Allogene Therapeutics Presents Updated ALLO-501/501A Phase 1 Data in Large B Cell Lymphoma at the American Society of Clinical Oncology (ASCO) Annual Meeting
03 Junho 2023 - 10:00AM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer, today presented long-term
follow up data from the Phase 1 ALPHA/ALPHA2 trials of
ALLO-501/501A in patients with relapsed/refractory (r/r) large
B-cell lymphoma (LBCL) at the American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago, Illinois. These data will also be
presented in a poster session at the European Hematology
Association (EHA) Hybrid Congress on June 9, 2023.
“We are excited to be the first to demonstrate the potential of
allogeneic CD19 CAR T to induce durable complete remissions at a
rate similar to approved autologous CD19 CAR T therapies. Our Phase
2 regimen also had a safety profile, including immune recovery, in
line with approved options,” said Zachary Roberts, M.D., Ph.D.,
Executive Vice President, Research & Development and Chief
Medical Officer. “We believe our AlloCAR T product candidates have
the potential to break down widespread access barriers to CAR T,
and ultimately establish a new paradigm in cell therapy. These data
underlie the excitement we and investigators have for our ongoing
potentially pivotal Phase 2 ALPHA2 trial.”
The updated analysis of ALPHA/ALPHA2 examined data from 12 CAR
T-naïve patients with r/r LBCL who received a single dose of
ALLO-501/501A manufactured using the Alloy™ process following a
lymphodepletion regimen (FCA90) comprised of fludarabine (30
mg/m2/day x 3 days) and cyclophosphamide (300 mg/m2/day x 3 days)
plus ALLO-647 (30 mg/day x 3 days). The median time from enrollment
to the start of therapy was three days and all 12 patients were
followed through a minimum of six months (data cutoff April 20,
2023).
|
Patients Treated with Phase 2 Regimen(n=12) |
Overall Response Rate (ORR), n (%) |
8 (67) |
Complete Response Rate (CR), n (%) |
7 (58) |
6 Month Complete Response, n (%) |
5 (42) |
As of the data cutoff, 7 of 12 (58%) patients achieved a CR and
five (42%) maintained a CR through Month 6. Of the five patients
who were in CR at 6 months, four (80%) remained in CR. The fifth
patient had disease progression at 24 months. The median duration
of response was 23.1 months with three patients remaining in
remission for over 24 months and the longest remaining in remission
for over 31 months.
|
All r/r CAR T naïve LBCL (N=33) |
Patients Treated with Phase 2 Regimen (N=12) |
All GrN (%) |
Gr 3+N (%) |
All GrN (%) |
Gr 3+N (%) |
CRS |
8 (24) |
0 |
4 (33) |
0 |
ICANS |
0 |
0 |
0 |
0 |
Neurotoxicity |
13 (39) |
2 (6) |
4 (33) |
0 |
GvHD |
0 |
0 |
0 |
0 |
IRR |
16 (49) |
3 (9) |
8 (67) |
0 |
Infection |
19 (58) |
5 (15) |
8 (67) |
1 (8) |
Prolonged Gr3+ Cytopenia |
- |
4 (12) |
- |
2 (17) |
A safety analysis of 33 CAR T-naïve LBCL patients receiving
Alloy™ process ALLO-501/501A product candidates at any dose and
lymphodepletion schedule, including the 12 patients treated with
the Phase 2 regimen, was also conducted. Treatment was generally
well tolerated with no incidences of Grade 3 or greater cytokine
release syndrome, and no cases of immune effector cell-associated
neurotoxicity syndrome or graft versus host disease. Cytopenias and
infections were manageable and comparable to the experience with
autologous CAR T cell therapies in patients with r/r LBCL.
The ALPHA/ALPHA2 Phase 1 trials were designed to assess the
safety, tolerability, and preliminary efficacy at increasing dose
levels of ALLO-501 and ALLO-501A, allogeneic CAR T cell product
candidates that target CD19. In addition to exploring cell doses,
these studies evaluated various doses of ALLO-647, Allogene’s
proprietary lymphodepleting antibody designed to prevent premature
rejection of AlloCAR T cells. Allogene is currently enrolling the
potentially pivotal Phase 2 ALPHA2 trial of ALLO-501A in LBCL and
expects to complete enrollment in 1H2024.
About ALLO-501 and ALLO-501AALLO-501 and
ALLO-501A are anti-CD19 AlloCAR T investigational products for the
treatment of large B cell lymphoma. ALLO-501A, a next-generation
anti-CD19 AlloCAR T, eliminates the rituximab recognition domains
in ALLO-501, which could allow for use in a broader patient
population, including NHL patients with recent rituximab exposure.
This product candidate is currently being studied in an ongoing
potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and
Drug Administration granted Regenerative Medicine Advanced Therapy
(RMAT) designation to ALLO-501A in r/r LBCL.
About Allogene TherapeuticsAllogene
Therapeutics, with headquarters in South San Francisco, is a
clinical-stage biotechnology company pioneering the development of
allogeneic chimeric antigen receptor T cell (AlloCAR T™) products
for cancer. Led by a management team with significant experience in
cell therapy, Allogene is developing a pipeline of “off-the-shelf”
CAR T cell candidates with the goal of delivering readily available
cell therapy on-demand, more reliably, and at greater scale to more
patients. For more information, please visit www.allogene.com and
follow @AllogeneTx on Twitter and LinkedIn.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements for purposes of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. The press release
may, in some cases, use terms such as "predicts," "believes,"
"potential," "proposed," "continue," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "will,"
"should" or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the potential of allogeneic CD19
CAR T to generate durable complete responses similar to approved
autologous therapies; ALPHA2 being a potentially pivotal trial;
expected completion of enrollment in ALPHA2 in the first half of
2024; the potential safety profile of Allogene’s Phase 2
lymphodepletion and cell dose regimen; the potential of Allogene’s
AlloCAR T product candidates to break down access barriers to CAR 2
and establish a new paradigm in cell therapy; and the potential
benefits of the Alloy process and AlloCAR T products. Various
factors may cause material differences between Allogene’s
expectations and actual results, including risks and uncertainties
related to: Allogene’s product candidates are based on novel
technologies, which makes it difficult to predict the time and cost
of product candidate development and obtaining regulatory approval;
Phase 1 data from Allogene’s clinical trials is limited and may
change as more patient data become available or may not be
validated in any future or advanced clinical trial; Allogene’s
ability to maintain intellectual property rights necessary for the
continued development of its product candidates, including pursuant
to its license agreements; Allogene’s product candidates may cause
undesirable side effects or have other properties that could halt
their clinical development, prevent their regulatory approval or
limit their commercial potential; the extent to which COVID-19
adversely impacts Allogene’s business, including its clinical
trials; the extent to which the FDA disagrees with
Allogene’s clinical or regulatory plans, which could cause future
delays to Allogene’s clinical trials or require additional clinical
trials; Allogene may encounter difficulties enrolling patients in
its clinical trials; Allogene may not be able to demonstrate the
safety and efficacy of its product candidates in its clinical
trials, which could prevent or delay regulatory approval and
commercialization; challenges with manufacturing or optimizing
manufacturing of Allogene’s product candidates; and Allogene’s
ability to obtain additional financing to develop its products and
implement its operating plans. These and other risks are discussed
in greater detail in Allogene’s filings with the SEC, including
without limitation in its Form 10-Q filed for the quarter ended
March 31, 2023. Any forward-looking statements that are made in
this press release speak only as of the date of this press release.
Allogene assumes no obligation to update the forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Caution should be exercised regarding statements comparing
autologous CAR T data. There are differences in the clinical trial
design, patient populations, published data, follow-up times and
the product candidates themselves, and the results from the
clinical trials of autologous products may have no interpretative
value on Allogene’s existing or future results.
AlloCAR T™ and Alloy™ are trademarks of Allogene Therapeutics,
Inc.
Allogene’s AlloCAR T™ programs utilize the Cellectis TALEN®
technologies. ALLO-501 and ALLO-501A are anti-CD19 product
candidates being jointly developed under a collaboration agreement
between Servier and Allogene based on an exclusive license granted
by Cellectis to Servier. Servier grants to Allogene exclusive
rights to ALLO-501 and ALLO-501A in the U.S. with an option for
exclusive rights for all other countries.
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
Additional Allogene Media Contact:Madeleine
GoldsteinManager, Corporate & Pipeline
CommunicationsMadeleine.Goldstein@allogene.com
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