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1

iMMagine-3 Trial to initiate 2H 2024 with Kite Best-in-Class Manufacturing

Multi-center, Global, Phase 3 Randomized Control Clinical Trial (RCT) for

anti-CD38 mAb and IMiD exposed patients

  • Addressing the largest percentage of second line (2L) patients as anti-CD38 mAbs become standard of care in front line (1L)
    o Covers $12B relapsed refractory Multiple Myeloma market
  • Anticipate high physician interest in iMMagine-3 based on:
    1. Potential best-in-class product profile o Relevant standard of care alternatives
      o Rapid and reliable turnaround time with Kite manufacturing
  • Easy to identify patient population, expected to streamline access to anito-cel
  • Confirmatory RCT will include ~450 patients randomized 1:1 in US and Intl sites

2

Use of an Anti-CD38 and IMiD are standard of care in frontline regimens for

Multiple Myeloma

Number of 1L MM patients treated with Anti-

CD38 by year

80%

~75%

70%

60%

~60%

50%

40%

30%

20%

10%

~10%

0%

2020A

2025E

2028E

Anti-CD38 based regimens in

1L have demonstrated strong results1,2 and are now used as standard of care

High uptake of anti-CD38 in the near term will translate to large

2L population that is anti- CD38 exposed in the future

1. Phase 3 PERSEUS study (NCT03710603); 2. Phase 3 MAIA study (NCT02252172);

3

Sources: Komodo Claims Analysis, June 2023; market research, internal analyses, estimates and projections by Kite and Arcellx

iMMagine-3 Captures Largest Anticipated 2L Population

  • of Projected Steady State 2L On Label CAR T Patient Population by Segment1

~5% Unique to

Other CAR T in 2L

~35% Shared in 2L

~35% Unique to

anito-cel in 2L

5%

Len. Refractory and PI Exposed Only

35%

Anti-CD38 and PI Exposed,

and Len. Refractory

35%

Anti-CD38 and IMiD Exposed,

not Len. Refractory

~70%

of 2L patients projected to be

Anti-CD38 + IMiD exposed

~93%

anito-cel coverage (70% of 75% On

Label 2L CAR T patients)

1. Steady state epidemiology assumptions for 2L patient population assumes 2030+

4

Source: Market research, internal analyses, estimates and projections by Kite and Arcellx

iMMagine-3 Global Phase 3 Randomized Study of Anti-CD38 + IMiD Exposed Patients

Screening

/ Randomization

Leukapheresis

Therapya

Bridging

Lymphodepleting

Chemotherapy

Anito-cel Arm

Target dose: 115 (± 10) x 106 CAR+ T cells

Follow-up

Enrollment

Standard of Care Armb

KDd, PVd, DPd, Kd

STUDY DESIGN

STUDY ENDPOINTS

•

1:1 Randomization

•

Primary Endpoint: PFS

•

n = Approximately 450, ~130 sites globally

•

Key Secondary Endpoints: CR rate, MRD, OS, safety

a Optional Bridging therapy will be the SOC regimen selected prior to randomization

5

b Cycles will continue until unacceptable toxicity, progression as per IMWG criteria, or patient withdrawal of consent

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Arcellx Inc. published this content on 09 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 May 2024 01:58:07 UTC.