-- Preliminary results from 86 patients
enrolled in the Phase 2 pivotal iMMagine-1 study of anito-cel
demonstrated 97% ORR and 62% CR/sCR at a median follow-up of 9.5
months --
-- No delayed neurotoxicities have been
observed to date with anito-cel, including no Parkinsonism, no
cranial nerve palsies, and no Guillain-Barré syndrome in more than
150 patients dosed across the Phase 1 and iMMagine-1 studies --
-- 30.2-month median progression-free survival
with a median follow-up of 38.1 months in the Phase 1 study of
anito-cel; median overall survival not reached --
-- Company highlights additional presentations
during the ASH Annual Meeting --
-- Company to host a live webcast event with an
expert panel of clinicians on Monday, December 9, 2024 at 8 p.m. PT
--
Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company
reimagining cell therapy through the development of innovative
immunotherapies for patients with cancer and other incurable
diseases, today announced new positive data from its Phase 2
pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel),
in patients with relapsed or refractory multiple myeloma (RRMM).
These data will be presented during an oral presentation at the
66th American Society of Hematology (ASH) Annual Meeting and
Exposition on Monday, December 9, 2024 at 5:30 p.m. PT. Anito-cel
is partnered with Kite, a Gilead Company. Additional presentations
during ASH are also noted below.
The Phase 2 iMMagine-1 data are from an October 31, 2024 data
cutoff date, with a median follow-up of 9.5 months for the efficacy
evaluable population. At the time of the data cut, 86 patients were
evaluable for efficacy based on a follow-up of at least two months
after treatment with anito-cel, and 98 patients were evaluable for
safety based on a follow-up of at least one month after treatment
with anito-cel. All patients received a single infusion of
anito-cel (target dose of 115×106 CAR+ viable T cells). In the
safety evaluable population, 85 of 98 patients (87%) were triple
refractory, and 41 of 98 patients (42%) were penta refractory.
Patients received a median of four prior lines of therapy, with 45
of 98 patients (46%) having received three prior lines.
Overall response rate (ORR) was 97% (83/86) with a complete
response/stringent complete response (CR/sCR) rate of 62% (53/86)
and a very good partial response or higher (>VGPR) rate of 81% (70/86), per International
Myeloma Working Group (IMWG) criteria as investigator-assessed. Of
those evaluable for minimal residual disease (MRD) testing, 93.1%
(54/58) achieved MRD negativity at a minimum of 10-5 sensitivity.
Median progression-free survival (mPFS) and overall survival (OS)
were not reached; 6-month PFS and OS rates were 93.3% and 96.5%,
respectively, and 12-month PFS and OS rates were 78.5% and 96.5%,
respectively.
No delayed or non-ICANS neurotoxicities, including no
Parkinsonism, no cranial nerve palsies, and no Guillain-Barré
syndrome, have been observed to date in more than 150 patients
dosed with anito-cel. Of the safety evaluable population, 86%
(84/98) had Grade ≤1 cytokine release syndrome (CRS), including 17%
of patients with no CRS. Among patients experiencing CRS, the
median onset was four days (range: 1-17 days). Eight percent of
patients (8/98) were treated as outpatient. Ninety-one percent
(89/98) of patients had no ICANS. Any Grade ICANS was observed in 9
patients (9%; Gr3 1%), with all cases resolved without sequelae.
Three deaths occurred due to treatment-emergent adverse events
(TEAEs) (related or unrelated to anito-cel: retroperitoneal
hemorrhage, CRS, and fungal infection). No additional treatment or
therapy-related deaths or Grade ≥3 CRS or ICANs events have
occurred to date. Cytopenias were the most common Grade ≥3 TEAEs;
53 patients (54%) had Grade ≥3 neutropenia, 20 (20%) had Grade ≥3
thrombocytopenia, and 22 (22%) had Grade ≥3 anemia.
Conclusions
Preliminary results from the Phase 2 iMMagine-1 study
demonstrate deep and durable responses with a predictable and
manageable safety profile in a high-risk fourth-line or higher
(4L+) RRMM population, including triple- and penta-class refractory
disease. Notably, no delayed or non-ICANS neurotoxicities,
including no Parkinsonism, no cranial nerve palsies, and no
Guillain-Barré syndrome, have been observed with anito-cel to
date.
Ciara Freeman, M.D., Ph.D., Assistant Member, Department of
Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt
Cancer Center said, “The data from the iMMagine-1 study demonstrate
that this is a highly active product with impressive depth of
responses achieved in patients with relapsed or refractory multiple
myeloma. As a physician who treats many patients both inpatient and
in the outpatient setting, the emerging safety profile of anito-cel
is encouraging, in particular the absence of any delayed
neurotoxicities reported to date. We are excited to begin enrolling
patients in the iMMagine-3 study and in the near future having
anito-cel as an approved treatment option.”
Arcellx’s Chairman and Chief Executive Officer, Rami Elghandour,
said, “It’s exciting to reach this momentous milestone in our
pivotal study and present these compelling data. These data, along
with the data from our Phase 1 study, which demonstrated a
30.2-month median PFS and zero cases of delayed neurotoxicity or
other non-ICANS neurotoxicity with all patients having more than
two years of follow-up, continue to support our conviction that
anito-cel has the potential to be a best-in-class treatment option
for patients with RRMM. Additionally, with iMMagine-3 underway in
earlier lines in a patient population representing an unmet
clinical need, we expect to further position anito-cel as a
differentiated CAR-T treatment option for RRMM. Separately, this
year is Arcellx’s 10th anniversary! I’m grateful for the incredible
people who make up the fabric of Arcellx and have poured themselves
into developing this life-saving therapy for the patients most in
need. And I'm proud of how we’ve done it, leaning into our
diversity as a cornerstone of our culture, which underpins our
success. I especially appreciate the partnership, collaboration,
and trust of the Phase 1 and iMMagine-1 clinicians who helped
enroll patients in these studies and allowed us to demonstrate the
potential benefit of anito-cel. I’m also grateful to those who
believed in us, our founding investors and scientists, our
investors who helped us go public nearly three years ago in a
challenging market, and those who have joined us along the way. To
our colleagues at Kite, we thank you for your partnership. To
everyone who’s been part of this incredible journey, thank you!
We’re just getting started!”
ASH Presentation Details
Phase 2 Registrational Study of Anitocabtagene Autoleucel for
the Treatment of Patients with Relapsed and/or Refractory Multiple
Myeloma: Preliminary Results From the iMMagine-1 Trial (abstract
#1031)
Speaker: Ciara Freeman, M.D., Ph.D., H. Lee Moffitt
Cancer Center Session Name: 655. Multiple Myeloma: Cellular
Therapies: Unleashing Cell Therapies Against Myeloma Session
Date: Monday, December 9, 2024 Session Time: 4:30 p.m. -
6:00 p.m. PT Presentation Time: 5:30 p.m. PT
Location: Marriott Marquis San Diego Marina, Pacific
Ballroom Salons 24-26 Publication Number: 1031 Submission
ID: 198499
Phase 1 Study of Anitocabtagene Autoleucel for the Treatment
of Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
(abstract #4825)
Speaker: Michael R. Bishop, M.D., The University of
Chicago Session Name: 704. Cellular Immunotherapies: Early
Phase Clinical Trials and Toxicities Session Date: Monday,
December 9, 2024 Presentation Time: 6:00 p.m. - 8:00 p.m. PT
Location: San Diego Convention Center, Halls G-H
Publication Number: 4825 Submission ID: 201080
Health Related Quality of Life (HRQoL) in Relapsed/Refractory
Multiple Myeloma (RRMM): A Systematic Literature Review (SLR) and
Meta-Analysis (abstract #4721)
Speaker: Rahul Banerjee, M.D., Fred Hutchinson Cancer
Center Session Name: 653. Multiple Myeloma: Clinical and
Epidemiological: Poster III Session Date: Monday, December
9, 2024 Presentation Time: 6:00 p.m. - 8:00 p.m. PT
Location: San Diego Convention Center, Halls G-H
Treatment Patterns and Outcomes in Triple-Class Exposed
Patients with Relapsed and Refractory Multiple Myeloma: Findings
from the Flatiron Database (abstract #6962)
This abstract will be published in a supplemental issue of Blood
in November 2024.
Webcast Event (New Start
Time):
Arcellx will host a live webcast event with an expert panel of
clinicians to discuss the clinical results on Monday, December 9,
2024 at 8 p.m. PT. The event will be accessible from the Investors
section of the Company’s website at ir.arcellx.com. A webcast
replay will be archived and available for 30 days following the
event.
About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which
diseased plasma cells proliferate and accumulate in the bone
marrow, crowding out healthy blood cells and causing bone lesions,
loss of bone density, and bone fractures. These abnormal plasma
cells also produce excessive quantities of an abnormal
immunoglobulin fragment, called a myeloma protein (M protein),
causing kidney damage and impairing the patient’s immune function.
Multiple myeloma is the third most common hematological malignancy
in the United States and Europe, representing approximately 10% of
all hematological cancer cases and 20% of deaths due to
hematological malignancies. The median age of patients at diagnosis
is 69 years with one-third of patients diagnosed at an age of at
least 75 years. Because MM tends to afflict patients at an advanced
stage of life, patients often have multiple co-morbidities and
toxicities that can quickly escalate and become
life-endangering.
About Anitocabtagene Autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the
first BCMA-directed CAR T-cell therapy to be investigated in
multiple myeloma that utilizes Arcellx’s novel and compact binder
known as the D-Domain. The small, stable D-Domain binder enables
high CAR expression without tonic signaling and is designed to
quickly release from the BCMA target. This combination may allow
for the effective elimination of multiple myeloma cells without
severe immunotoxicity. Anito-cel has been granted Fast Track,
Orphan Drug, and Regenerative Medicine Advanced Therapy
Designations by the U.S. Food and Drug Administration.
About iMMagine-3, A Global Phase 3 Randomized Controlled
Clinical Study
iMMagine-3 is a global Phase 3 randomized controlled study
designed to compare the efficacy and safety of anitocabtagene
autoleucel (anito-cel) with standard of care in patients with
relapsed and/or refractory multiple myeloma (RRMM) who have
received one to three prior lines of therapy, including an
immunomodulatory drug (lMiD) and an anti-CD38 monoclonal
antibody.
iMMagine-3 will enroll approximately 450 adult patients. Prior
to randomization, investigator’s choice of standard of care (SOC)
regimens include: pomalidomide, bortezomib, and dexamethasone
(PVd); daratumumab, pomalidomide, and dexamethasone (DPd);
carfilzomib, daratumumab, and dexamethasone (KDd); or carfilzomib
and dexamethasone (Kd). Patients in the anito-cel arm will undergo
leukapheresis and optional bridging therapy (with the SOC regimen
selected by the investigator prior to randomization) followed by
lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and
cyclophosphamide 300 mg/m2/d for 3 days) and one infusion of
anito-cel (115×106 CAR+ T cells) on Day 1.
The primary endpoint is progression-free survival (PFS) per
blinded independent review according to the 2016 IMWG uniform
response criteria for multiple myeloma (MM) with the hypothesis
that anito-cel will prolong PFS compared to SOC. Key secondary
endpoints include complete response rate (CR/sCR), minimal residual
disease negativity, overall survival, and safety.
The iMMagine-3 study was initiated in the second half of 2024 at
approximately 130 study sites across North America, Europe, and the
rest of the world.
About Arcellx and Kite Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic
collaboration and license agreement to co-develop and
co-commercialize anito-cel for patients with relapsed and/or
refractory multiple myeloma, (RRMM). Anito-cel is currently being
developed in a Phase 2 registrational pivotal study and a global
Phase 3 randomized controlled study for RRMM. Kite and Arcellx will
jointly commercialize the anito-cel asset in the United States, and
Kite will commercialize the product outside the United States.
About Arcellx, Inc.
Arcellx, Inc. is a clinical-stage biotechnology company
reimagining cell therapy by engineering innovative immunotherapies
for patients with cancer and other incurable diseases. Arcellx
believes that cell therapies are one of the forward pillars of
medicine and Arcellx's mission is to advance humanity by developing
cell therapies that are safer, more effective, and more broadly
accessible. For more information on Arcellx, please visit
www.arcellx.com. Follow Arcellx on X @arcellx and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. All statements in this press release that are not purely
historical are forward-looking statements, including, but not
limited to, statements regarding the safety and efficacy of
anito-cel, the promising clinical profile of anito-cel, the
expectation of anito-cel to be a differentiated CAR-T treatment
option for RRMM, the potential of anito-cel as an outpatient
therapy, the potential of anito-cel to be a best-in-class treatment
option for patients with RRMM, or the planned commercial
development of anito-cel both inside and outside the United States;
and the enrollment of patients in the iMMagine-3 study. The
forward-looking statements contained herein are based upon
Arcellx’s current expectations and involve assumptions that may
never materialize or may prove to be incorrect. These
forward-looking statements are neither promises nor guarantees and
are subject to a variety of risks and uncertainties, including
those set forth in Part II, Item 1A (Risk Factors) in the Quarterly
Report on Form 10-Q for the quarter ended September 30, 2024, filed
with the Securities and Exchange Commission (SEC) on November 7,
2024, and the other documents that Arcellx may file from time to
time with the Securities and Exchange Commission. These
forward-looking statements are made as of the date of this press
release, and Arcellx assumes no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20241208772135/en/
Investor Contact: Myesha Lacy Arcellx, Inc.
ir@arcellx.com 510-418-2412
Media Contact: Andrea Cohen Sam Brown Inc.
andreacohen@sambrown.com 917-209-7163
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