“Four-Ward” Progress in NDMM: New Developments With CD38 Antibody Quadruplets

Co-Chairs, Suzanne Lentzsch, MD, PhD, and Joshua Richter, MD, discuss multiple myeloma in this CME activity titled “‘Four-Ward’ Progress in NDMM: New Developments With CD38 Antibody Quadruplets.” For the full presentation and complete CME information, and to apply for credit, please visit us at https://bit.ly/3x3oWA3. CME credit will be available until May 23, 2025.

1. “Four-Ward” Progress in NDMM
New Developments With
CD38 Antibody Quadruplets

Suzanne Lentzsch, MD, PhD Joshua Richter, MD
Professor of Medicine Associate Professor of Medicine
Director of the Multiple Myeloma and Tisch Cancer Institute | Al
Amyloidosis Program at Icahn School of Medicine ||
Columbia University Medical Center at Mount Sinai
New York, New York Director of Myeloma ams
Blavatnik Family Chelsea Medical
Center at Mount Sinai
New York, New York

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

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2. CD38 Quads Are Now Included as Primary Therapy
in NCCN Guidelines for ASCT-Eligible NDMM'

Primary Therapy for ASCT Candidates

+ Bortezomib/lenalidomide/dex (category 1)
+» Carfilzomib/lenalidomide/dex

+ Daratumumab/lenalidomide/bortezomib/dex

Quad Options Useful in Certain Circumstances* Dara + VRd supported by trials such as GRIFFIN,
and now PERSEUS?

+ Daratumumab/VTd

+ Daratumumab/KRd

+ Daratumumab/cyclophosphamide/Vd
+ Isatuximab/RVd

ted regimens to show CD38 quadruplts; consul NCCN guidelines for complete list
NON Cte raso Cudeines m Onosogy Mathie Mylene, Vorson 42021. Mp vana o pasional tac lpdmyeoma pd en
2. Voorhees PM et a. Blood, 2020:136:996:945. 3. Sonneveld Petal N Engl J Med. 2026.390:301.313, PeerView.com

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3. CD38 Triplets and Quads Are Included
as Primary Therapy for ASCT-Ineligible NDMM'

Primary Therapy for Non-ASCT Candidates

Preferred Based on MAIA, which established

+ Bortezomib/lenalidomide/dex (category 1) a mia dara + AS ine
+ Daratumumab/lenalidomide/dex (category 1) Rey ACT

Other Recommended Options
+ Daratumumab/bortezomib/melphalan/prednisone Based on ALCYONE, which showed
sem) $ the efficacy of quadruplet therapy
with dara + VMP in ASCT-ineligible
+ Daratumumab/cyclophosphamide/bortezomib/dex NDMM?

+ Carfilzomib/lenalidomide/dex

1-NCCN Cinial Practice Guideines in Oncology. Mute Myeloma, Version 42024, htps/Imww.ncen orgproessionalsiphsiian_gs/pdmyeloma pa =
3 Kumar SK oa ASH 2022 Abort 4808 3 Macs MV al ASH 2022 Abst 4561 PeerView.com

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4. Despite Progress, Uneven Integration
of Antibody Platforms Into Myeloma Care Persists!

AstLine

Pl based
INSIGHT MM: treatment en
shift patterns from 1L to pc
2L in MM from 2016 to oT
2021 (N = 3,263) me. 191 (15%)
=—
Treatment shift patterns
from 1L to 2L therapy for
patients who received
frontline ASCT
1. Puig Net a. ASH 2022. Abstract 1859. PeerView.com

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5. Our Goals for Today

Improve your knowledge of the latest clinical trial and real-world
evidence supporting CD38-based quadruplets in NDMM

Equip you with the skills you need to recommend CD38-based
quads for patients with NDMM

Provide you with guidance on practical considerations when using
CD38-based platforms in NDMM, including dosing and safety

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6. New Directions With

CD38 Quads in NDMM

7. GRIFFIN: In This Phase 2 Trial, Adding Dara
to a Standard Triplet Deepened Response, Improved PFS'

D-RVd Group RVd Group
MSD.PD,o NE =PR =VGPR CR mStingent CR =SD,PD, or NE =PR =VGPR =CR Stringent CR
100 cree 100 Ror
Eater
90 beta 90 13%
70 70 =
eae Sener:
= 60 Ester * 60 2 =
is om Eso beter
= 40 = 40 oo
rer

£ o — * Y

20 185% 20

10 2 a a 10

o+ 3 +
Endofinduction EndofPost- Final Analysis End of Induction EndofPost- Final Analysis
‘Autologous HSCT Autologous HSCT
Consolidation Consolidation
y PFS,
87.2 70
HR = 0.45 (95% Cl, 0.2
1. Voorhees PM et al. Lancet Haomatol 2023:10:0825-0837. PeerView.com
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8. CASSIOPEIA: Adding Dara Improved PFS vs Observation
in Patients Treated With VTd Induction/Consolidation!

+ Aprespecified analysis showed
significant interaction between
maintenance and
induction/consolidation therapy

+ PFS benefit was observed for
VTd/daratumumab versus
VTd/observation

Patients Progression Free and Alive, %

+ PFS was not different for

D-VTd/daratumumab versus der

D-VTd/observation IM VTADARA.
m ovtaosv
m DVTADARA

+ Nominal P value.
4. Moreau Pt al, ASCO 2021. Abstract 8004.

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VTADARA

D:VTADARA

vrsoBv
HR (95% CI) pr

VTADARA vs VIGIOBV 7
D-VTA/DARA vs D:VTd/OBV/

176

216
217

155

131
174
195
198

0.32(0.23-0.46) <0001
102071147) 9133

4 15

1
1
15 8 2

na
7% 0 0

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9. PERSEUS: Phase 3 Comparison of Dara + VRd
vs VRd Induction in ASCT-Eligible MM!

Induction
4 cycles of 28 days

Consolidation Maintenance
28-day cycles

D-vRd DR

Dara: 1,800 mg Dara: 1,800
mg SC Q

Inclusion
Criteria

Transplant-

eligible

R: 10 mg
days
NDMM
‘Aged 18-70
years
ECOG PS <2
N=709

Discontinue dara therapy only ator
224 months of DR maintenance for
patients wih 2CR and 12 months of | | of CR without PO of

sustained MRO nogativy recurence of MRO

Transplant

+ Primary endpoint: PFS
+ Key secondary endpoint: overall 2CR rate, overall MRD-negativity rate, and OS

1. Sonneveld Peta. N Engl J Med. 2024:290:301-319, PeerView.com

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10. PERSEUS: Adding Dara to VRd Induction
Substantially Improved PFS vs VRd Alone

PFS at 48 months was 84.3%
in the D-VRd group and
67.7% in the VRd group*

+ HR for disease progression
or death = 0.42; P< .001

Patients Surviving Without
Disease Progression, %
Reese

HR for disease progression or death = 0.42 (95% Cl, 0.30-.59)
P<.00t

o

0 3 6 9 1215 18 21 24 27 30 33 36 39 42 45 48 51 54
Time Since Randomization, mo

No. at Risk
DVRS 355345 33 329 327 322 318316 313 309 305 902299 205 286 226 90 11 0
VRS 354335 321 311 90429291 283 278 270258 247 238 228219 175 67 13 0

+ Median folow-up: 47.5 mont en

‘Sova Petal Eng ed, 2024200301313. PeerView.com

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11. PERSEUS: Safety Summary!

Most Common Adverse Events (Safety Population)

Event, n (%)

Any adverse event 349 (99.4)

Hematologic adverse event

Neutropenia 243 (69.2)
Thrombocytopenia 170 (48.4)
Anemia 78 (22.2)
Febrile neutropenia 34 (9.7)

Second primary cancer 37 (10.5)

351)

Grade 3 or 4

321 (91.5)

218 (62.1)
102 (29.1)
21 (6)
33 (9.4)
NA

VRd (n

Any Grade

344 (99.1)

204 (58.8)

119 (34.3)
72 (20.7)
38 (11)

25 (7.2)

347)

Grade 3 or 4

297 (85.6)

177 (51)
60 (17.3)
22(6.3)
35 (10.1)
NA

Any infusion-related reaction 21 (6)

1. Sonneveld Peta. N Engl Y Med. 2024:390:301-313,

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30.9)

NIA

NIA

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12. PERSEUS: Safety Summary’ (Cont’d)

Most Common Adverse Events (Safety Population)

= D-VRd (n = 351) VR (n
Any Grade Grade 3 or4 Any Grade Grade 3 or4
Nonhematologic adverse event
Diarrhea 214 (61) 37 (10.5) 188 (64.2) 27 (78)
Peripheral sensory neuropathy 188 (53.6) 15 (4.3) 179 (51.6) 14(4)
Constipation 119 (33.9) 8(23) 118 (34) san
Pyrexia 111 (81.6) 8(23) 109 (31.4) 926)
Insomnia 95 (27.1) EICH) 61 (17.6) san
Asthenia 94 (26.8) 1284) 89 (256) 926)
Cough 85 (24.2) 103) 51 (14.7) 0
Fatigue 84 (23.9) 10(28) 92(26.5) 18 (52)
Rash 82(234) 9(26) 94 (27.1) 17 (4)
Back pain 80 (22.8) 2(06) 66 (19) 103
Peripheral edema 72205) 4(14) 74 (21.3) 103
Nausea 71 (20.2) 2(06) 58 (16.7) 2(08)
Infection 305 (86.9) 124 (853) 266 (76.7) 95 (27.4)
covi-19 123 (35) 12(34) 83 (23.9) 4(12)
Upper respiratory tract infection 11161) 2(06) 87 (25.1) san
Pneumonia 64 (18.2) 37 (10.5) 38 (11) 2161)
1. Sonneveld eta. N Engl J Med. 2024:290:201-319, PeerView.com

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13. Ongoing Phase 3 CEPHEUS Trial Will Provide More
Information on Dara Quads as Primary Therapy!

Induction/Consoli

Maintenance
28-day cycles

e SC dara/Rd cycles 9+
E Di mg SC Q4W

Inclusion Criteria : 1.3 mg/m? SC days 1, 4, 8, 11 ae el

NDMM without En d: 40 mg PO days 1, 8, 15, 22

intent for transplant 9

as initial therapy

Long-term
ECOG PS 0-2

safety,

‘subsequent
therapy, PFS2,
CrCi 230 and survival
mUmin/1.73 m2 2 z follow-up
es n Rd cycles 9+

Primary endpoint: overall MRD negativity

Secondary endpoints: PFS; durable MRD; ORR, VGPR, and CR; PFS2; and OS

1. Zwoogman $ et al. J Gin Oncol. 37:(suppl 15. Abstract TPS8086

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14. The SKylaRk Trial: Efficacy of Isa/KRd
in All-Risk Transplant-Eligible NDMM!

Once-weekly 100 88
administration of
Isa/KRd demonstrated a PFS, % OS, %
high ORR and favorable 1
MRD negativity, pis ss
indicating its MRD Negativity 105
effectiveness in treating 80

all-risk transplant-
eligible NDMM (N = 50;
45 evaluable)

2
3

Patients, %
2
3

20
o En
Cycle 8 AutoSCT
1. O'Donnell EK et al. ASH 2023. Abstract 4671, PeerView.com
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15. GMMG-HD7: Adding Isatuximab to RVd
Enhances Response and MRD Negativity in NDMM

GMMG-HD7: MRD Negativity (Primary Endpoint) and Response Rates at End of Induction’

Patients With MRD Negativity
at End of Induction

60 OR: 1.83 (95% Cl, 1.34-2.51)
1

Response Rates at End of Induction

misa/RVd mRVd P=.02

P<.00
P<.001
50.1 80 A
40 4
60
P= 15 Ñ
20 id P=46 141.715
E LEE
o
CR

Isa/RVd (n = 331) RVd (n= 329)

Patients, %
8
Patients, %

2nCR 2VGPR 2PR

Not assessable/missing MRD status Significant increase in 2VGPR with Isa/RVd;
low: Isa/RVd: 10.6%; RVd: 15.2% significant increase in ORR

1. Goldschmidt H et al. Lancet Haematol 2022;9:08 10-0621, PeerView.com

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16. Daratumumab Quadruplets Continue
to Show Efficacy in Nontransplant Settings

PFS From ALCYONE!

+ After a median follow-up of dl
78.8 mo, D-VMP continues to
improve versus VMP

1 medion, 37.3 mo

‘Surviving Without Progression, %

122% vp: median
HR = 0.43; 95% Cl, 0:36:02; P< 0001 le 197 mo

o
oe RH MO Te OM
‘Treatment Duration, mo

1. Mateos M-V etal. ASH 2022. Abstract 4561 PeerView.com

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17. Isa/VRd: A New CD38 Quad Option in NDMM?

Randomized Phase 3 IMROZ Trial Comparing Isa/VRd With VRd
in ASCT-Ineligible NDMM! (N = 484)

Primary endpoint: PFS Primary endpoint was met, showing that
Secondary endpoints: safety the addition of Isa to VRd significantly
rate of 2VGPR, MRD negativity improves PFS in ASCT-ineligible

rate, and CR rate patients with NDMM2

Sarclisa® (isatuximab-irfc) Phase 3 trial met primary endpoint of
progression free survival in patients with newly diagnosed multiple
myeloma not eligible for transplant

Results at ASCO 20243

JR aan O 2 en) np na ren
pa I-progression-Iree-survival-in-patients-with-newiy-diagnosed-multiple-myeloma-not-elgible-for-transplanv. 3. Facon T et al. ASCO 2024.

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18. Case Instruction: Who Is a Candidate for a CD38 Quad?

a 64-year-old woman with PMHx of HTN, HLD, and type 2 DM with NDMM

BMBx showed atypical plasma cells
comprising 60%-70% of marrow cellularity

FISH: monosomy 13, and 1q gain

lambda FLC: 4. 2
kappa FLC: 0.77 mg/dL

SFLC ratio: 5.78

Further workup:
5.4 mg/L, 162 units/L,

24-hour urine protein: 175 mg
and 4.1 g/dL

Serum/urine immunofixation showing
IgG-Lambda monoclonal protein

R-ISS stage Il: initiated >
on dara + VRd

FREE LAMBOA LIGHT CHAINS. SERUM
et Range _ [test Ret Range 057-265 my

Plan is to collect stem Torre 158 Er
TE] ra

cells after 4 cy AZ ane
TO 0810 03.

followed

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19. Case Instruction: Who Is a Candidate for a CD38 Quad?

Sent for a f/u CT che:

, which revealed a

shadow on her vertebrae

MRI revealed T8 compre

Hemoglobin: 6

ion fracture; workup
revealed IgG-Kappa myeloma

tinine: 1.1,

calcium: 9.7, albumin: 2.7, B2M: 13

Candidate for CD38

quad but unlikely
candidate for ASCT

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sao

ail uo aba arr
re

on

oss
on
se

BMBx showed

iu

ay

ny

80% infiltration with plasma cells
FISH: hyperdiploidy

sn

5,8

se

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20. Real-World Evidence
With CD38 Antibody

Quadruplets

21. Are Quadruplets Ready for the Real World?

+ Real-world comparison of D-VRd =

x A Ven 191655 549 646)
induction (N = 326, 2018-2022) Women 15) 4541454)
compared with 1,000 consecutive ¿+0 as] Zn
patients treated with VRd from cee 134409) 50 668)
2007 to 2016 Area rte Nove 169 8
on 309) 8
. ; a Era

Approximately 99% of both EA ee sar)

cohorts underwent ss En

transplantation 3 Fr) fre esse)
ee nues 163009
2 irre) Era
3 2660 EE
Pon 250 (8.2) EN
aang ‘Sion. foot

1. Joseph NS et a. ASH 2023. Abstract 647. PeerView.com

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22. Real-World Evidence Mirrors Results From PERSEUS

« D-VRd induction appeared to yield a PFS benefit in both
standard-risk and high-risk patients’

* At 2 years, PFS was 93% with VRd and 98% with D-VRd

» At 4 years, the PFS was 61% versus 85% (P < .001),
favoring quadruplet therapy

+ Results mirror evidence from PERSEUS

1. Joseph NS et al. ASH 2023. Abstract 647. PeerView.com

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23. In the Real World, What Principles
Can Help Ensure CD38 Antibody Safety?

Q Oral HSV prophylaxis (regardless of zoster vaccination status)

Q Appropriate premedication (acetaminophen, diphenhydramine, dexamethasone, and/or
methylprednisolone, and montelukast)

Q Pretherapy blood screening: Type and crossmatch, screen for hepatitis B core Ab and surface
Ag prior to treatment initiation and every 6 months; initiate prophylaxis with entecavir if hep B core
Ab positive

Q SC versus IV administration; observation period required after first dose
> 3 hours for SC and 6 hours for IV; average infusion time is >4 hours

Q Treat infections aggressively
> Consider immunoglobulin replacement for IgG levels <400 mg/dL and if there is a history of
infection with hypogammaglobulinemia

y Daal (aatumumab) Posing tomaten. Mis wan seta a going don ONE OH EL
2 Sarcisa(satuximab-e)Proserbing Information. aps ha accessdaa da gowdrugsallda-SocsNab/2020/7611 1380008 a u
3. Leo SK et al. Cin infect Dis. 2021:73:01372-01375. PeerView.com

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24. Case Instruction: Reflecting Real-World Practice

Reconsider our 64-year-old woman with PMHx of HTN, HLD, and type 2 DM with NDMM

mme 77777) a)
Range

Latest Unas g/t.

[FREE LAMBDA LIGHT CHAINS, SERUM) BMPCS on BMB)
Ban

en Re Range 057-253 mg/d

EIA

FISH: t(4;14),
monosomy 13, and
1q gain

Further workup: beta-2
microglobulin:

.4 mg/L,
LDH: 162 units/L,
and albumin: 4.1 g/dL

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Baseline 70

c#2 #1

R-ISS stage Il and Recommendation is to
candidate for a CD38 use a CD38 quad,
quad and ASCT; dose-reduce

however lenalidomide (renal

If neuropathy and insufficiency), and
elevated creatinine replace bortezomib with
were present carfilzomib (neuropathy)

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25. Achieving MRD
Negativity in NDMM

What Is the Role
of CD38 Quads?

26. In PERSEUS, Adding Dara to VRd Improved
ORR and Induced Deeper MRD-Negative Responses!

Summary of Tumor Response and MRD Status (ITT Population)

Variable, n (%) D-RVd (n = 355) VRd (n = 354)
‘Tumor response
Overall response [95% Cl] 343 (96.6 [94.2-98.2)) 332 (93.8 [90.7-96.1]) E
CR or better 312 (87.9) 248 (70.1) <001
VGPR or better 338 (95.2) 316 (89.3) =
so 4(14) 9(25) =
PD 2(06) 103) -
NE sam 1204) =
= MRD status
MRD-negative status
10* sensitivity threshold 267 (752) 168 (47.5) <001
10% sensitivity threshold 231 (65.1) 114 (82.2) -

Sustained MRD-negative status, assessed

at 10 sensitivity threshold, for 212 mo 280 (64.8) 105 (29.7) =

1. Sonneveld Pet al. N Engl J Med. 2024;380:301-913, PeerView.com

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27. DRAMMATIC: Lenalidomide + Daratumumab
as Post-ASCT Maintenance Therapy":

MRD assessment will help guide therapy

Randomization

Lenalidomide

Stop assigned
‘maintenance

Registration Randomization

maintenance therapy

+ Patents may rita any me folowing induction nara ñ
Y Kriéman A tal ASH 2020 Aste! 1518 2. pa man nical ovlet2/showNCTOAD7 457. PeerView.com

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28. IsKia: Isa/KRd as an Upfront Quadruplet Option in NDMM'

Induction Post-ASCT Consolidation Light Consolidation
4 cycles of 28 days 12 cycles of 28 day
ax Isa Rd

Inclusion Criteria A
* patents ages ho Mobitzation om
<70 years on. sexe = Cy: 230m
Stratification followed by
mg PI 2 G-CSF for stem-cell
+ Centralized FISH: st
standard Gus
risk/missing vs.
high risk defined MEL-200 ASCT
as del(17p) ee
andlor t(4;14) mont,
andlor 1(14:16) followed by
ASCT

ISS (vs ll and
Mm)

î î

MRD by NGS ‘MRD by NGS MRD by NGS MRD by NGS

+ Primary endpoint: MRD negativity rate (10)

1. Gay F et al ASH 2023. Abstract, PeerView.com

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29. IsKia: Isa/KRd Induced Higher Rates of MRD-Negative
Responses Compared With KRd Alone

Primary endpoint: post-consolidation MRD negativity (ITT)!

NGS, 105 NGS, 10%
10 OR: 1.67; P= .049 19 OR: 2.29; P<.001
90
80 ar

Patients, %
Patients, %

0
Isa-KRd (n= 151) KRd (n = 151) Isa-KRd (n= 151) KRd (n = 151)

1. Gay F et al ASH 2023. Abstract, PeerView.com

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30. IsKia: Use of Isa/KRd Led to Higher
MRD-Negative Rates Across Patients Subgroups’

10° Cut-Off

‘Overall ne

Favors KRd Favors IsalKRd

1. Gay F otal. ASH 2023. Abstract 4.

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or
167 (1.00:280)

170 0923.12)
230 (0687.70)

180 078341),
186(076487)
276 (0.521456)

148 (0583.75)
179 (094-343)

1.14 (0:83.60)
30801

0.6638

080

0701

10° Cut-Off
OR (95% cl) Imeraction P
Overall 220 (143367) a
Cytogenetic risk
as por IMG _
‘Standard isk 210122381)
High sk 4.95 (148-1661)
Not HRCA
HRCA 221 (1.1442)
HRCA 20 088470) 29
2+ HRCA 9.05 (1.57-52.14)
208080469) 7766
235 (130426)
1 176 (864.89)
" amas) 4968
av, 192 (0924.02)
020 10 5214

== —
Favors KRd Favors Isa/KRd

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31. Isa/KRd Was Tolerable, With a Consistent
and Predicable Safety Profile’

a KRd (n
en) Grade 3 or4 Any Grad
Patients with 21 hematologic toxicity 83 (55) 61 (40) 67 (44)
‘Anemia 32(21) 5(3) 28 (19) 5(3)
Neutropenia 62 (41) 55 (36) 39 (26) 33 (22)
Thrombocytopenia 51 (34) 2215) 38 (25) 25(17)
Patients with 21 nonhematologic toxicity 136 (90) 61 (41) 129 (85) 56 (37)
Infections (excluding COVID-19) 55 (36) 23 (15) 49 (32) 17 (11)
Asthenia/fatigue 37 (25) 5(3) 40 (26) 3 (2)
Dyspnea 20013) 2(1) 906) 4 (<1)
Rash 33 (22) 5(3) 40 (26) 5(3)
Peripheral neuropathy 22 (15) o 25(17) o
Infusion-related reactions 30 (20) 5(3) 2(1) o
Cardiac disorders 1107) 1(<1) 19 (13) 56)
Vascular disorders 29 (19) 76) 33 (22) 15 (10)
Hypertension 5(3) 2(1) 6(4) 3)
Thromboembolism 128) 403) 16(11) 96)
Gastrointestinal disorders 79 (52) 10 (7) 73 (48) 8(5)
Nausea 36 (24) 46) 3121) 2(1)
18 (12) 2(1) 12(8) 161)
4127 st 37 (25) 56)
1.Gay Fetal. ASH 2023. Abstract, PeerView.com

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32. Conclusions and Take-Homes

+ Given the unclear role of ASCT in the era of + Quads are well tolerated in non-ASCT-eligible
quadruplets, the new term “FIT” is preferred over patients
“ASCT-eligible” and will extend the pool of patients - ALCYONE trial; upcoming IMROZ

for a more intensive induction treatment Potential 3 chics nef
— Potential for use as dose-reduced options
- Quadruplets including CD38 mAb, IMiDs, pl

proteasome inhibitors, and steroids are + Unmet needs
‘superior to triplets and are the new SOC for — Frail patients and ultra high-risk disease (22
fit patients HRCG markers)

— CASSIOPEIA, GRIFFIN, PERSEUS,
GMMG-HD7, IsKia trials

— Role of ASCT is unclear but was used in
most of the current trials such as GRIFFIN,
PERSEUS, and GMMG-HD7

— CEPHEUS for fit patients does not include
ASCT

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