Allogene Therapeutics Provides Additional ALLO-501/501A Phase 1 Data in an Oral Presentation at the International Conference on Malignant Lymphoma (ICML) Lugano
15 Junho 2023 - 10:30AM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) products for cancer, today at the International
Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland
presented updated data from the Phase 1 ALPHA/ALPHA2 trials of
ALLO-501/501A in 33 CAR T naïve patients with relapsed/refractory
(r/r) large B-cell lymphoma (LBCL) treated with the Alloy™
manufacturing process material across different CAR T dosing and
lymphodepletion regimens. Earlier in June, data from the 12
patients, a subset of these 33 CAR T naïve patients, who received
regimen being utilized in ongoing Phase 2 trials was presented at
American Society of Clinical Oncology (ASCO) Annual Meeting.
“We believe these data provide strong support for the ability of
our product candidates to induce durable complete remissions at a
rate similar to approved autologous CD19 CAR T therapies,” said
Zachary Roberts, M.D., Ph.D., Executive Vice President, Research
& Development and Chief Medical Officer. “The design and
execution of our Phase 1 ALPHA/ALPHA 2 trials enabled a systematic
evaluation of potential Phase 2 treatment regimens. Based on these
data, we were able to select an optimal dosing regimen that we
believe will be capable of delivering the benefit of CAR T
treatment to patients without the lengthy wait time and risk of
manufacturing failure associated with autologous CAR T. We have now
turned our attention to enrolling our potentially pivotal Phase 2
trials as quickly as possible.”
The updated analysis (data cutoff April 20, 2023) of
ALPHA/ALPHA2 examined data from all 33 CAR T-naïve patients with
r/r LBCL who were treated with a single infusion or consolidation
therapy (two planned infusions) of ALLO-501/501A manufactured using
the Alloy™ manufacturing process. Patients received lymphodepletion
with fludarabine (30 mg/m2/day x 3 days) and cyclophosphamide (300
mg/m2/day x 3 days) and varying doses of ALLO-647 (from 13
mg/day to 30 mg/day x 3 days).
The median time from enrollment to the start of therapy was
three days and 100% of patients received product per
specifications. No patients received bridging therapy. The dosing
breakdown for the 33 patients included in this data set is as
follows:
- 12 patients treated with a single dose of ALLO-501/501A and
FCA90 lymphodepletion (Phase 2 regimen; recap of the ASCO 2023 data
presentation)
- 6 patients treated with a single dose of ALLO-501/501A and
FCA<90 lymphodepletion
- 15 patients treated with consolidation dosing of ALLO-501/501A
and split lymphodepletion
|
CAR T- Naïve Patients with r/r LBCLAlloy Manufacturing Process |
|
All(N=33) |
Phase 2Regimen (N=12) |
FCA<90(N=6) |
ConsolidationDosing (N=15) |
Overall Response Rate (ORR), n (%) |
19 (58) |
8 (67) |
3 (50) |
8 (53) |
Complete Response Rate (CR), n (%) |
14 (42) |
7 (58) |
1 (17) |
6 (40) |
6 Month Complete Response, n (%) |
10 (30) |
5 (42) |
0 |
5 (33) |
Seven of 12 (58%) patients receiving the Phase 2 regimen
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. Across all 33 patients the CR rate
was 42% with 30% maintaining a CR at Month 6. These results
indicate complete responses are more common with lymphodepletion
regimens containing 90 mg of ALLO-647 (FCA90). Median duration of
response for both the overall population (n=33) and the patients
treated with the Phase 2 regimen (n=12) was 23.1 months.
|
CAR T- Naïve Patients with r/r LBCL |
|
All(N=33) |
Phase 2Regimen (N=12) |
FCA<90(N=6) |
Consolidation(N=15) |
All GrN (%) |
Gr 3+N (%) |
All GrN (%) |
Gr 3+N (%) |
All GrN (%) |
Gr 3+N (%) |
All GrN (%) |
Gr 3+N (%) |
CRS |
8 (24) |
0 |
4 (33) |
0 |
1 (17) |
0 |
3 (20) |
0 |
Neurotoxicity |
13 (39) |
2 (6) |
4 (33) |
0 |
2 (33) |
0 |
7 (47) |
2 (13) |
ICANS |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
GvHD |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRR |
16 (49) |
3 (9) |
8 (67) |
0 |
3 (50) |
1 (17) |
5 (33) |
2 (13) |
Infection |
19 (58) |
5 (15) |
8 (67) |
1 (8) |
3 (50) |
1 (17) |
8 (53) |
3 (20) |
Prolonged Gr3+ Cytopenia |
- |
4 (12) |
- |
2 (17) |
- |
0 |
- |
2 (13) |
Across the 33 patients, 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. Cytopenia 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 multiple 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. The Company
expects to open trial sites in Europe, Canada and Australia during
2023.
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 “could,” “designed,”
“expects,” “potential,” “preliminary,” “will” 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 product candidates to
generate durable complete responses similar to approved autologous
therapies; the potential of the Phase 2 ALPHA2 trial to be a
pivotal trial; Allogene’s expectation to complete enrollment of the
Phase 2 ALPHA2 trial in the first half of 2024; Allogene’s
expectation to open trial sites for the Phase 2 ALPHA2 trial in
Europe, Canada and Australia during 2023; the design of Allogene’s
trials and ALLO-647; data results that may be implied from prior
results; and the potential benefits of AlloCAR T products. Various
factors may cause material differences between Allogene’s
expectations and actual results, including, risks and uncertainties
related to: our 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 our 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; our ability to maintain intellectual
property rights necessary for the continued development of our
product candidates, including pursuant to our license agreements;
our 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 our
business, including our clinical trials; the extent to which
the FDA disagrees with our clinical or regulatory plans,
which could cause future delays to our clinical trials or require
additional clinical trials; we may encounter difficulties enrolling
patients in our clinical trials; we may not be able to demonstrate
the safety and efficacy of our product candidates in our clinical
trials, which could prevent or delay regulatory approval and
commercialization; challenges with manufacturing or optimizing
manufacturing of our product candidates; and our ability to obtain
additional financing to develop our products and implement our
operating plans. These and other risks are discussed in greater
detail in Allogene’s filings with the SEC, including without
limitation under the “Risk Factors” heading of its Form 10-Q 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
products 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.
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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