-- 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 --
-- Preliminary results from 58 patients
enrolled in the Phase 2 pivotal iMMagine-1 study demonstrated 95%
ORR and 62% CR/sCR at a median follow-up of 10.3 months; additional
patients with a more recent data cut will be presented during an
oral presentation --
-- No delayed neurotoxicities have been
observed to date with anito-cel, including no parkinsonism, no
cranial nerve palsies, and no Guillain-Barré syndrome across the
Phase 1 and iMMagine-1 studies in the more than 140 patients dosed
--
-- First patient dosed in iMMagine-3 study,
manufactured by Kite; turnaround time in line with Kite's
commercial products --
-- Company to host a live webcast event with an
expert panel of clinicians on Monday, December 9, 2024 at 8:30 p.m.
--
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 that it will present clinical data in a
poster presentation from its Phase 1 study (abstract #4825) of
anitocabtagene autoleucel (anito-cel) in patients with relapsed or
refractory multiple myeloma (RRMM); preliminary clinical data in an
oral presentation from its iMMagine-1 study (abstract #1031) in
patients with RRMM; and a health-related quality of life systematic
literature review and meta-analysis (abstract #4721) in patients
with RRMM in a poster presentation at the 66th American Society of
Hematology (ASH) Annual Meeting and Exposition taking place
December 7-10, 2024, in San Diego, California. Additionally, an
abstract (#6962) describing the treatment patterns and outcomes in
triple-class exposed patients with RRMM will be published in a
supplemental issue of Blood in November 2024. The company will also
have a medical affairs booth (#1615) in Hall E of the San Diego
Convention Center.
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)
As detailed in the abstract (#1031) as of June 1, 2024, 58
patients had received anito-cel infusion with ≥2 months of
follow-up after infusion, with a median follow-up of 10.3 months
(range, 2.0-17.8). The median age was 66 years (range, 38-77).
Patients had received a median of four prior lines of treatment
(range, 3-8) with 26 patients (45%) having received only three
prior lines of treatment. Forty patients (69%) were triple-class
refractory and 20 (34%) were penta-class refractory.
Investigator-assessed overall response rate (ORR) per
International Myeloma Working Group (IMWG) criteria was 95% (55/58)
with a complete response/stringent complete response (CR/sCR) rate
of 62% (36/58). Of those evaluable for minimal residual disease
(MRD) testing (n=39), 36 (92%) achieved MRD negativity at least to
the level of 10-5. The Kaplan–Meier-estimated 6-month
progression-free survival (PFS) and overall survival (OS) rates
(95% CI) were 90% (77-96) and 95% (85-98), respectively. Median
(mPFS) and median OS have not yet been reached.
No delayed neurotoxicities, including no parkinsonism, no
cranial nerve palsies, and no Guillain-Barré syndrome have been
observed to date. Forty-six patients (79%) had either no cytokine
release syndrome (CRS) (n=9, 16%) or Grade (Gr) 1 CRS (n=37, 64%).
Thirty-one patients (53%) had no fever or CRS in the first four
days of anito-cel. Any Grade CRS was observed in 49 patients (84%;
Gr3/4 0%). Any Grade ICANS was observed in 5 patients (9%; Gr3 2%),
with all cases resolved without sequelae. Three deaths occurred due
to adverse events (AEs) (both related and unrelated;
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 treatment-emergent AEs; 36 patients (62%) had Grade ≥3
neutropenia, 15 (26%) had Grade ≥3 thrombocytopenia, and 15 (26%)
had Grade ≥3 anemia.
Conclusions
Preliminary results from the first 58 patients in the Phase 2
iMMagine-1 study demonstrate deep and durable responses and
manageable safety in a high-risk fourth line or higher (4L+) RRMM
population including triple- and penta-class refractory disease.
Notably, no delayed neurotoxicities, including no cranial nerve
palsies, Guillain-Barré syndrome, or Parkinsonian-like symptoms
have been observed with anito-cel to date. Updated Phase 2 data
with a more recent data cut will be presented at the oral
presentation during ASH.
Presentation
details:
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.
Presentation Time: 5:30 p.m.
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)
In the Phase 1 study, 40 patients were enrolled and 38 patients
received anito-cel. All 38 patients demonstrated
investigator-assessed clinical response per 2016 IMWG criteria,
(ORR, 100%) with 30 CR/sCR (≥CR rate, 79%), 5 very good partial
response (≥VGPR rate, 92%), and 3 partial response (PR). Of those
evaluable for MRD testing (n=28), 25 (89%) achieved MRD negativity
at 10-5. With a median follow-up of 38.1 months, median OS was not
reached and median PFS was 30.2 months. The safety profile was
manageable with no delayed neurotoxicities observed to date,
including no parkinsonism, no cranial nerve palsies, and no
Guillain-Barré syndrome. Further investigations of anito-cel are
ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines
(iMMagine-3, NCT06413498).
Presentation
details:
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.
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)
Quantifying pre-treatment HRQoL burden is important as a
reference for contextualizing baseline patient burden as emerging
therapies for RRMM continue to evolve. This SLR synthesized studies
that reported data for key multiple myeloma HRQoL instruments. It
found that patients with RRMM had clinically meaningful impairments
from population norms in important domains, such as Global Health
Status and cognitive, physical, and emotional functioning. The SLR
also found that pre-treatment HRQoL worsened with increasing lines
of therapy.
Presentation
details:
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.
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)
In order to understand the contemporary unmet need in the
rapidly evolving treatment landscape for patients with triple-class
exposed RRMM - those exposed to immunomodulatory drugs, proteasome
inhibitors, and anti-CD38 monoclonal antibodies - in the 4L+
setting, a retrospective cohort study using the Flatiron Health
electronic health record (HER) was conducted (sample size=594).
This study found no clear standard of care in the 4L+ setting, and
suboptimal health outcomes under the current treatment landscape
(ORR=34%, PFS=4.1 months, and OS=15.4 months), emphasizing an
urgent need for more effective and durable therapies for patients
in this setting.
This abstract will be published in a supplemental issue of Blood
in November 2024.
Webcast Event:
Arcellx will host a live webcast event with an expert panel of
clinicians to discuss the clinical results on Monday, December 9,
2024 at 8:30 p.m. PT. The event will be accessible from Arcellx's
website at www.arcellx.com in the Investors section. 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. 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 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 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 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 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 Arcellx’s
plans for the clinical development of its product candidates;
anticipated announcements of additional data; anito-cel
tolerability and toxicity trends; Arcellx’s competitive
positioning; expectations regarding manufacturing time; the
potential commrical launch of anito-cel, subject to FDA approval;
and the potential impact of Arcellx’s product candidates and
platforms on patients and cell therapy. 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 June 30, 2024, filed with the Securities and Exchange
Commission (SEC) on August 8, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241104656062/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
Arcellx (NASDAQ:ACLX)
過去 株価チャート
から 11 2024 まで 12 2024
Arcellx (NASDAQ:ACLX)
過去 株価チャート
から 12 2023 まで 12 2024
