Assessing Current and Potential Approaches in Multiple Myeloma: Updates From Madrid 2024

Philippe Moreau, MD, discusses multiple myeloma in this CE activity titled "Assessing Current and Potential Approaches in Multiple Myeloma: Updates From Madrid 2024." For the full presentation, please visit us at www.peervoice.com/XRB870.

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Assessing Current and Potential Approaches in Multiple Myeloma:
Updates From Madrid 2024

Learning Objectives
Evaluate clinical trial data assessing current and investigational treatment
approaches in transplant-eligible and transplant-ineligible newly diagnosed
multiple myeloma
Recognise the clinical relevance of data evaluating different treatment
sequencing approaches in the management of relapsed/refractory multiple
myeloma

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Part 1 of 2: Selecting Therapeutic Strategies in Transplant-Eligible
and Transplant-Ineligible NDMM

Philippe Moreau, MD
Professor of Hematology
University Hospital Nantes
Nantes, France

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isclosures

Philippe Moreau, MD, has a financial interest/relationship or affiliation in
the form of:

Advisory Board for AbbVie Inc.; Bristol Myers Squibb Company; Celgene
Corporation; Janssen Inc.; Pfizer Inc.; and Sanofi.

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Frontline Therapy Options in NDMM

Yes Eligibility for ASCT No
A First option:

DaraRd [l, A]
DaraVMP [I, A]
VRd [lA]

If first option is not available
VMP [L A]

\ ) Rd [I, A]

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CASSIOPEIA St +DvsVTd+D

Part 2:
Part 1: Induction/consolidation phase Maintenance phase, , Follow-up phase

Induction idati Maintenance
DARA

Follow-up

Fr
=

=
a
2
=
E

(=

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CASSIOPEIA Stu

D-VTd =D vs VTd + D (Cont'd)

72-month PFS
'
i

Dara:
median, NR

HR, 0.49; 95% Cl, 0.40-0.59;
P< 0001

O 6 1 18 243036 42 48 546066 72 78 8490

Time Since Randomisation, Months

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PFS, %

100

#0 D-VTd/Dara:

median, NR
60

VTd/Dara:

median, NR
2 D-VTa/OBS:

median, 72.1 mo
20

VTd/OBS:
median, 32.7 mo

O 6 12 18 243036 42 48 54 60 66 72 78 8490
Time Since Randomisation, Months

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CASSIOPEIA Study: D-VTd + D vs VTd + D (Cont'd)

ity Rate, %

MRD-Negati

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Sustained MRD 224 Months
100%
90%
10“: P=.0028
= 10°*: P = 0023
rn 10: P< 0001
50% 408%
50% -
40%
30%
20%
10%
0%
D-VTd/ D-VTd/ VTd/ VTd/
Dara OBS Dara OBS

(n=229) (n=229) (n=213) (n = 215)

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PERSEUS TRIAL: D-VRd + D-R vs VRd +R

Median follow-up:
47.5 months

Median time to reach
post-consolidation:
9.7 months

48-month PFS
»o

80
60

40

PFS, %

20

HR, 0.42; 95% Cl, 0.30-0.59;
IP <.0001

0 3 6 9 25 = 21 24 27 30 33 36 39 42 45 48 51 54

o

Months

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PFS according to MRD status (10-6)

D-VRd: MRD neg

'VRd: MRD neg
MRD pos
VRd: MRD pos

0 3 6 9 1 % 1 21 24 27 30 33 36 39 42 45 48 51 54

Months

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GMMG-HD7 TRIAL: Isa-RVd vs RVd

GMMG-HD7 Interim Analysis: MRD Negativity by
NGF (10-5) After Intensification (ITT; by response)

Patients with MRD negativity and indicated response status GMMG-HD7 Interim oh MRD
Negativity by NGF (10-5) After
P<.001 misa-RVd mRVd Intensification (Per Protocol)
—
© 36.4% Patients with MRD negativity after
0 having completed intensification
à 50 43.8%
Lu OR, 198 (95% CI, 139-285)
5» P<.001
re 25% misa-RVd
o 565% MRVd
2VGPR 2CR

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CARTITUDE-2: Cilta-cel + Lenalidomide Maintenance in

Suboptimal Response to Frontline ASCT

Overall Response Rate MRD negativity (10-5), n/N (%)

rn 94.1(16/17) Overall 12/17 (70.6)
MRD-evaluable patients 12/15 (80.0)
80
Es PFS and OS
€ 100 100
Lao £
E feo u.
20 sg g
Sa co Zo
o av 2
8 5 18-mo PFS rate (95% Cl): 5 40 18-mo OS rate (95% Cl):
52 93.8% (63.2-99.1) 3 93.8% (632-9911)
67 42 1PFS event out of a 20 108 event out of
a 17 patients 17 patients
o o
ERRE RETTET
Months Months

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IMROZ: Isa-VRd vs VRd

162 PFS events: 84 (31.7%) in Isa-VRd; 78 (43.1%) in VRd 128 OS events: 69 (26.0%) in Isa-VRd; 59 (32.6%) in VRd

— Isa-VRd — VRd + Censor

2

aa 60-moPFSrate:632% à

08 MPFS: NR £

07 3

06 q

05 5

83 6 60-mo PFS rate: 45.2%

02 mPFS: 54.34 mo

O1 {Log-rank P = 0005 (95% Ci, 45207 to NR)

0 HR, 0.776; 99.97% Cl, 0.407-148

O 6 12 18 24 30 36 42 48 54 60 66 72

E
go

© 6 12 18 24 30 36 42 48 54 60 66 72

Time, Months Time, Months
% Patients Isa-VRd(n=265) VRd (n= 181)
CR 747 641
MRD- CR (105 by NGS) 55.5 409

Sustained MRD- for at

least 12 months us us

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BENEFIT/IFM2020-05: Isa-VRd vs Isa-Rd

MI8 Primary Objective
(MRD at 10°)

N= 270 A =
_ Treatment Phase Until Cycle 18 Ar nn]
Randomisation 1:1 Cycles 1> 18 4-week cycles/18 months Week cycles ‘SPM
Stratified by:
+ Age: <75 and Induction Cy1-12: \ (Induction Cy13-18: Y | (Induction Cy19-PD:) / Primary endpoint:
275 years N IsaVRd IsaVR IsaR os
. i D De 01 072078 5 (oy secondary
Cytogenetic A | | APA || PA 1-1 ‘endpoints:
result by FISH [omo ME 270) 25 me im (70) 25 me. CR rate, MRD- CR
(Modified AAA Nbre) (NGS, 10") rate,
Perrot score) Induction Cyl-12: \) (Induction Cyi3-18:)) (Induction Cy19=PD:) | *VPR rate, PFS. 0S,
+ Centre ’ IsaRd Isar Isar
k Bee ee or 08 vw 02200 | Discontinue based on
0010 eh, Eo] ee PD, unacceptable
00250 ia La PO) 25 me [atop 250m toxicities, patient
Min te Ft + | withdrawal
* 2 ÉS > rs =
MRD (bone In case of 12 months 18 months 24 months Yearly
marrow aspirate) PR or better

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BENEFIT/IFM2020-05: Isa-VRd vs Isa-Rd (Cont'd)

Primary Endpoint: MRD- Rate at 18 Months — ITT Population

OR (95% Cl):
OR (95% Cl):
3.88 (2.27-6.62) ares De)
P<.0001 <
—— —— OR (95% Cl):
° exc 274 (154-487)
2.97 (16-55) pesao
50 P=.0005 53
R40 oo ——
El
5 30
% 20 M Isa-VRd
Ñ B Isa-Rd
10
o
107 107 103 107
12 mo 18 mo

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Abbreviations and References

Frontline Therapy Options in NDMM

Abbreviation(s): ASCT: autologous stem cell transplantation; DaraRd: daratumumab/lenalidomide/dexamethasone;
DaraVMP: daratumumab/bortezomib/melphalan/prednisone;

DaraVTD: daratumumab/bortezomib/thalidomide/dexamethasone; MM: multiple myeloma; NDMM: newly diagnosed
MM; Rd: lenalidomide/dexamethasone; VCD: bortezomib/cyclophosphamide/dexamethasone;

VMP: bortezomib/melphalan/prednisone; VRd: bortezomib/lenalidomide/dexamethasone;

VTD: bortezomib/thalidomide/dexamethasone.

Reference(s): San Miguel J. 29th European Hematology Association Congress (EHA 2024). Session ID HUIH9002.

CASSIOPEIA Study: D-VTd + D vs VTd+D

Abbreviation(s): D/DARA: daratumumab; D-VTd: daratumumab/bortezomib/thalidomide/dexamethasone;
OBS: observation; VTd: bortezomib/thalidomide/dexamethasone.

Reference(s): Moreau P et al. EHA 2024; Abstract $204.

CASSIOPEIA Study: D-VTd + D vs VTd + D (Cont'd)

Abbreviation(s): NR: not reached; PFS: progression-free survival.
Reference(s): Moreau P et al. EHA 2024; Abstract $204.

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Abbreviations and References (Cont'd)

CASSIOPEIA Study: D-VTd + D vs VTd + D (Cont'd)

Abbreviation(s): MRO: minimal residual disease.
Reference(s): Moreau P et al. EHA 2024; Abstract $204.

PERSEUS TRIAL: D-VRd + D-R vs VRd +R

Abbreviation(s): D-VRd: daratumumab/bortezomib/lenalidomide/dexamethasone (VRd).
Reference(s): Sonneveld P et al. EHA 2024; Abstract $201.
Sonneveld P et al. N Engl J Med. 2024;390:301-313.

GMMG-HD7 TRIAL: Isa-RVd vs RVd

Abbreviation(s): CR: complete response; Isa: isatuximab; ITT: intention-to-treat; NGF: next-generation flow; OR: odds
ratio; RVd: lenalidomide/bortezomib/dexamethasone; VGPR: very good partial response.
Reference(s): Raab MS et al. EHA 2024; Abstract $202.

CARTITUDE-2: Cilta-cel + Lenalidomide Maintenance in Suboptimal Response to Frontline ASCT

Abbreviation(s): OS: overall survival; sCR: sCR: stringent CR.
Reference(s): Roeloffzen W et al. EHA 2024; Abstract $205.

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Abbreviations and References (Cont'd)

IMROZ: Isa-VRd vs VRd

Reference(s): Facon T et al. EHA 2024; Abstract S100.
Facon T et al. N Engl J Med. 2024; June 3. doil0.1056/NEJMoa2400712. Online ahead of print.

BENEFIT/IFM2020-05: Isa-VRd vs Isa-Rd

Abbreviation(s): AE: adverse event; FISH: fluorescence in situ hybridisation; NGS: next-generation sequencing;
PD: progressive disease; SPM: second primary malignancy.

Reference(s): Leleu X et al. EHA 2024; Abstract $203.

Leleu X et al. Nat Med. 2024; 3 June. Published online. https://doi.org/101038/s41591-024-03050-2.

BENEFIT/IFM2020-05: Isa-VRd vs Isa-Rd (Cont'd)

Reference(s): Leleu X et al. EHA 2024; Abstract $203.
Leleu X et al. Nat Med. 2024; 3 June. Published online. https://doi.org/10.1038/541591-024-03050-2.

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Part 2 of 2: Selection and Sequencing of Treatment in RRMM

Philippe Moreau, MD
Professor of Hematology
University Hospital Nantes
Nantes, France

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18. PeerVoice

isclosures

Philippe Moreau, MD, has a financial interest/relationship or affiliation in
the form of:

Advisory Board for AbbVie Inc.; Bristol Myers Squibb Company; Celgene
Corporation; Janssen Inc.; Pfizer Inc.; and Sanofi.

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Newer Therapeutic Options in “Triple-Class Exposed” RRMM

BCMA-directed
CAR T-cell

BCMA-directed
CAR T-cell

Ciltacabtagene
autoleucel

Idecabtagene
vicleucel

BCMA

BCMA

22 prior

22 prior

therapies

24 prior 23 prior =
BsAb Talquetamab cos GPresD | ice | therapies | MonumenTAL-1
A 24 prior 23 prior E =
BsAb Teclistamab CD3&BCMA | therapies | therapies» | Males TEC-1
24 prior 23 prior E
BsAb Elranatamab CD8&BCMA | norapiess | therapies | MagnetisMM-3

21 prior

22 prior

| MMY2001/2003/3002

therapies*

CARTITUDE-1/-2/-4

KarMMa
KarMMa-3

ARS —

® Including an immunomodulatory agent, a proteasome inhi

BCMA-directed

® Including an immunomodulatory agent and a proteasome inhibitor

r and an anti-CD38 antibody

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DREAMM-7: BVd vs DVd in RRMM

oa
(031-039)

im
18 months a

Pvolue

os 69%

PFS Probability

Time Since Randomisation, Months

Patients, %

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90

24.7% vs 9.6%

Cl, 19.4-3 (95% Cl, 6.2-13.9)
2VGPR MRD negativity
38.7% vs 17.1%

(95% CI, 32.5-45.1) (95% CI,12.7-224)

ORR 82.7%
(95% CI, 77.4-87.3) ORR 71.3%
(95% CI, 653-766)

2CR:346% roca 20R:17.1%

(95% Cl, (95% CL,

286-409) 127-224)
2VGPR:
46.2%

(95% Cl, (95% Cl,

595-718) 399-526)

BVd (n = 243) DVd (n = 251)

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DREAMM-8: BPd vs PVd in RRMM

PFS BPd(n=155)) PVd (n = 147)
M 5 jn Events, n (%) 62 (40) 80 (54)
months =
Median PFS
(65% C1) months | NR(20.6-NR) | 12.7 (91-185)

08 HR (95% Cl); P value | 0:52(0.37-0.73); < .001
tri
06

04

Proportion Alive and
Progression Free

02

m AL LL
0123456789101 1213 14 1516 17 18 19 20 21 2223242526 27 282930 31 3233343536 373839

Time Since Randomisation, Months

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CARTITUDE-4: Cilta-Cel vs SOC in Functional High-Risk MM

One Prior LOT and Functionally High-Risk MM One Prior LOT and Functionally High-Risk MM

HR, 0.27; 95% CI, 0.12-0.6 0006 100

100 Macon PES: NR (95% CL 18.00-NE) ee

12-mo DOR: 79.5% (95% Cl, $9.0-90.5)

5
§ 12-mo PFS: 77.0% (95% Cl, 603-873) I
a 75 8 75
A ig
Z 50 S< 50
2 av
Er ¿5
ga 25 Lo 25
se 2
Zé o =
© 9 2 15 o
0 3 6 9 2 15 18 21 24
PFS, Months Duration of Response, Months

(95% CI, 4.8-55.1); P <.0001
==
65.0 m Cilta-cel
m SOC
MRD Negative
5
(10-5 threshold) 08

n=40 n=39

Patients With One Prior LOT and Functionally High-Risk MM

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MagnetisMM-3: Elrana

tamab

Duration of Response

Overall Response

100 24-mo rate for pts with 100
90 2CR (95% Cl): 0 1“, Median OS, 24.6 mo (95% Cl, 13.4-NE)
& 80 87.9% (731-948) x 80
> 70 = 70
2 60 Ea]
E 24-mo rate for pts with É 60
3 OR (95% Cl): 3 50
2 30 | Median OR, mo (osx ci) 969% (544-767) 22
& 20 À— Pts with OR NR (NE-NE) 2 20
10 | — Pts with ¿CR NR (NE-NE) e o
o PFS >
92.30 9 BBB 2124.27 299980" 90 0 3 6 9 1215 18 21242730333639
Months 90 e EN Months
& so
25 24-mo rate for pts with
Eso 2CR (95% CI):
so 90.6% (76.9-96.4)
2 mu
2 30 | Median prs,mo (05% Cl)
À 20 | —Overal172(08-NE)
10 | —Pts with 2CR NR (NE-NE)
o

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O 3 6 9 12,15 18 212427303336
Months

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MajesTEC-1: Teclistamab

Best response:

80 ore: m sCR
(104/165) mck
60 m VGPR
x mr
2
a 2VGPR:
3 59.4
&
20

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PFS

wo —— Overall ——2CR —#-2VGPR
§
se *
es
Bs ©
av
25.
38
ga

Median, mo (95% CI) 30-1

2 D 1) 30-mo PES rate (95% Ci)

Overall 114(8.8-16.4)
2CR NR(269-NE)
2VGPR__ 26.7 (19.4-NE)

30.1% (22.9-37.7)
610% (48.9-711)
48.8% (38.5-58.4)

0 3 6 9 RO = 2124 27 30 33 36 39 42

PFS, Months

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-1& 2: Talquetamab
ORR ORR
100 88.6%
100 PR MVGPR MCR msCR (3135)
741
69.5
e 80. (06/143), (107/154) (52/78) ke scr: mscr
£ 60 g 60 51.4% CR
5 BVGPR: | 2 VGPR: E 12 VGPR: 5 sx
3° 59.4 591 Si à mVGPR
> = <a = | = | Pr
o
0.4 mg/kg 0.8 mg/kg Prior TCR o
sc QW SC Q2W Tal + Pom
Efficacy 0.4 mg/kgSC OBmg/kgSC Prior TCR
Outcom aw( 54) ( Efficacy Outcome
mFU, mo 29.8 23.4 20.5 mFU (range), mo 16.8 (1.2-25.1)
mPFS 75 12 77
(95% Cl), mo | (57-94) (64-145) | (arias) | | MPFS (95% Ch, mo NR (12.9-NE)

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Development/Experimental Therapies

Therapy & Rationale Outcomes AE

All-Oral Triplet Iberdomide Ixazomib | ORR 65% (36% VGPR/CR) Well tolerated

and Dexamethasone 12-mo PFS 52% low rate of non-haematologic grade
Phase 2 STUDY 12D 12-DOR 76% 3-4

Age 270 12-mo OS 86%

RRMM; 1 prior line

Cevostamab, a FCRH5xCD3' CORR; partial response [PR] or better as best | Grade 3-4: 62%

bispecific antibody response: of 67% neutropenia anemia,

Phase 1/2 CAMMA 2 STUDY thrombocytopenia, infections
triple-class refractory MM; a prior Serious AEs: 48%

BCMA-targeted ADC or CRS occurred in 71%

CAR T-cell therapy

Anitocabtagene autoleucel (anito- | ORR, 100% ‘CRS: 95% pts

cel) anti-BCMA 2CR rate, 76% ICANS occurred in 7/38 pts (5, Grs2;
CAR T-cell therapy 2VGPR rate, 92% 2, Gr3), with 1 Gr3 case in each DL.
Phase 1STUDY

(Pts with RRMM) 89% were MRD-neg at 10°° All cases of CRS & ICANS resolved
RRMM prior 23 prior lines of therapy with management and without

Kaplan-Meier estimated PFS rates for 6,12, | sequalae.
18 & 24 months were 92%, 76%, 64%, and
56%, respectively. No delayed neurotoxicities

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How to Select and Sequence Therapies in RRMM

Multiple Myeloma at Second or Higher Relapse

(

Combinations with
cyclophosphamide
that do not have
IMiD, Pl, anti-CD38
mAb (eg, KCd)

Anti-BCMA Strategy

Bispecific
Teclistamab
Elranatamab
Investigational on trial
(eg, ABBV-3838,
REGN5458)

CAR T-cell
Cilta-cel
Ide-cel

Belantamab (if available)

|

Existing Drugs
Elotuzumab
Selinexor
Venetoclax
Bendamustine

VDT-PACE

Novel Agents

Talquetamab
Other investigational
agents:

Iberdomide,

mezigdomide
New bispecifics
(cevostamab)
New CAR T-cells,
new mAbs

New ADCs

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Abbreviations and References

Newer Therapeutic Options in “Triple-Class Exposed” RRMM

Abbreviation(s): ADC: antibody-drug conjugate; BCMA: B-cell maturation antigen; BsAb: bispecific antibody;

CAR: chimeric antigen receptor; CD3: cluster of differentiation 3; GPRCSD: G protein-coupled receptor class C group 5
member D; RRMM: relapsed/refractory multiple myeloma.

Reference(s): Chari A et al. N Engl J Med. 2022:387:2232-2244.

Moreau P et al. N Engl J Med. 2022:387:495-505.

San-Miguel J et al. N Engl J Med. 2023;389:335-347.

Munshi NC et al. N Engl J Med. 2021;384:705-716.

Rodriguez-Otero P et al. N Engl J Med. 2023;388:1002-1014.

Lonial $ et al. Lancet Oncol. 2020;21:207-221.

DREAMM-7: BVd vs DVd in RRMM

Abbreviation(s): BVd: belantamab mafodotin (belamaf) plus bortezomib and dexamethasone; CR: complete response;
Dvd: daratumumab plus bortezomib and dexamethasone; MRD: minimal residual disease; ORR: overall/objective
response rate; sCR: stringent CR; VGPR: very good partial response (PR).

Reference(s): Mateos MV et al. 29th European Hematology Association Congress (EHA 2024). Abstract $214,

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Abbreviations and References (Cont'd)

DREAMM-8: BPd vs PVd in RRMM

Abbreviation(s): BPd: belamaf plus pomalidomide and dexamethasone; PVd: pomalidomide plus bortezomib and
dexamethasone.
Reference(s): Dimopoulos MA et al. EHA 2024. Abstract LB3440.

CARTITUDE-4: Cilta-Cel vs SOC in Functional High-Risk MM

Abbreviation(s): DOR: duration of response; LOT: lines of treatment;
of care.
Reference(s): Weisel K et al. EHA 2024. Abstract P959.

E: not evaluable; NR: not reached; SOC: standard

MagnetisMM-3: Elranatamab
lohty M et al. EHA 2024. Abstract P932.

Reference(s):

MajesTEC-1: Teclistamab

Abbreviation(s): CR: complete response.
Reference(s): Sidana S et al. EHA 2024. Abstract P879.

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Abbreviations and References (Cont'd)

MonumenTAL-1 & 2: Talquetamab

Abbreviation(s): mFU: median follow-up; mPFS: median progression-free survival (PFS); Pom: pomalidomide;
Tal: talquetamab; TCR: T-cell redirecting therapies.

Reference(s): Rasche L et al. EHA 2024. Abstract P915.

Searle E et al. EHA 2024. Abstract P9N.

Development/Experimental Therapies

Abbreviation(s): ADC: antibody-drug conjugate; CRS: cytokine release syndrome; DL: dose level; ICANS: immune
effector cell-associated neurotoxicity syndrome.

Reference(s): Touzeau C et al. EHA 2024. Abstract P9I6.

Kumar S et al. EHA 2024. Abstract S210.

Frigault M et al. EHA 2024. Abstract $207.

How to Select and Sequence Therapies in RRMM

Abbreviation(s): IMiD: immunomodulatory drug; mAb: monoclonal antibody; Pl: proteasome inhibitor;
VDT-PACE: bortezomib, dexamethasone, thalidomide, cisplatin, doxorubicin, cyclophosphamide, etoposide.
Reference(s): Rajkumar SV. 16th Annual Clinical Care Options (CCO)/International Myeloma Foundation (IMF)
Hematology Symposium. 2024 Myeloma Treatment Algorithm.

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