Real-World Results Demonstrate Objective
Response Rate (ORR) of 67% in 24 EBV+ PTLD Patients
91% Overall Survival (OS) at One Year for
Patients Responding to Tab-cel Compared to 34% for
Non-Responders
Tab-cel Safety Profile Consistent with Phase 3
ALLELE Study Findings
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell
immunotherapy, leveraging its novel allogeneic Epstein-Barr virus
(EBV) T-cell platform to develop transformative therapies for
patients with cancer and autoimmune diseases, today announced
updated effectiveness and safety data for tabelecleucel (tab-cel®
or EBVALLO™) from the multicenter Expanded Access Program (EAP)
study in Europe. The results will be featured in a poster
presentation at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting taking place June 2-6 in Chicago.
Atara supported 27 EAP requests in Europe for patients with
relapsed or refractory (r/r) Epstein-Barr virus-positive
post-transplant lymphoproliferative disease (EBV+ PTLD) following
solid organ transplant (SOT) or hematopoietic cell transplant
(HCT). 24 EBV+ PTLD patients, 16 SOT recipients and eight HCT
recipients, consented to use of data and received at least one dose
of tab-cel, including four patients with EBV+ primary central
nervous system (PCNS) PTLD.
An objective response rate (ORR) of 66.7% (16/24) was observed
for both SOT and HCT groups (95% CI: 44.7, 84.4), 56.3% (9/16) for
patients following SOT (95% CI: 29.9, 80.2) and 87.5% (7/8) for HCT
patients (95% CI: 47.3, 99.7) with a best overall response of
Complete Response (CR; 33.3%; n=4, SOT, n=4, HCT) or Partial
Response (PR; 33.3%; n=5, SOT, n=3, HCT).
"These real-world results affirm the favorable risk-benefit
profile seen in the pivotal Phase 3 ALLELE study which supported
tab-cel as the first-ever allogeneic T-cell immunotherapy
approved," said AJ Joshi, MD, Chief Medical Officer at Atara.
"Tab-cel was well tolerated and delivered a one-year survival rate
of nearly 91% in responders, reinforcing its potential to address
an urgent unmet medical need for EBV+ PTLD patients.”
The median time to response (TTR) in all patients was 1.0 month
(range: 0.8–2.2). Of the subgroup of patients with EBV+ PCNS PTLD,
three out of four (75%; 95% CI: 19.4, 99.4) treated patients
achieved a response with one CR and two PRs.
One-year survival rates were 73.7% (95% CI: 47.3, 88.3) across
both groups, 66.5% for SOT patients (95% CI: 32.7, 86.2) and 87.5%
for HCT patients (95% CI: 38.7, 98.1). EBV+ PTLD patients
responding to tab-cel had longer one-year survival compared to the
non-responders, with a one-year survival rate of 90.9% (95% CI:
50.8, 98.7) versus 34.3% (95% CI: 4.8, 68.5) for
non-responders.
“These data provide important insights on the effectiveness of
EBVALLO™ in the real-world treatment setting,” said Dr. Sylvain
Choquet, Head of the Clinical Hematology Department at
Pitié-Salpêtrière, Paris, France. “Findings further reinforce the
clinical profile already established for EBVALLO™, underscoring its
potential as new treatment option for an ultra-rare and highly
aggressive form of lymphoma that occurs in some transplant
patients.”
Safety findings in this real-world program were consistent with
previously published data from clinical studies. All
treatment-emergent adverse events (TEAEs) were assessed as
unrelated to tab-cel by the treating physician and were consistent
with patients’ underlying diseases. Detailed results on baseline
demographics and disease characteristics, and additional safety
data including tab-cel exposure details, will be shared at the
conference.
Pierre Fabre leads all commercialization, distribution, medical
and regulatory activities for EbvalloTM in Europe, Middle East,
Africa and other selected markets.
Poster Presentation
Details:
Title: Effectiveness and safety outcomes in patients with
EBV+ PTLD treated with allogeneic EBV-specific T-cell immunotherapy
(tabelecleucel) under an expanded access program (EAP) in Europe
Presenting Author: Ralf Trappe, M.D., DIAKO Evangelisches
Diakonie-Krankenhaus Bremen, Bremen, Germany Date &
Time: June 5, 2023, at 8-11 a.m. CDT / 6-9 a.m. PDT Abstract
Number: 7521 Poster Number: 72 Session:
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Location: McCormick Place Convention Center Chicago, Hall
A
About Atara Biotherapeutics, Inc. Atara is harnessing the
natural power of the immune system to develop off-the-shelf cell
therapies for difficult-to-treat cancers and autoimmune conditions,
including multiple sclerosis, that can be rapidly delivered to
patients within days. With cutting-edge science and differentiated
approach, Atara is the first company in the world to receive
regulatory approval of an allogeneic T-cell immunotherapy. Our
advanced and versatile Epstein-Barr virus (EBV) T-cell platform
does not require T-cell receptor or HLA gene editing and forms the
basis of a diverse portfolio of investigational therapies that
target EBV, the root cause of certain diseases, in addition to
next-generation CAR-Ts designed for best-in-class opportunities
across a broad range of non-EBV-associated liquid and solid tumors.
Atara is headquartered in Southern California. For more
information, visit atarabio.com and follow @Atarabio on Twitter and
LinkedIn.
Forward-Looking Statements This press release contains or
may imply "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. For example, forward-looking
statements include statements regarding tab-cel: the development,
timing and progress of tab-cel, including data from tab-cel EAP and
clinical trials, the potential characteristics and benefits of
tab-cel, Atara’s ability to successfully advance the development of
tab-cel and its programs, and Pierre Fabre’s activities relating to
the commercialization of EBVALLO™ in Europe and the timing thereof.
Because such statements deal with future events and are based on
Atara’s current expectations, they are subject to various risks and
uncertainties and actual results, performance or achievements of
Atara could differ materially from those described in or implied by
the statements in this press release. These forward-looking
statements are subject to risks and uncertainties, including,
without limitation, risks and uncertainties associated with the
costly and time-consuming pharmaceutical product development
process and the uncertainty of clinical success; the COVID-19
pandemic and the war in Ukraine, which may significantly impact (i)
our business, research, clinical development plans and operations,
including our operations in Southern California and Denver and at
our clinical trial sites, as well as the business or operations of
our third-party manufacturer, contract research organizations or
other third parties with whom we conduct business, (ii) our ability
to access capital, and (iii) the value of our common stock; the
sufficiency of Atara’s cash resources and need for additional
capital; and other risks and uncertainties affecting Atara’s and
its development programs, including those discussed in Atara’s
filings with the Securities and Exchange Commission , including in
the “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” sections of the
Company’s most recently filed periodic reports on Form 10-K and
Form 10-Q and subsequent filings and in the documents incorporated
by reference therein. Except as otherwise required by law, Atara
disclaims any intention or obligation to update or revise any
forward-looking statements, which speak only as of the date hereof,
whether as a result of new information, future events or
circumstances or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20230602005342/en/
Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com Media Alex Chapman 805-456-4772
achapman@atarabio.com
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