On Target: Understanding the Impact of PSMA for Diagnostic and Therapeutic Strategies in Prostate Cancer

Chair Oliver Sartor, MD, discusses prostate cancer in this CME activity titled “On Target: Understanding the Impact of PSMA for Diagnostic and Therapeutic Strategies in Prostate Cancer.” For the full presentation, downloadable Practice Aids, and complete CME information, and to apply for credit, please visit us at https://bit.ly/49oY4IJ. CME credit will be available until May 23, 2025.

1. On Target
Understanding the Impact of PSMA
for Diagnostic and Therapeutic Strategies
in Prostate Cancer

Oliver Sartor, MD DJ

Professor of Medical Oncology Er
Mayo Clinic >

Rochester, Minnesota y y)

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2. PSMA as an Optimal Target
for Imaging and Therapy

Oliver Sartor, MD

Professor of Medical Oncology
Mayo Clinic

Rochester, Minnesota

Go online to access full CME information, including faculty disclosures.

Copyright © 2000-2024, PeerView

3. Prostate-Specific Membrane Antigen (PSMA)
as a Target for Imaging and Therapy

Radionuclide

Diagnosis Therapy

(eg, gallium-68 (eg, lutetium-177
or F-18) Linker 9 ecinlum-225)
Ligand
PSMA
target

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4. PSMA Is a Transmembrane Protein
Highly Over-Expressed in Prostate Cancer Cells!

C-terminal
(691-750 aa)

Apical region
(117-351 aa)

Extracellular domain

Active site (Zn?*ions) Heros

N-linked sugar moieties ———>,

Proteaselcatalytic domain

(57-116 aa and 352-590 aa) —

Transmembrane region
(19-43 aa)

Cytoplasmic domain
(1-18 aa)
1.9 an ot Br Pham. 2016173001078 PeerView.com

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5. PSMA as a Target for Imaging and Therapy

Small molecules can be linked to radioactive tracers for
imaging or therapeutics

PSMA-PET as a diagnostic tool

Treatment with PSMA-targeting radioligand therapy

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6. 177Lu-PSMA-617 Radioligand Therapy!

7Lu-PSMA-$17 binds to PSMA on
the cell membrane with high affinity

B particle emission

4 rusomor

Prostate cancer cell
and neighboring cell
death

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7. Advances in
PSMA-Targeted Imaging

Oliver Sartor, MD 9 EN
Professor of Medical Oncology MW se
Mayo Clinic S

Rochester, Minnesota y)

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8. Conventional Imaging vs PSMA-PET

Conventional imaging has limitations in detecting prostate
cancer, both in initial staging and for recurrence or spread after

initial primary treatment, including poor detection of early spread
to distant organs

+ PSMA-PET offers the potential for metastatic detection before
standard imaging and can be an informative diagnostic tool to
support treatment plan development

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9. PSMA PET Imaging To Stage Disease or
Select Patients for Therapy’

How do PSMA PET scans differ from current prostate cancer imaging options, such as CT or prostate MRI?

(PSMA PET O) (wo imaging scans of a man who had a prostatectomy
+ Directly targets the tumor on a molecular level to the year before and was found to have a small, but abnormal
show disease more accurately and at an earlier stage | | rise in PSA level
+ Easily outperforms conventional imaging + Afollow-up CT scan showed a normal-appearing, 2 mm
+ CT, MRI, and bone scans cannot match the ability of lymph node (green arrow)
PSMA PET to find very small tumors + APMSAPET scan spotted prostate cancer cells in the tiny

node (blue arrow)

PSMA PET

yoy

=

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10. PSMA PET Imaging To Stage Disease or
Select Patients for Therapy’

7 A

+ 74-year-old with high-risk prostate cancer + Example of local recurrence in a 75-year-old patient
+ Pre-surgical planning 68Ga-PSMA-11 PET/CT presenting with slowly rising PSA after prostatectomy 20
+ Single PSMA avid 2 mm right internal iliac chain years prior
lymph node (white arrow in panels a and d), not well + F18-DCFPyL PET/CT shows focal uptake in the right
seen on CT (white arrow on panel c) ) surgical bed at the anastomosis (white arrows)

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11. PSMA PET Imaging To Stage Disease or
Select Patients for Therapy’

Mona a Abin Rael 202483610382. PeerView.com

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12. PSMA-Targeted PET Imaging Agents

« FDA-approved PSMA PET radiopharmaceutical imaging agents
for patients with localized PSMA-positive disease at initial
staging and at the time of biochemical recurrence

68Ga-PSMA-11 Piflufolastat F-18 Flotufolastat F-18
+ Two prospective clinical + Phase 3 OSPREY and + Phase 3 LIGHTHOUSE and
trials'? CONDOR trials*4 SPOTLIGHT trials®®
+ FDA-approved 2020 + FDA-approved 2021 + FDA-approved 2023

Ge tt JR U 3 eta stg er 10 3 Pam Ka mn a 0
os EIN MTS Eine JO RIOR! € Sas dll ans Uy 70
7 CALLA es cozETOTeR Pau ea

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13. Appropriate Use Criteria for Use of PSMA-PET
Imaging in Prostate Cancer Patients’

Scena

Description Appropriatene:
Patients with suspected prostate cancer (eg, high/rising PSA levels, abnormal digital rectal examination results)

il evaluated with targeted biopsy and detection of intraprostatic tumor Rarely eppropriate
2 Patients with very low, low, and favorable intermediate-risk prostate cancer Rarely appropriate
3 Newly diagnosed unfavorable intermediate, high-risk, or very-high-risk prostate cancer Appropriate

" Nowy dagnaseduntavorabe intermedi ig, or ven-highik prostate cancer wih ngalvelequivocalor appropriate

igometastatic disease on conventional imaging

5 Newly diagnosed prostate cancer with widespread metastatic disease on conventional imaging May be appropriate
6 PSA persistence or PSA rise from undetectable level after radial prostatectomy Appropriate

7 PSA rise above nadir after definitive radiotherapy Appropriate

8 PSA rise after focal therapy of the primary tumor May be appropriate
9 nmCRPC (MO) on conventional imaging Appropriate

46 Eestteetnet FSA ios he mGRPC sting na patent ot being cosida for PEMA AN ra y be appropiate
" Evaluation of eligibility for patients being considered for PSMA-targeted radioligand therapy Appropriate

12 Evaluation of response to th May be appropriate
Y Jose Weta MM 22205048 2 Horn Sta Ab Rade! 2020482603623. PeerView.com

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14. Updates on New and
Emerging PSMA-Targeted

Oliver Sartor, MD

Professor of Medical Oncology
Mayo Clinic

Rochester, Minnesota

Go online to access full CME information, including faculty disclosures.

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15. PSMA-Based Radioligand Therapy!

7Lu-PSMA-617 is now

SOC for mCRPC post-
NHT and taxanes
(phase 3 VISION)

Localized
prostate cancer

mHSPC mCRPC

171Lu-PSMA-617 and
other beta-based RLTs
are moving earlier in

the disease paradigm

3
Fi
ES
A
É
5
E
5
5
E

Hormone sensitive

PSMA-Based RLT Phase 3 Trials: PSMA-DC

PSMAddition PSMAfore VISION
SPLASH
ECLIPSE
1. Ag om P Bt ASCO 202. PeerView.com

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16. Phase 3 VISION:
177Lu-PSMA-617 Plus Best SOC in mCRPC

Key Eligibility Criteria

Previous treatment with both
= =1lendrogen receptor pathway) Protocol-permitted SOC +
foie LA PSMA SAT 2
— 4 or 2taxane regimens 7.4 GBq (200 mCi) every 6 weeks ere .
+ Protocol-permitted SOC planned ble to 6 s [?2| |s Primary
before randomization $8 E endpoint:
= Excluding chemotherapy, =| [E
immunotherapy, radium-233, E 19 2 re bad
investigational drugs Protocol-permitted SOC alone i
+ ECOG performance status 0-2
+ Life expectancy >6 months
PSMA-positive mCRPC on PET/CT CTIMRUbone scans
with ®Ga-PSMA-11

+ Every 8 weeks (treatment)

+ Every 12 weeks (follow-up)
Randomization stratified by + Blinded independent

+ ECOG status (0-1 or 2) central review

+ LDH (high or low)

+ Liver metastases (yes or no)

+ Androgen receptor pathway inhibitors in SOC (yes or no)

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17. 177Lu-PSMA-617 Plus Best SOC
Improved OS and rPFS in mCRPC*S “=

*77Lu-PSMA-617 Improved OS ‘7Lu-PSMA-617 Improved rPFS

> HR = 0.62 (95% Cl, 0.52-0.74); P< 001 (one-sided) 2 ” HR = 0.40 (95% Cl, 0.29-0.57); P< .001 (one-sided)
x Median OS: 15.3 v5 11.3 mo sE” Median (PFS: 8.7 vs 3.4 mo
go óleo
EN ae

ge

a mupsmasi7+ 5% °
Ee SOC (n = 551) ¿5 a "ILu-PSMA-617 +

= à ¡SOC (n = 385)

e SOC (n = 280) ii SOC (n = 196)

Time From Randomization, mo Time From Randomization, mo

+ Both primary endpoints met: improved OS and rPFS in patients receiving 77Lu-PSMA-617 + best SOC compared
with those receiving best SOC alone

+ Higher incidence of TEAEs with 77Lu-PSMA-617 + SOC vs SOC, but treatment exposure was 23 times longer
in the 177Lu-PSMA-617 + SOC arm; exposure-adjusted safety analyses showed comparable findings for both arms

ron ct LAC ASCO Sas ona a à Pa DC sr bn Pron cr Top a ONAN SCT Peel VieW.com

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18. Phase 3 VISION: Secondary Endpoints

PSA Responses Best Overall Responses
= "Lu-PSMA-617 + SOC (n = 184) ‘= SOC alone (n = 64)

s
469 eS

77Lu-PSMA-617 + SOC (n = 333) SOC Alone (n = 138) 40
100 ®
E y
5 Es
“a é
EE 3
¿do ón
as == È
as Sova. E
$£s E
3 EHE v
I»
10
o
Partial "Stable Progressive” Unknown
Response Disease Disease,
ne rare gg ess | PesiVicicom

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19. VISION Safety!

Any AE 519(98.1) 279(527) 170 (829) 78 (8)

47229)

205 (88) 1005)

187(353) 241168)
‘Back pain 124 @34) 1782) 30 (146) 764)
Aral 118223) sam 2027 103)
Decreased appetite 12212) 1019) 30(148) 1005)
Constpated 107 (202) san 2012) 103)
Diarhes 100 (189) 408) ses 1005)
Vomiting 100 (189) 509) 1363) 103)
Trombocytopenia 172) 209 94) 20)
Lymphopenia, 75042) 4103) ses) 1005)
Leukopenia (125) 1985 4@) 1005)
[RE that lod Yo reduction Of LU PSMA DIT dose EX] To) NA NA
AE that led to interruption of "LuPSMAS17 85 (16.1) 209 NA NA
AE that led to discontinuation of "Lu-PSMA-617 9) 37) NA NA

AE that lod to death

Sa ta NE ds 2021385 1094103.

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1986) 1965)

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20. Phase 3 PSMAfore:
177Lu-PSMA-617 in Taxane-Naive mCRPC!

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*7Lu-PSMA-617
7.4 GBq (200 mCi) + 10%

Key Eligibility Criteria

+ Confirmed progressive
mCRPC

+ 21 PSMA-positive metastatic
lesion on [°Ga]Ga-PSMA-11

Stratification

> h i
+ Prior ARPI setting paca %
ne) (castration-resistant Crossover allowed 3
Est à vs hormone- upon radiographic tL
te essed leche sensitive) progression by BICR |
eo + BPISFworstpain hu] "7777700 2
u cone orcas intensity score E
+ Taxane-naive (except (0-3 vs >3)
[neoJadjuvant >12 mo ago)
= Not eligible for a PARPI ARPI change

abiraterone zalutamide

ECOG PS 0-1

+ Primary endpoint: PFS
+ Key secondary endpoint: OS
+ Exploratory endpoints: ORR, DCR, DOR
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21. PSMAfore: Primary Endpoint of rPFS Met!

*Lu-PSMA-617 ARPI Change

(n= 234) (n = 234)

= Events, n (%) 115 (49.1) 168 (71.8)
cy Median rPFS, mo 12.02 5.59

(95% Cl) (930-1442) _(4.17-5.95)

“o

von

Primary HR = 0.41 7Lu-PSMA-617

Event-Free Probability, %

204 (95% Cl, 0.29-0.56); P < .0001 u a
Updated HR = 0.43 (95% CI, 0.33-0.54) a ARPI change
zs 6 6 E 1 ve 1 à» à
Time From Randomization, mo
No, at Risk
24 26 174 150 4125 8 6 45 m 10 2
m 17 mn 65 3% 24 1 8 4 a

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22. PSMAfore: Second Interim OS!

7Lu-PSMA-617 ARPI Change

Prespecified Crossover-Adjusted Analysis (n = 234) (n = 234)
x Median follow-up,
= mo 12.72 13.08
3 MOS, mo 19.25 19.55
3 (95% Cl) (16.95, NE) (14.95, NE)
E
[3 ( \
8 40 Crossover adjusted Crossover: 123/146 (84.2%)
bod ARPI change patients who discontinued
§ 2 with radiographic progression
a HR = 0.80 (95% Cl, 0.48-1.33) ["Lu-PSMA-617
o 7 - - -
0 6 12 18 24 30

Time From Randomization, mo

1 a ES 2023 LIA 2 Papi oc o MA nie st romana,

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Per Press Release?
Plans for FDA expanded filing based on pre-planned OS analy:
at appr n fraction del

in the ITT population, unadjusted for cro

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23. PSMAfore: Response Rates!

PSA Responses
177Lu-PSMA-617 (n = 213)

A,

Bost Change From
Baseline in
8

decrease
250%: 57.6%

ARPI Change (n = 221)

Bost Change From

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# 60
E
E
&
5 40
El
£ 30
2
¿2
10
0
ORR, %
(85% Cl)
mDOR, mo
(95% Cl) [n]

Best Overall Responses
I ARPI change (n = 74)

M '’Lu-PSMA-617 (n = 71)

Unknown
Type of Response

AL

'SMA-617

ARPI Change
50.7 14:
(38.6-62.8) (7.7-25.0)

13.63 10.05
(11.56, NE) [36] _ (4.63, NE) [11]

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24. PSMAfore: Safety!

Time to Symptomatic Skeletal Events
*Lu-PSMA-617 ARPI Change

(n = 234) (n = 234)
Events, n (%) 25 (10.7) 59 (25.2)
‘Symptomatic
at 21 (9.0) 54 (23.1)
Death 4(17) 5(21)
Median, mo
(85% CI) NE (NE, NE) NE (15.61, NE)
HR (95% Cl) 0.35 (0.22-0.57)

1Lu-PSMA-617 had a manageable safety profile

and was well tolerated in patients with no prior
taxane therapy

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TEAEs
a W"ILu-PSMA-617 | ARPI Change

o) (n= 227) (n= 232)
Any 223 (98.2) 223 (96.1)

Grade 3-4 77 (33.9) 100 (43.1)
Serious 46 (20.3) 65 (28.0)

Treatment-related 764) 5(22)
Fatal (grade 5) 4(1.8) 5 (22)

Treatment-related o 1(0:4)
Leading to dose
aa 8(35) 35 (15.1)
Leading to
res 13/57) 126.2)

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25. Phase 3 SPLASH: 17/Lu-PNT2002 PSMA (PSMA-I&T)
After 2L Hormonal Treatment!

Dosimetry and Safety Run-In Randomization Expansion (390 Patients)

LU-PNT2002
(a = 260)

Key Eligibility Safety and

+ mCRPC Preliminary Efficacy Primary
+ PsmAavid eT | CPR | : Acisacs 6.8 GBq QW x4 + (PFS
+ Dosimetry a Secondary
+ Changes in vital + ORR

signs, clinical labs, Prlortaxanes

ECGs Prior
bisphosphonates

PSA reduction

MOIM1 on prior ARAT Exploratory

Measurable disease + Pain PFS

+ PSMA PET

+ PSAPFS

+ 0s
+ PK

Abiraterone or
enzalutamide OSA

Screening
6 wk 32 wk 5 y, death, or loss to follow-up

{Amott on rt omit att 008 0 LS pay tS a CR PesiViewoom

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26. SPLASH: Positive Top-Line Results for
177Lu-PNT2002 After 2L Hormonal Treatment!

Press release Dec 2023 FDA Fast
Track

+ Met primary endpoint (rPFS per BICR) Designation

- 9.5 months for patients treated with '77Lu-PNT2002
compared with 6.0 months for patients treated with ARPI

- HR=0.71; P= .0088
+ Interim OS results were immature
+ 177Lu-PNT2002 demonstrated a favorable safety profile

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27. ECLIPSE: 177Lu-PSMA-18.T Versus Hormone Therapy in

Patients With mCRPC EJ
Accrual
Completed

Key Eligibility Criteria
+ Progressive mCRPC

previously treated with

androgen receptor-axis-

targeted (ARAT) therapy

> Long-term

castrate-resistant setting
(abiraterone,
enzalutamide,
apalutamide, or

darolutamide)

ap se ca gr PeerView.com

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28. Moving PSMA Radioligand Trials Earlier’

Accrual
PSMAddition (mHSPC): '77Lu-PSMA-617 with SOC vs SOC alone Completed
some roue) (RE (as

Safety folow-up
(up to 30 d) +
long-term safety
follow-up (12 mo)

Patient Population
+ Untreated or

mninaly tested Stratification
mHSPC + Disease volume +

+ Appropriate soc |_| age

(ADT and ARP!) + Previous or planned Bee Efficacy olow-up
+ PSMA-posiive on treatment of primary (Wend of treatment
['Ga]Ga-PSMA-11 tumor was any reason
PETICT ter than

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‘documented PD by

(N= 1.144)
BICR)

{tsi int goa NCTORTIONS, 2 Tags St ASCO A Ant TSH,

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29. Phase 3 PSMA-DC (PSMA-Delay Castration)’

177Lu-PSMA-617 vs Observation in PSMA Positive Oligometastatic Prostate Cancer

Key Eligibility Criteria

+ Adults with progressive castrate-sensitive
prostate cancer

+ 1-5 PSMA-positive M1 lesion on PSMA PET
and negative conventional imaging

+ All metastatic lesions amenable to SBRT

+ PSADT $10 months

+ Prior treatment of the prostate by RP or
XRT

+ Noncastrate T at baseline

+ Prior adjuvant ADT allowed if 212 months in
the past

ECOG PS 0-1

Long-term
follow-up

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30. Additional Studies:
Sequential or Combination Approaches?

+ RALU: feasibility of sequential a- and ß-eiter use in patients with bone-predominant mCRPC

First "7Lu-PSMA
dose

Prebaseline period

+ Primary endpoint: safety of "Lu-PSMA
Key secondary endpoints: OS and change from baseline in PSA and ALP levels

Patients, %

From mCRPC Diagnosis” During "LUPSMAS 7 POSt-"LuPSMA
{to Start of Le PSMA

“FIER STS PL PA 3 rt o sn mtd nm LU SU PeerView.com

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31. Where Do We Go From Here?

+ Different targets
+ Different isotopes
- "Lu-PSMA-617, 177Lu-PSMA-18.T, '77Lu-rhPSMA-10.1, 225Ac-PSMA, and more
+ Many combinations
- Immunotherapy
— DNA repair inhibitors
- Radiation sensitizers
+ Earlier disease stages

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32. Understanding the
Patients’ Journey

Oliver Sartor, MD

Professor of Medical Oncology
Mayo Clinic

Rochester, Minnesota

Go online to access full CME information, including faculty disclosures.

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33. 177Lu-PSMA-617 AE Profile

Dry mouth (typically
mild, reversible)

Gl Effects Myelosuppression
(check CBC before
each administration)

177Lu-PSMA-617

safety considerations

Radioactivity to others :
Fatigue, nausea,

pain flare
Back pain, bone pain

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34. Longer Follow-Up

+ 177Lu-PSMA-617 plus SOC delayed time to worsening in HRQOL and
time to skeletal events compared with SOC alone’

+ Longer exposure to 177Lu-PSMA-617 plus SoC was not associated
with a higher toxicity risk (5-6 cycles vs <4 cycles)?

Patients With 21 Event,

Event
4-4 Cycles (n = 240) Cycles (n= 289)

Any grade TEAE 234 (98) 285 (99)
Grade 23 TEAE 145 (60) 134 (46)
Serious TEAE 100 (42) 92 (32)

Any grade TRAE 205 (85) 246 (85)
Grade 23 TRAE 88 (37) 62 (22)
Serious TRAE 33 (14) 16(6)

Pan Lancet One 20292497102. Gt open Uy 20048838901

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35. Patient Characteristics, Treatment Patterns, and Outcomes Among
Early Adopters of 177Lu-PSMA-617: A Real-World US Study!

9/01/2021 613012023
+ The mean time from mCRPC diagnosis to initiation
Tepe of 177Lu-PSMA-617 was 339.3 days

date (index date)

Baseline period
rcs (including race/ethnicity)

+ Both clinical characteristics and observed PSA responses are consistent with results from the
VISION clinical trial demonstrating benefit with '77Lu-PSMA-617 in the real-world setting

+ In a subset analysis, more than half of patients on 177Lu-PSMA-617 experienced a 250% reduction in PSA
+ 29.6% of patients saw a 280% PSA reduction
+ 22.6% of patients saw a 290% reduction

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36. What Patients Want to Know

What patients say What patients say What patients say

“Who's going to be giving the
‘How does it work? drug?

How does this radioactivity find its ‘How long is it going to last?’ What side effects will | encounter?’
way to the cancer cell?” What kind of observation period
going to happen’

How providers can respond How providers can respond How providers can respond

+ Explain that PSMA is on the + Let patients know that the drug is i
een ‘administered over a very short un know that dry mouth is,

riod of time, <5 minutes

+ Show patients the PSMA-PET en 5 ë i ir

image so they can see where the + Explain that they are going to be Provide suggestions to cruels
es 5 the saliva flow, such as drinking
cancer is and that the isolated for a couple of hours Gee ae
radioisotope will target this + Describe urinary precautions non ler eh
location + Provide instructions for social
distancing for first few days

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37. Implementation of Multidisciplinary,
Team-Based Care in
PSMA-Directed Strategies

Oliver Sartor, MD

Professor of Medical Oncology
Mayo Clinic

Rochester, Minnesota

Go online to access full CME information, including faculty disclosures.

Copyright © 2000-2024, PeerView

38. Factors Contributing to Treatment Decisions for
Prostate Cancer Management!

Experience with

S treatment options
Extent of disease é

+ De novo vs recurrent 5 nz

0 Pertes + Interpretation of clinical

+ Molecular features Cancer- Clinician- trial data

Related Related Preferences and beliefs
Factors Factors

Life expectancy Patient- > Treatment- ilabili
Es = The ilabili
Comorbidities Related Related 5 ee nn

+ Concomitant medications Factors dnd
+ Performance status A et)
+ Presence of symptoms + Expected efficacy

+ Social supports

+ Preferences and beliefs Bra endi

ayant Cin On 22240 81824 PeerView.com

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39. Effective Implementation of Radioligand Therapy

Radioligand therapy is not offered in every clinic

+ Coordination between centers is needed for effective administration
+ Arrange for the patient to travel on an intermittent basis

Overcoming logistical coordination challenges-what's needed?

+ Radiation or nuclear medicine specialists
+ Compliance with radiation guidelines and safety
+ Protocol for nuclear waste disposal

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40. Multidisciplinary Collaboration: Team-Based Care‘?

Shared Decision-Making
+ Educating patients on treatment options aligned with their goals
+ Providing educational resources (eg, from patient advocacy groups)
Therapeutic Management
Assessing patient benefit from radioligand therapy
‘Supporting multidisciplinary care coordination — roles of urologist, medical oncologist, nuclear medicine physician,
radiation oncologist
Overcoming logistical challenges with radioligand therapy
Patient Safety
+ Monitoring and managing AEs
+ Educating patients on AE mitigation and management strategies
Addressing Patient Concerns
+ Educating patients on clinical trial opportunities
+ Addressing therapy-related concerns
+ Identifying barriers to treatment

ap DO ea BA ato 201924881592 Share NO ta Trt On 20217700728. PeerView.com

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41. Educating Your Patients and Staff About
the Importance of and Access to Clinical Trials

Why Is Clinical Trial Participation Important?
+ Clinical trials are a key step in translating research into
medicines that can cure illness, slow disease, and improve
quality of life for patients Providers need to discuss and offer
* Robust participation in clinical trials with diverse enrollment clinical trial opportunities to all patients
means a shorter timeline between medical discovery and
patient access to potentially life-changing treatments

Increasing diversity in clinical trial
enrollment is crucial

Clinical Trial Participation Offers Dual Benefits for Patients
1. Potential personal benefit: Patients may experience improved disease outcomes and better health if they receive
otherwise unavailable medical therapies
2. Social benefit: Clinical trial participation helps provide access for patients who may benefit from the new treatment
option by moving a new therapy closer to market

Increased Awareness = Greater Participation = Patient Access to New Therapies
Lack of Patient Awareness = Lack of Participation = Delays and Higher Costs
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