patients randomised to placebo group but received Daro were analysed in Daro group for safety analysis set.
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ARAMIS: Study Designs
Estimating Median OS to Inform the ESMO-MCBS Scores in nmCRPC Using ARAMIS Study
Study Design ARAMIS SPARTAN PROSPER en ARAMIS SPARTAN PROSPER
A Phase 3, multinational, randomised, DB,
Ma PBO-controlled in nmCRPC Primary = = |
nen Darolutamide | Apalutamide | Enzalutamide | | endpoint
8 600 mg BD | 240 mg/d 160 mg/d os os
Randomisati N=1509 N=1207 N = 1401 Time to first PFS os
(ara | Daro APAn Enza n = 933 skeletalevent | Timeto | psa
= PBOn PBO PBOn=468 | |scondery | Timetopain | symptomatic | 5,
TES ondary progression | progression | Progressi
eee 9 203 185 Bl Time to a | Meee
Ces initiation of | initiation of | POLOS
Crossover? Yes Yes Yes cytotoxic CAT | cytotoxic ChT | ¿Se
Background QoL QoL ey
ieee Yes Yes Yes Safety
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ARAMIS: Study Designs
Estimating Median OS to Inform the ESMO-MCBS Scores in nmCRPC Using ARAMIS Study
Study Design ARAMIS SPARTAN PROSPER en ARAMIS SPARTAN PROSPER
A Phase 3, multinational, randomised, DB,
Ma PBO-controlled in nmCRPC Primary = = |
nen Darolutamide | Apalutamide | Enzalutamide | | endpoint
8 600 mg BD | 240 mg/d 160 mg/d os os
Randomisati N=1509 N=1207 N = 1401 Time to first PFS os
(ara | Daro APAn Enza n = 933 skeletalevent | Timeto | psa
= PBOn PBO PBOn=468 | |scondery | Timetopain | symptomatic | 5,
TES ondary progression | progression | Progressi
eee 9 203 185 Bl Time to a | Meee
Ces initiation of | initiation of | POLOS
Crossover? Yes Yes Yes cytotoxic CAT | cytotoxic ChT | ¿Se
Background QoL QoL ey
ieee Yes Yes Yes Safety
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ARAMIS: Efficacy O
os Probability of Survival in ARAMIS
— Generalised Gamma (Doro + ADT)
— DaroKeplan-Meier
— Weibull (PO + ADT)
— PBO Kaplan-Meier
OS Probabil
Probability of Survival
025 | — Darolutamide (n = 955)
— Placebo (n = 554)
CE RBHDMARHH UME EO 5557777 2
Time, mo Time, mo
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ARAMIS: Efficacy O
os Probability of Survival in ARAMIS
— Generalised Gamma (Doro + ADT)
— DaroKeplan-Meier
— Weibull (PO + ADT)
— PBO Kaplan-Meier
OS Probabil
Probability of Survival
025 | — Darolutamide (n = 955)
— Placebo (n = 554)
CE RBHDMARHH UME EO 5557777 2
Time, mo Time, mo
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PSMAddition: Study Design
Phase 3
nt population
+ Eligible patients with
untreated or minimally treated A "ILu-PSMA-617
mHSPC 7.4 GBq + 10%; 6 c
+ ECOG PS 0-2 Q6W) 3
+ 21PSMA+ metastatic lesion on + ADT + ARPI
SGa-PSMA-TIPETCT Safety
+ Appropriate for ADT + ARPI (RIT 1P FS, 3 and OS
‘tioned | follow-up,
Stratification T pen Re
* Disease volume (high/low) per con
CHAARTED criteria ADT + ARPI en.
+ Age 270 y (Y/N)
+ Previous or planned treatment
of primary tumour by radiation
or prostatectomy (Y/N)
Follow-up Periods
+ rPFS: Until event in all patients
+ Safety: 30 d then 24 and 48 wk
after treatment discontinuation
+ OS: Every 90 d after last contact
Minimally treated: ADT in the (neo)adjuvant setting and/or up to 45 d of ADT/ARPI for metastatic disease was allowed before study entry. For treatment
arm ARPI, any ARPI was allowed with one switch allowed. ADT/ARPI not mandatory after crossover.
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erVeice
PSMAddition: Study Design
Phase 3
nt population
+ Eligible patients with
untreated or minimally treated A "ILu-PSMA-617
mHSPC 7.4 GBq + 10%; 6 c
+ ECOG PS 0-2 Q6W) 3
+ 21PSMA+ metastatic lesion on + ADT + ARPI
SGa-PSMA-TIPETCT Safety
+ Appropriate for ADT + ARPI (RIT 1P FS, 3 and OS
‘tioned | follow-up,
Stratification T pen Re
* Disease volume (high/low) per con
CHAARTED criteria ADT + ARPI en.
+ Age 270 y (Y/N)
+ Previous or planned treatment
of primary tumour by radiation
or prostatectomy (Y/N)
Follow-up Periods
+ rPFS: Until event in all patients
+ Safety: 30 d then 24 and 48 wk
after treatment discontinuation
+ OS: Every 90 d after last contact
Minimally treated: ADT in the (neo)adjuvant setting and/or up to 45 d of ADT/ARPI for metastatic disease was allowed before study entry. For treatment
arm ARPI, any ARPI was allowed with one switch allowed. ADT/ARPI not mandatory after crossover.
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erVeice
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PSMAddition: Baseline Patient and Disease Characteristics
ADT + ARPI
+ ADT + ARPI (n = 572) (n= 572)
Median age, y (range) 68.0 (38-91) 68.0 (36-90) 68.0 (36-91)
270 y, % 43.0 43.0 43.0
ECOG PS, %
o 694 72 703
1 30.4 271 28.8
2 02 12 07
Disease site, %
Soft tissue 598 591 594
Bone 913 911 912
Visceral 393 416 40.5
Median PSA level
J 12.06 (316-53.24) 1.64 (2.83-44,1 1191 (3.01-50.34)
ng/ml (IQR) 12.06 (3.16-53.24) 64 (2.83-44.15) .91(3.01-50.34)
Gleason score 8-10
(grade group 4-5), % ceo us ses
High tumour volume, % 68.0 68.2 681
De novo mHSPC, % 521 479 50.0
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PSMAddition: Baseline Patient and Disease Characteristics
ADT + ARPI
+ ADT + ARPI (n = 572) (n= 572)
Median age, y (range) 68.0 (38-91) 68.0 (36-90) 68.0 (36-91)
270 y, % 43.0 43.0 43.0
ECOG PS, %
o 694 72 703
1 30.4 271 28.8
2 02 12 07
Disease site, %
Soft tissue 598 591 594
Bone 913 911 912
Visceral 393 416 40.5
Median PSA level
J 12.06 (316-53.24) 1.64 (2.83-44,1 1191 (3.01-50.34)
ng/ml (IQR) 12.06 (3.16-53.24) 64 (2.83-44.15) .91(3.01-50.34)
Gleason score 8-10
(grade group 4-5), % ceo us ses
High tumour volume, % 68.0 68.2 681
De novo mHSPC, % 521 479 50.0
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100
—— "Lu-PSMA-617 + ADT + ARPI (n = 572)
—— ADT + ARPI(n = 572)
80
60
Median rPFS, mo
7Lu-PSMA-617 + ADT + ARPI, NR
ADT + ARPI, NR
HR, 0.72 (95% CI, 0.58-0.90); P = .002
Event-Free Probability, %
O 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42
Time From Randomisation, mo
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100
—— "Lu-PSMA-617 + ADT + ARPI (n = 572)
—— ADT + ARPI(n = 572)
80
60
Median rPFS, mo
7Lu-PSMA-617 + ADT + ARPI, NR
ADT + ARPI, NR
HR, 0.72 (95% CI, 0.58-0.90); P = .002
Event-Free Probability, %
O 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42
Time From Randomisation, mo
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PSMAddition: Interim OS
HR, 0.84 (95% Cl, 0.63-1.13); P = 125
à 100 —— "Lu-PSMA-617 + ADT + ARPI(n = 572)
> —— ADT + ARPI(n = 572)
FA
= 80
2
E
e © Median OS, mo
a ie 77Lu-PSMA-617 + ADT + ARPI, NR
$ ADT + ARPI, NR
[re
0
L
|]
fo]
>
w
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44
Time From Randomisation, mo
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PSMAddition: Interim OS
HR, 0.84 (95% Cl, 0.63-1.13); P = 125
à 100 —— "Lu-PSMA-617 + ADT + ARPI(n = 572)
> —— ADT + ARPI(n = 572)
FA
= 80
2
E
e © Median OS, mo
a ie 77Lu-PSMA-617 + ADT + ARPI, NR
$ ADT + ARPI, NR
[re
0
L
|]
fo]
>
w
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44
Time From Randomisation, mo
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PeerVoice
PSMAddition: Safety Outcomes
5 Tiu-PSMA-GT7 ADTs API
[AEs in 210% of Pationts in +ADT + ARPI(n= 664) (o= 868)
WLU-PSMA-6T7 Arm, % - -
Any Grade | Grade) | AnyGrade | Grade:
Dry mouth 457 o 37 o
Fatigue EN] u 280 m
auto. 242 02 EJ o
Hot fush 201 o 263 a
Ansemis, EJ so "3 27
‘arth 197 os 230 15
Back pain ma 14 195 28
Constipation ms o EI a
Astnenia 163 04 EX] 09
Decressed eppatite ma os ES 02
Vomiting ms 97 37 o
CITE En 08 108 04
Hypertension ES so 168 62
Diammoco 22 02 EN a
Heodache m2 o 20 04
ALT increased m sa ne 25
Dysgousi 19 o EI a
Wiite blood cel count decreased m EI 37 68
‘ASTincroased 108 18 ns 19
Lymphocyte count decreased 108 50 Ed 2
Dry mouth: Grade 1 in 410% and grade 2 in 4.8% in V’Lu-PSMA-617+ ADT + ARPI arm; grade 1 in 3.4% and grade 2 in 0.4% in ADT + ARPI arm.
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PSMAddition: Safety Outcomes
5 Tiu-PSMA-GT7 ADTs API
[AEs in 210% of Pationts in +ADT + ARPI(n= 664) (o= 868)
WLU-PSMA-6T7 Arm, % - -
Any Grade | Grade) | AnyGrade | Grade:
Dry mouth 457 o 37 o
Fatigue EN] u 280 m
auto. 242 02 EJ o
Hot fush 201 o 263 a
Ansemis, EJ so "3 27
‘arth 197 os 230 15
Back pain ma 14 195 28
Constipation ms o EI a
Astnenia 163 04 EX] 09
Decressed eppatite ma os ES 02
Vomiting ms 97 37 o
CITE En 08 108 04
Hypertension ES so 168 62
Diammoco 22 02 EN a
Heodache m2 o 20 04
ALT increased m sa ne 25
Dysgousi 19 o EI a
Wiite blood cel count decreased m EI 37 68
‘ASTincroased 108 18 ns 19
Lymphocyte count decreased 108 50 Ed 2
Dry mouth: Grade 1 in 410% and grade 2 in 4.8% in V’Lu-PSMA-617+ ADT + ARPI arm; grade 1 in 3.4% and grade 2 in 0.4% in ADT + ARPI arm.
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Abbreviations and References
ARASAFE: Study Design
Abbreviation(s): ADT: androgen deprivation therapy; AE: adverse event; ALP: alkaline phosphatase; BID: twice daily;
CRPC: castration-resistant prostate cancer; ECOG PS: Eastern Cooperative Oncology Group Performance Status;
EXP: experimental arm; FPFV: first patient, first visit; LPFV: last patient, first visit; mHSPC: metastatic hormone-sen
prostate cancer; OS: overall survival; Q2/3W: every 2/3 weeks; QOL: quality of life; SSE: symptomatic skeletal event;
STD: standard arm; ULN: upper limit of normal.
Reference(s): Grimm M-O et al. European Society for Medical Oncology Congress 2025 (ESMO Congress 2025).
Abstract LBA92
ARASAFE: Baseline Patient and Disease Characteristics
Abbreviation(s): PSA: prostate-specific antigen.
Reference(s): Grimm M-O et al. ESMO Congress 2025. Abstract LBA92.
ARASAFE: Primary Endpoints
Reference(s): Grimm M-O et al. ESMO Congress 2025. Abstract LBA92.
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Abbreviations and References
ARASAFE: Study Design
Abbreviation(s): ADT: androgen deprivation therapy; AE: adverse event; ALP: alkaline phosphatase; BID: twice daily;
CRPC: castration-resistant prostate cancer; ECOG PS: Eastern Cooperative Oncology Group Performance Status;
EXP: experimental arm; FPFV: first patient, first visit; LPFV: last patient, first visit; mHSPC: metastatic hormone-sen
prostate cancer; OS: overall survival; Q2/3W: every 2/3 weeks; QOL: quality of life; SSE: symptomatic skeletal event;
STD: standard arm; ULN: upper limit of normal.
Reference(s): Grimm M-O et al. European Society for Medical Oncology Congress 2025 (ESMO Congress 2025).
Abstract LBA92
ARASAFE: Baseline Patient and Disease Characteristics
Abbreviation(s): PSA: prostate-specific antigen.
Reference(s): Grimm M-O et al. ESMO Congress 2025. Abstract LBA92.
ARASAFE: Primary Endpoints
Reference(s): Grimm M-O et al. ESMO Congress 2025. Abstract LBA92.
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Abbreviations and References (Cont'd)
ARASAFE: Safety Outcomes
Abbreviation(s): ALT: alanine aminotransferase; AST: aspartate aminotransferase; TEAE: treatment-emergent AE.
Reference(s): Grimm M-O et al. ESMO Congress 2025. Abstract LBA92.
ARANOTE Post-Hoc: Study Design
Abbreviation(s): mCRPC: metastatic CRPC; FACT-P: Functional Assessment of Cancer Therapy - Prostate;
rPFS: radiological progression-free survival.
Reference(s): Saad F et al. ESMO Congress 2025. Abstract 2459P.
ARANOTE Post-Hoc: Efficacy Outcomes
Abbreviation(s): Daro: darolutamide; PBO: placebo.
Reference(s): Saad F et al. ESMO Congress 2025. Abstract 2459P.
ARANOTE Post-Hoc: Safety Outcomes
Reference(s): Saad F et al. ESMO Congress 2025. Abstract 2459P.
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Abbreviations and References (Cont'd)
ARASAFE: Safety Outcomes
Abbreviation(s): ALT: alanine aminotransferase; AST: aspartate aminotransferase; TEAE: treatment-emergent AE.
Reference(s): Grimm M-O et al. ESMO Congress 2025. Abstract LBA92.
ARANOTE Post-Hoc: Study Design
Abbreviation(s): mCRPC: metastatic CRPC; FACT-P: Functional Assessment of Cancer Therapy - Prostate;
rPFS: radiological progression-free survival.
Reference(s): Saad F et al. ESMO Congress 2025. Abstract 2459P.
ARANOTE Post-Hoc: Efficacy Outcomes
Abbreviation(s): Daro: darolutamide; PBO: placebo.
Reference(s): Saad F et al. ESMO Congress 2025. Abstract 2459P.
ARANOTE Post-Hoc: Safety Outcomes
Reference(s): Saad F et al. ESMO Congress 2025. Abstract 2459P.
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Abbreviations and References (Cont'd)
ARAMIS: Study Designs
Abbreviation(s): APA: apalutamide; ChT: chemotherapy; Enza: enzalutamide; ESMO-MCBS: European Society for Medical
Oncology-Magnitude of Clinical Benefit Scale; MFS: metastasis-free survival; nmCRPC: non-metastatic CRPC.
Reference(s): Boegemann M et al. ESMO Congress 2025. Abstract 2522eP.
ARAMIS: Efficacy Outcomes
Reference(s): Boegemann M et al. ESMO Congress 2025. Abstract 2522eP.
PSMAddition: Study Design
Abbreviation(s): ARPI: androgen receptor pathway inhibitor; BIRC: Blinded Independent Review Committee; Lu: lutetium;
PSMA: prostate-specific membrane antigen; Q6W: every 6 weeks.
Reference(s): Tagawa ST et al. ESMO Congress 2025. Abstract LBA6.
PSMAddition: Baseline Patient and Disease Characteristics
Reference(s): Tagawa ST et al. ESMO Congress 2025. Abstract LBAG.
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Abbreviations and References (Cont'd)
ARAMIS: Study Designs
Abbreviation(s): APA: apalutamide; ChT: chemotherapy; Enza: enzalutamide; ESMO-MCBS: European Society for Medical
Oncology-Magnitude of Clinical Benefit Scale; MFS: metastasis-free survival; nmCRPC: non-metastatic CRPC.
Reference(s): Boegemann M et al. ESMO Congress 2025. Abstract 2522eP.
ARAMIS: Efficacy Outcomes
Reference(s): Boegemann M et al. ESMO Congress 2025. Abstract 2522eP.
PSMAddition: Study Design
Abbreviation(s): ARPI: androgen receptor pathway inhibitor; BIRC: Blinded Independent Review Committee; Lu: lutetium;
PSMA: prostate-specific membrane antigen; Q6W: every 6 weeks.
Reference(s): Tagawa ST et al. ESMO Congress 2025. Abstract LBA6.
PSMAddition: Baseline Patient and Disease Characteristics
Reference(s): Tagawa ST et al. ESMO Congress 2025. Abstract LBAG.
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Abbreviations and References (Cont'd)
PSMAddition: rPFS by BIRC
Abbreviation(s): NR: not reached.
Reference(s): Tagawa ST et al. ESMO Congress 2025. Abstract LBAS.
PSMAddition: Interim OS
Reference(s): Tagawa ST et al, ESMO Congress 2025. Abstract LBA6.
PSMAddition: Safety Outcomes
Reference(s): Tagawa ST et al. ESMO Congress 2025. Abstract LBAS.
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Abbreviations and References (Cont'd)
PSMAddition: rPFS by BIRC
Abbreviation(s): NR: not reached.
Reference(s): Tagawa ST et al. ESMO Congress 2025. Abstract LBAS.
PSMAddition: Interim OS
Reference(s): Tagawa ST et al, ESMO Congress 2025. Abstract LBA6.
PSMAddition: Safety Outcomes
Reference(s): Tagawa ST et al. ESMO Congress 2025. Abstract LBAS.
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Part 2 of 2: Perspectives on Progress: Reflecting on the Relevance of
Recent Data From ESMO 2025 in mHSPC and nmCRPC
Fred Saad, MD, FRCS
Professor of Surgery/Urology
University of Montreal
Chairman of Surgery
University of Montreal Hospital Center
Montreal, Quebec, Canada
Alicia K. Morgans, MD, MPH
Associate Professor
Harvard Medical School
Director, Adult Survivorship
Dana-Farber Cancer Institute
Boston, Massachusetts, USA
Copyright © 2010-2025, Poervoi
Part 2 of 2: Perspectives on Progress: Reflecting on the Relevance of
Recent Data From ESMO 2025 in mHSPC and nmCRPC
Fred Saad, MD, FRCS
Professor of Surgery/Urology
University of Montreal
Chairman of Surgery
University of Montreal Hospital Center
Montreal, Quebec, Canada
Alicia K. Morgans, MD, MPH
Associate Professor
Harvard Medical School
Director, Adult Survivorship
Dana-Farber Cancer Institute
Boston, Massachusetts, USA
Copyright © 2010-2025, Poervoi
PeerVoice
Fred Saad, MD, FRCS, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc.; AstraZeneca; Bayer AG; Bristol Myers Squibb Company;
GSK plc; Janssen Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc; Sumitomo Pharma Co, Lt
TerSera Therapeutics LLC; and Tolmar Inc.
Grant/Research Support from Astellas Pharma Inc; AstraZeneca; Bayer AG; Bristol Myers Squibb
Company; GSK ple; Janssen Inc.; Merck & Co, Inc.; Novartis AG; and Pfizer Inc.
Advisory Board for Astellas Pharma Inc.; AstraZeneca; Bayer AG; Bristol Myers Squibb Company;
GSK ple; Janssen Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc.; Sumitomo Pharma Co, Ltd;
TerSera Therapeutics LLC; and Tolmar Inc.
Speaker or participant in accredited CME/CPD for Astellas Pharma Inc.; AstraZeneca; Bayer AG;
Bristol Myers Squibb Company; GSK ple Janssen Inc. Merck & Co, Inc.; Novartis AG; Pfizer Inc;
Sumitomo Pharma Co, Ltd; TerSera Therapeutics LLC; and Tolmar Inc.
Alicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc; AstraZeneca; Bayer AG; Curium; Dendreon Pharmaceuticals
LLC; Exelixis, Inc; Lantheus; MacroGenics, Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc.; Telix
Pharmaceuticals Ltd; and Tolmar Inc.
Grant/Research Support from Astellas Pharma Inc; Bayer AG; Bristol Myers Squibb Company;
Exact Sciences Corp; Lantheus; Novartis AG; Pfizer Inc.; and Sumitomo Pharma Co, Ltd.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
Fred Saad, MD, FRCS, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc.; AstraZeneca; Bayer AG; Bristol Myers Squibb Company;
GSK plc; Janssen Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc; Sumitomo Pharma Co, Lt
TerSera Therapeutics LLC; and Tolmar Inc.
Grant/Research Support from Astellas Pharma Inc; AstraZeneca; Bayer AG; Bristol Myers Squibb
Company; GSK ple; Janssen Inc.; Merck & Co, Inc.; Novartis AG; and Pfizer Inc.
Advisory Board for Astellas Pharma Inc.; AstraZeneca; Bayer AG; Bristol Myers Squibb Company;
GSK ple; Janssen Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc.; Sumitomo Pharma Co, Ltd;
TerSera Therapeutics LLC; and Tolmar Inc.
Speaker or participant in accredited CME/CPD for Astellas Pharma Inc.; AstraZeneca; Bayer AG;
Bristol Myers Squibb Company; GSK ple Janssen Inc. Merck & Co, Inc.; Novartis AG; Pfizer Inc;
Sumitomo Pharma Co, Ltd; TerSera Therapeutics LLC; and Tolmar Inc.
Alicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:
Consultant for Astellas Pharma Inc; AstraZeneca; Bayer AG; Curium; Dendreon Pharmaceuticals
LLC; Exelixis, Inc; Lantheus; MacroGenics, Inc.; Merck & Co, Inc.; Novartis AG; Pfizer Inc.; Telix
Pharmaceuticals Ltd; and Tolmar Inc.
Grant/Research Support from Astellas Pharma Inc; Bayer AG; Bristol Myers Squibb Company;
Exact Sciences Corp; Lantheus; Novartis AG; Pfizer Inc.; and Sumitomo Pharma Co, Ltd.
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ARAAT: Study Design
26 mo of EUR 26 mo of EMR
activity activity
unless newly unless patient
diagnosed Retrospective cohort chart review analysis died
of patients with mHSPC
BL period
k hi ‘Outcome assessment 2
Index date:
July Darolutamide or abiraterone
2019 initiated + ADT + docetaxel for mHSPC
Study period
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Categorisation
* Low baseline PSA group
(Quartile 1): <7.83 ng/mL
+ High baseline PSA group
(Quartile 2-Quartile 4):
>7.83 ng/mL
Endpoints
+ PSA <0.2 ng/ml and time to
reach PSA <0.2 ng/mL.
* Correlation between PSA
response and time to
mCRPC (darolutamide
cohort only)
+ Time to reach PSA <0.2
ng/mL stratified by baseline
PSA group/cohort
+ Time to mCRPC strati
by baseline PSA
group/cohort
fied
Copyright © 2010-2025, PeerVoice
ARAAT: Study Design
26 mo of EUR 26 mo of EMR
activity activity
unless newly unless patient
diagnosed Retrospective cohort chart review analysis died
of patients with mHSPC
BL period
k hi ‘Outcome assessment 2
Index date:
July Darolutamide or abiraterone
2019 initiated + ADT + docetaxel for mHSPC
Study period
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Categorisation
* Low baseline PSA group
(Quartile 1): <7.83 ng/mL
+ High baseline PSA group
(Quartile 2-Quartile 4):
>7.83 ng/mL
Endpoints
+ PSA <0.2 ng/ml and time to
reach PSA <0.2 ng/mL.
* Correlation between PSA
response and time to
mCRPC (darolutamide
cohort only)
+ Time to reach PSA <0.2
ng/mL stratified by baseline
PSA group/cohort
+ Time to mCRPC strati
by baseline PSA
group/cohort
fied
Copyright © 2010-2025, PeerVoice
PeerVoice
ARAAT: Time to Reach PSA <0.2
g/mL by Baseline PSA
Low BL PSA (<7.83 ng/mL)
— Darolutamide (n = 16)
— Abiraterone (n = 14)
of PSA <0.2 ng/mL
Daro, 3.0 mo
6 2 E % +
Time, mo
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y of PSA <0.2 ng/mL
High BL PSA (>7.83 ng/mL)
~ Abi, 15.4 mo
Time, mo
Copyright © 2010-2025, PeerVoice
ARAAT: Time to Reach PSA <0.2
g/mL by Baseline PSA
Low BL PSA (<7.83 ng/mL)
— Darolutamide (n = 16)
— Abiraterone (n = 14)
of PSA <0.2 ng/mL
Daro, 3.0 mo
6 2 E % +
Time, mo
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y of PSA <0.2 ng/mL
High BL PSA (>7.83 ng/mL)
~ Abi, 15.4 mo
Time, mo
Copyright © 2010-2025, PeerVoice
PeerVoice
ARAAT: Time to mCRPC by Baseline PSA
Low BL PSA (<7.83 ng/mL) High BL PSA (>7.83 ng/mL)
a © Daro, NR ye
Z os Dos
2 07 Sor
5 E Dora a
5 06 Eos
Bos Ss
3 04 Boa
El 03 ADL197mo Bas Abi, 19.6 mo
& 92] —Darolutamide (n = 20) É 024 —Darolutamide (n = 91)
9-1] —Abiraterone (n = 28) a1] —Abiraterone (n= 44)
o
à sl a 3 a a) si e ° o 6 12 18 24 EJ 36 42
Time, mo
Time, mo
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ARAAT: Time to mCRPC by Baseline PSA
Low BL PSA (<7.83 ng/mL) High BL PSA (>7.83 ng/mL)
a © Daro, NR ye
Z os Dos
2 07 Sor
5 E Dora a
5 06 Eos
Bos Ss
3 04 Boa
El 03 ADL197mo Bas Abi, 19.6 mo
& 92] —Darolutamide (n = 20) É 024 —Darolutamide (n = 91)
9-1] —Abiraterone (n = 28) a1] —Abiraterone (n= 44)
o
à sl a 3 a a) si e ° o 6 12 18 24 EJ 36 42
Time, mo
Time, mo
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PeerVoice
ARAAT: Time to Reach PSA <0.2 ng/mL in Overall Population
Overall Time to Reach PSA <0.2 ng/mL Patients Achieving PSA <0.2 ng/mL
mabi(n=57) m Daro (n = 103)
At any time
At 12 months.
Abi, 9.5 mo
At 9 months.
Probability of PSA «0.2 ng/ml
02
— Darolutamice (n = 103) Dore, 64 mo Fa
91] —Abiraterone (n = 57) At 6 mont
o
oo 2 mn a a E à
% 0 0 2 x 4 6 © m
Time, mo
Patients, %
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ARAAT: Time to Reach PSA <0.2 ng/mL in Overall Population
Overall Time to Reach PSA <0.2 ng/mL Patients Achieving PSA <0.2 ng/mL
mabi(n=57) m Daro (n = 103)
At any time
At 12 months.
Abi, 9.5 mo
At 9 months.
Probability of PSA «0.2 ng/ml
02
— Darolutamice (n = 103) Dore, 64 mo Fa
91] —Abiraterone (n = 57) At 6 mont
o
oo 2 mn a a E à
% 0 0 2 x 4 6 © m
Time, mo
Patients, %
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PeerVoice
DAROL: Study Design
Eligibility
+ Confirmed nmCRPC
+ Disease
progression
despite ADT
+ No evidence of
mets on
conventional
imaging
+ Decision to initiate
darolutamide before
enrolment
Darolutamide 6(
0 mg BID*
FPFV: 30 Jan 2020
LPFV: 7 July 2023
Prespecified =
m 12 aa CHIEN
Planned
pe 100 | -300 | -s00 || -s00 || -800
Treatment
Are | 26mo | 26mo | 26mo || 212mo || 236mo
Data
cutoff
for lA4
8 July
2024
Primary endpoint
Secondary/exploratory
endpoints
Safety
Efficacy: OS, MFS,
time to mCRPC, PSA
response, time to
undetectable PSA,
time to PSA
progression
HRQOL
‘Ongoing global, prospective, open-label, single-arm, noninterventional DAROL designed to support ARAMIS by assessing safety and efficacy of
darolutamide in patients with nmCRPC in real-world conditions.
* Treatment is according to investigator's routine clinical practice, based on recommendations in local production information.
** Unless patient discontinued treatment earlier.
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Copyright © 2010-2025,
erVeice
DAROL: Study Design
Eligibility
+ Confirmed nmCRPC
+ Disease
progression
despite ADT
+ No evidence of
mets on
conventional
imaging
+ Decision to initiate
darolutamide before
enrolment
Darolutamide 6(
0 mg BID*
FPFV: 30 Jan 2020
LPFV: 7 July 2023
Prespecified =
m 12 aa CHIEN
Planned
pe 100 | -300 | -s00 || -s00 || -800
Treatment
Are | 26mo | 26mo | 26mo || 212mo || 236mo
Data
cutoff
for lA4
8 July
2024
Primary endpoint
Secondary/exploratory
endpoints
Safety
Efficacy: OS, MFS,
time to mCRPC, PSA
response, time to
undetectable PSA,
time to PSA
progression
HRQOL
‘Ongoing global, prospective, open-label, single-arm, noninterventional DAROL designed to support ARAMIS by assessing safety and efficacy of
darolutamide in patients with nmCRPC in real-world conditions.
* Treatment is according to investigator's routine clinical practice, based on recommendations in local production information.
** Unless patient discontinued treatment earlier.
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Copyright © 2010-2025,
erVeice
PeerVoice
DAROL: Safety
DAROLIAA
DAROL IA4 ARAMIS =
Patients, %
2
3
24.8%
19.0%
8.8% 8.9%
o = |
Any Serious Leading to Daro Any Serious Leading to Daro
discontinuation discontinuation
Median follow-up in DAROL 1A4, 22.5 mo (IQR, 16.4-29.7) ad median treatment duration, 18.0 mo (IQR, 10.9-26.2). In comparison, median follow-up and
treatment duration in ARAMIS (primary analysis cutoff) were 17.9 mo and 14.8 mo, respectively. TEAEs include all events, including those not deemed by
investigator to be related to darolutamide. Safety analysis set includes all patients enrolled in study who had taken 21 dose of darolutamide and
completed 212 mo of treatment or discontinued treatment.
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Copyright © 2010-2025, Peer
DAROL: Safety
DAROLIAA
DAROL IA4 ARAMIS =
Patients, %
2
3
24.8%
19.0%
8.8% 8.9%
o = |
Any Serious Leading to Daro Any Serious Leading to Daro
discontinuation discontinuation
Median follow-up in DAROL 1A4, 22.5 mo (IQR, 16.4-29.7) ad median treatment duration, 18.0 mo (IQR, 10.9-26.2). In comparison, median follow-up and
treatment duration in ARAMIS (primary analysis cutoff) were 17.9 mo and 14.8 mo, respectively. TEAEs include all events, including those not deemed by
investigator to be related to darolutamide. Safety analysis set includes all patients enrolled in study who had taken 21 dose of darolutamide and
completed 212 mo of treatment or discontinued treatment.
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PeerVoice
DAROL: Efficacy
DAROL IA4 Landmark Survival Rates PSA Response at Any Time
len m m m i
a a Bes we 5
o 5 >
és i
so
¥ 60 g 509
É 40 zo
= "
| °
E Cm PAM ee
en
MDAROL IAA mARAMIS.
6mo mly m2y
Full analysis set includes patients who received 21 dose of darolutamide, met all eligibility criteria, and had 21 post-BL follow-up visit after receiving
darolutamide. Data indicated for ARAMIS are from the darolutamide group in the primary ARAMIS analysis (n = 955), data cutoff 3 September 2018.
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Copyright © 2010-2025, Peer
DAROL: Efficacy
DAROL IA4 Landmark Survival Rates PSA Response at Any Time
len m m m i
a a Bes we 5
o 5 >
és i
so
¥ 60 g 509
É 40 zo
= "
| °
E Cm PAM ee
en
MDAROL IAA mARAMIS.
6mo mly m2y
Full analysis set includes patients who received 21 dose of darolutamide, met all eligibility criteria, and had 21 post-BL follow-up visit after receiving
darolutamide. Data indicated for ARAMIS are from the darolutamide group in the primary ARAMIS analysis (n = 955), data cutoff 3 September 2018.
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PeerVoice
Patient Perspectives of Symptom Burden and Impact of HT in
the US and Germany: Study Design
Most patients who completed
survey had local or locoregional
disease (81.2%, median age of 70 y)
Recruitment of patients from US and Germany
[Ey Ciuro Newsletter
10.5% (132) Desktop
20.2% (267)
a) Facebook Ads N=1324
E” 812% (1075) Patients
Eros diagnosed
17.0% (225) th
(Zi) Instagram Ads prostate
HE 7.6% (101) = dancer n= 400
628% (832) Recelving
Other Source ongoing HT
12% (16)
Patients in the US and Germany participated in online survey primarily via social media adverts. Survey included questions on demographics, cancer
characteristics, treatment status, symptoms associated with HT, shared decision-making, and support.
Copyright © 2010-2025, PeerVoice
www.peervoice.com/XKC870
Patient Perspectives of Symptom Burden and Impact of HT in
the US and Germany: Study Design
Most patients who completed
survey had local or locoregional
disease (81.2%, median age of 70 y)
Recruitment of patients from US and Germany
[Ey Ciuro Newsletter
10.5% (132) Desktop
20.2% (267)
a) Facebook Ads N=1324
E” 812% (1075) Patients
Eros diagnosed
17.0% (225) th
(Zi) Instagram Ads prostate
HE 7.6% (101) = dancer n= 400
628% (832) Recelving
Other Source ongoing HT
12% (16)
Patients in the US and Germany participated in online survey primarily via social media adverts. Survey included questions on demographics, cancer
characteristics, treatment status, symptoms associated with HT, shared decision-making, and support.
Copyright © 2010-2025, PeerVoice
www.peervoice.com/XKC870
PeerVoice
Symptom Burden of HT in the USA and Germany: Study Design
Most Bothersome Side
Never HT
Ongoing HT
Effects, % 400)
Impact on sex life 50.2 79.9
nae sy tiredness, 334 68.5
Hot flushes 72) 68.5
een ES ES
Sleep problems 97 23.9
Psychologie distress 26.9 38.8
Other symptoms 47 5.3
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Copyright © 2010-2025, PeerVoice
Symptom Burden of HT in the USA and Germany: Study Design
Most Bothersome Side
Never HT
Ongoing HT
Effects, % 400)
Impact on sex life 50.2 79.9
nae sy tiredness, 334 68.5
Hot flushes 72) 68.5
een ES ES
Sleep problems 97 23.9
Psychologie distress 26.9 38.8
Other symptoms 47 5.3
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Copyright © 2010-2025, PeerVoice
PeerVoice
CAPItello-281: Study Design
Phase 3
Patient population
+ PTEN-deficient de novo mHSPC
+ PTEN deficiency
— Diagnostic cutoff 290% of
speci
by IHC (ie, <10% of cells
expressing PTEN by IHC)
Stratification
visceral mets
+ Geography
N=1012
PTEN deficiency determined using investigational antibody for PTEN (SP218). Stratification factors are MI volume: high-volume disease wi
viable malignant cells with no
cytoplasmic staining
* Mi volume (CHAARTED criteria) and
Placebo 400 mg BID
(a don, 3 d'off)
Abiraterone/Pred
1000 mg/5 mg QD + ADT
Current analysis
+ Primary rPFS data cutoff 7 Oct 2024
+ Median rPFS follow-up, 18 mo
Primary endpoint
+ Investigator-assessed rPFS
Secondary endpoints
+ os
+ Time to first subsequent
therapy
+ Symptomatic skeletal
event-free survival
+ Time to pain progression
+ Time to castration
resistance
+ Time to PSA progression
Exploratory post-hoc PTEN
deficiency subgroups
isceral
mets, high-volume disease without visceral mets, low-volume disease; geography: North America, western Europe and Australia; Latin America, eastern
Europe, and Asia,
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Copyright © 2010-2025, PeerVoice
CAPItello-281: Study Design
Phase 3
Patient population
+ PTEN-deficient de novo mHSPC
+ PTEN deficiency
— Diagnostic cutoff 290% of
speci
by IHC (ie, <10% of cells
expressing PTEN by IHC)
Stratification
visceral mets
+ Geography
N=1012
PTEN deficiency determined using investigational antibody for PTEN (SP218). Stratification factors are MI volume: high-volume disease wi
viable malignant cells with no
cytoplasmic staining
* Mi volume (CHAARTED criteria) and
Placebo 400 mg BID
(a don, 3 d'off)
Abiraterone/Pred
1000 mg/5 mg QD + ADT
Current analysis
+ Primary rPFS data cutoff 7 Oct 2024
+ Median rPFS follow-up, 18 mo
Primary endpoint
+ Investigator-assessed rPFS
Secondary endpoints
+ os
+ Time to first subsequent
therapy
+ Symptomatic skeletal
event-free survival
+ Time to pain progression
+ Time to castration
resistance
+ Time to PSA progression
Exploratory post-hoc PTEN
deficiency subgroups
isceral
mets, high-volume disease without visceral mets, low-volume disease; geography: North America, western Europe and Australia; Latin America, eastern
Europe, and Asia,
www.peervoice.com/XKC870
Copyright © 2010-2025, PeerVoice
PeerVoice
CAPitello-281: Baseline Patient and Disease Characteristics
o 649 634
1 351 366
Metastasen, %
Eone ou 925
iver 59 50
Lung, 136 143
"Nonregional lymph node 428 424
Medion time from diagnosis to randomisation, mo 246 245
Total Gleason score at diagnosis, %
6 185 188
28 785 mo
Disease nk %
High 63 659
Low 363 325
MI volumejviscoral metastases, %
High volume with visceral mets 193 188
High volume without visceral mets 544 360
Low volume, 258 250
Percentage values do not sum to 100% due to data categorised as missing/other/not reported.
www.peervoice.com/XKC870 Copyright © 2010-2025, Peer
CAPitello-281: Baseline Patient and Disease Characteristics
o 649 634
1 351 366
Metastasen, %
Eone ou 925
iver 59 50
Lung, 136 143
"Nonregional lymph node 428 424
Medion time from diagnosis to randomisation, mo 246 245
Total Gleason score at diagnosis, %
6 185 188
28 785 mo
Disease nk %
High 63 659
Low 363 325
MI volumejviscoral metastases, %
High volume with visceral mets 193 188
High volume without visceral mets 544 360
Low volume, 258 250
Percentage values do not sum to 100% due to data categorised as missing/other/not reported.
www.peervoice.com/XKC870 Copyright © 2010-2025, Peer
PeerVoice
CAPItello-281: Investigator-Assessed rPFS
Median rPFS, mo
Capivasertib + Abiraterone, 33.2
Placebo + Abiraterone, 25.7
o
uw 08
= HR, 0.81 (95% Cl, 0.66-0.98); P = 034
o
08
2
À os
8
2 H H
or 25.7 mo | ———*! 33.2 mo
—— Capivasertib + Abiraterone (n = 507) 75mo ı
{Placebo + Abiraterone (n = 505) H
o 3 6 9 BR 6 18 2 24 27 30 38 36 39 42 45
Time From Randomisation, mo
Median follow-up: Capivasertib + abiraterone, 18.4 mo; placebo + abiraterone, 18.5 mo.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
CAPItello-281: Investigator-Assessed rPFS
Median rPFS, mo
Capivasertib + Abiraterone, 33.2
Placebo + Abiraterone, 25.7
o
uw 08
= HR, 0.81 (95% Cl, 0.66-0.98); P = 034
o
08
2
À os
8
2 H H
or 25.7 mo | ———*! 33.2 mo
—— Capivasertib + Abiraterone (n = 507) 75mo ı
{Placebo + Abiraterone (n = 505) H
o 3 6 9 BR 6 18 2 24 27 30 38 36 39 42 45
Time From Randomisation, mo
Median follow-up: Capivasertib + abiraterone, 18.4 mo; placebo + abiraterone, 18.5 mo.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
PeerVoice
CAPitello-281: Safety Profile
Capivasertib +
Abiraterone (n = 503)
Grados | PE
AEs in 10% of Patients
Placebo +
Abiraterone (n = 503)
DEAN ras
Diarrnooo 519/62, 80/04
Hyperslycaomia 380103 129106
ash 354723 70/02
anaemia 239/52 1270
Hypokalaemia 22187 17/48
Hypertension 19/68 239/78
Fatigue 139/08 125108
ALT increase Mas 133/94
Urinary tract infection 137142 woe
AST increase 12926
Nausea mos
17/08
13/08
woona
105/02
105/02
Back pain 99/06
Constipation 83102
Artola 28104
CT 2 00 > e
Total/Grade 3, %
Total/Grade 3, %
Diabetic ketoacidosis reported in 6 patients (12%) in the capivasertib + abiraterone arm, and O patients in the placebo + abiraterone arm.
Grouped terms are shown.
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Copyright © 2010-2025, Peer
CAPitello-281: Safety Profile
Capivasertib +
Abiraterone (n = 503)
Grados | PE
AEs in 10% of Patients
Placebo +
Abiraterone (n = 503)
DEAN ras
Diarrnooo 519/62, 80/04
Hyperslycaomia 380103 129106
ash 354723 70/02
anaemia 239/52 1270
Hypokalaemia 22187 17/48
Hypertension 19/68 239/78
Fatigue 139/08 125108
ALT increase Mas 133/94
Urinary tract infection 137142 woe
AST increase 12926
Nausea mos
17/08
13/08
woona
105/02
105/02
Back pain 99/06
Constipation 83102
Artola 28104
CT 2 00 > e
Total/Grade 3, %
Total/Grade 3, %
Diabetic ketoacidosis reported in 6 patients (12%) in the capivasertib + abiraterone arm, and O patients in the placebo + abiraterone arm.
Grouped terms are shown.
www.peervoice.com/XKC870
Copyright © 2010-2025, Peer
PeerVoice
Abbreviations and References
ARAAT: Study Design
Abbreviation(s): ADT: androgen deprivation therapy; EMR: electronic medical record; mCRPC: metastatic castration-
resistant prostate cancer; mHSPC: metastatic hormone-sensitive prostate cancer; PSA: prostate-specific antigen.
Reference(s): Morgans A et al. European Society for Medical Oncology Congress 2025 (ESMO Congress 2025). Abstract
2477P.
ARAAT: Time to Reach PSA <0.2 ng/mL by Baseline PSA
Abbreviation(s): Abi: abiraterone; BL: baseline; daro: darolutamide,
Reference(s): Morgans A et al. ESMO Congress 2025. Abstract 2477P.
ARAAT: Time to mCRPC by Baseline PSA
Reference(s): Morgans A et al. ESMO Congress 2025. Abstract 2477P.
ARAAT: Time to Reach PSA <0.2 ng/mL in Overall Population
Reference(s): Morgans A et al. ESMO Congress 2025. Abstract 2477P.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
Abbreviations and References
ARAAT: Study Design
Abbreviation(s): ADT: androgen deprivation therapy; EMR: electronic medical record; mCRPC: metastatic castration-
resistant prostate cancer; mHSPC: metastatic hormone-sensitive prostate cancer; PSA: prostate-specific antigen.
Reference(s): Morgans A et al. European Society for Medical Oncology Congress 2025 (ESMO Congress 2025). Abstract
2477P.
ARAAT: Time to Reach PSA <0.2 ng/mL by Baseline PSA
Abbreviation(s): Abi: abiraterone; BL: baseline; daro: darolutamide,
Reference(s): Morgans A et al. ESMO Congress 2025. Abstract 2477P.
ARAAT: Time to mCRPC by Baseline PSA
Reference(s): Morgans A et al. ESMO Congress 2025. Abstract 2477P.
ARAAT: Time to Reach PSA <0.2 ng/mL in Overall Population
Reference(s): Morgans A et al. ESMO Congress 2025. Abstract 2477P.
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PeerVoice
Abbreviations and References (Cont'd)
DAROL: Study Design
Abbreviation(s): BID: 1; FPFV: first patient, first visit; HRQOL: health-related quality of life: IA: interim analysis;
LPFV: last patient, first visit; MFS: metastasis-free survival; nmCRPC: non-metastatic CRPC; OS: overall survival.
Reference(s): De Almeida Luz M et al. ESMO Congress 2025. Abstract 2458P.
DAROL: Safety
Abbreviation(s): ARI: androgen receptor inhibitor; IQR: interquartile range; TEAE: treatment-emergent adverse event.
Reference(s): De Almeida Luz M et al. ESMO Congress 2025. Abstract 2458P.
DAROL: Efficacy
Abbreviation(s): PFS: progression-free survival; PSA50/90: 250%/ 290% reduction in PSA from baseline.
Reference(s): De Almeida Luz M et al. ESMO Congress 2025. Abstract 2458P.
Patient Perspectives of Symptom Burden and Impact of HT in the US and Germany: Study Design
Abbreviation(s): HT: hormone therapy.
Reference(s): Von Amsberg G et al. ESMO Congress 2025. Abstract 2447P.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
Abbreviations and References (Cont'd)
DAROL: Study Design
Abbreviation(s): BID: 1; FPFV: first patient, first visit; HRQOL: health-related quality of life: IA: interim analysis;
LPFV: last patient, first visit; MFS: metastasis-free survival; nmCRPC: non-metastatic CRPC; OS: overall survival.
Reference(s): De Almeida Luz M et al. ESMO Congress 2025. Abstract 2458P.
DAROL: Safety
Abbreviation(s): ARI: androgen receptor inhibitor; IQR: interquartile range; TEAE: treatment-emergent adverse event.
Reference(s): De Almeida Luz M et al. ESMO Congress 2025. Abstract 2458P.
DAROL: Efficacy
Abbreviation(s): PFS: progression-free survival; PSA50/90: 250%/ 290% reduction in PSA from baseline.
Reference(s): De Almeida Luz M et al. ESMO Congress 2025. Abstract 2458P.
Patient Perspectives of Symptom Burden and Impact of HT in the US and Germany: Study Design
Abbreviation(s): HT: hormone therapy.
Reference(s): Von Amsberg G et al. ESMO Congress 2025. Abstract 2447P.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
PeerVoice
Abbreviations and References (Cont'd)
Symptom Burden of HT in the USA and Germany: Study Design
Reference(s): Von Amsberg G et al. ESMO Congress 2025. Abstract 2447P.
CAPitello-281: Study Design
Abbreviation(s): IHC: immunohistochemistry; pred: prednisone; rPFS: radiographic PFS.
Reference(s): Fizazi K et al. ESMO Congress 2025. Abstract 23830.
CAPitello-281: Baseline Patient and Disease Characteristics
Abbreviation(s): ECOG PS: Eastern Cooperative Oncology Group Performance Status.
Reference(s): Fizazi K et al. ESMO Congress 2025. Abstract 23830.
CAPltello-281: Investigator-Assessed rPFS
Reference(s): Fizazi K et al. ESMO Congress 2025. Abstract 23830.
CAPitello-281: Safety Profile
Abbreviation(s): ALT: alanine aminotransferase; AST: aspartate aminotransferase.
Reference(s): Fizazi K et al. ESMO Congress 2025. Abstract 23830.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
Abbreviations and References (Cont'd)
Symptom Burden of HT in the USA and Germany: Study Design
Reference(s): Von Amsberg G et al. ESMO Congress 2025. Abstract 2447P.
CAPitello-281: Study Design
Abbreviation(s): IHC: immunohistochemistry; pred: prednisone; rPFS: radiographic PFS.
Reference(s): Fizazi K et al. ESMO Congress 2025. Abstract 23830.
CAPitello-281: Baseline Patient and Disease Characteristics
Abbreviation(s): ECOG PS: Eastern Cooperative Oncology Group Performance Status.
Reference(s): Fizazi K et al. ESMO Congress 2025. Abstract 23830.
CAPltello-281: Investigator-Assessed rPFS
Reference(s): Fizazi K et al. ESMO Congress 2025. Abstract 23830.
CAPitello-281: Safety Profile
Abbreviation(s): ALT: alanine aminotransferase; AST: aspartate aminotransferase.
Reference(s): Fizazi K et al. ESMO Congress 2025. Abstract 23830.
www.peervoice.com/XKC870 Copyright © 2010-2025, PeerVoice
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