First Phase 3 Results Published for an
Allogeneic T-Cell Therapy
Significant 51.2% Objective Response Rate and
23.0 Month Median Duration of Response in Relapsed or Refractory
EBV+ PTLD Patients
U.S. BLA on Track for Submission in Q2 2024
Based on Strong Clinical File
CASTRES, France and THOUSAND OAKS, Calif.,
Feb. 1,
2024 /PRNewswire/ -- 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, and Pierre Fabre Laboratories, a
global player in oncology and responsible for worldwide
commercialization of tabelecleucel (tab-cel® or
EBVALLO®), today announced that data from the pivotal
Phase 3 ALLELE study of tab-cel, approved in the European Union in
adults and children two years of age and older 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), were
published for the first time online in The Lancet
Oncology.
The data were published in an article titled, "Tabelecleucel for
allogeneic haematopoietic stem-cell or solid organ transplant
recipients with Epstein–Barr virus-positive post-transplant
lymphoproliferative disease after failure of rituximab or rituximab
and chemotherapy (ALLELE): a phase 3, multicentre, open-label
trial," and can be accessed at the following link:
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00649-6/fulltext
"The results of the ALLELE study highlight the clinical value of
tab-cel, which is now EMA and MHRA approved, and is being made
available to patients in Europe
through our partner Pierre Fabre Laboratories as a
first-of-its-kind treatment for those with a devastating disease
that previously had limited treatment options," said Pascal Touchon, President and Chief Executive
Officer of Atara. "As we prepare for our tab-cel BLA submission in
the second quarter 2024, we look forward to interacting with the
FDA to progress towards approval based on our robust clinical
data."
As reported in The Lancet Oncology publication, the ALLELE study
met its primary endpoint, with 22 of 43 EBV+ PTLD patients
achieving an objective response (51.2% objective response rate, or
ORR). Those that responded to tab-cel had longer survival, with an
estimated one-year overall survival of 84.4% (95% CI: 58.9, 94.7)
for responders versus 34.8% (95% CI: 14.6, 56.1) for
non-responders. The median duration of response was 23.0 months and
the median overall survival was 18.4 months. Tab-cel was well
tolerated with no reports of tumor flare reaction, cytokine release
syndrome or immune effector cell-associated neurotoxicity syndrome,
and no events of graft-versus-host disease or SOT rejection as
related to tab-cel. These data were previously presented at
the 2022 American Society of Hematology (ASH) Annual Meeting.
These pivotal trial data are supported by a more recent updated
data analysis from the ALLELE study that continued to demonstrate a
statistically significant 49% ORR (p<0.0001), consistent
durability of response, estimated OS, and favorable safety profile
in the intended population for the proposed U.S. label. ln
addition, real-world results from the multicenter Expanded Access
Program study in Europe
demonstrated an ORR of 66.7% in 24 EBV+ PTLD patients and were
previously presented at the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting.
"Patients with relapsed or refractory EBV+ PTLD have limited
treatment options and poor overall survival measured in only weeks
to months," said Susan Prockop, MD,
lead investigator, Boston Children's Hospital-Dana Farber Cancer
Institute. "These clinically meaningful data reinforce the
life-saving potential of tabelecleucel for these patients, for whom
there are no approved therapies in the U.S. and helps address an
urgent unmet medical need."
Tab-cel was granted marketing authorization under the brand name
EBVALLO® in December 2022
by the European Commission (EC) as a monotherapy for the treatment
of adult and pediatric patients two years of age and older with r/r
EBV+ PTLD who have received at least one prior therapy. For solid
organ transplant patients, prior therapy includes chemotherapy
unless chemotherapy is inappropriate. In the United States, Atara plans to submit a
biologics license application (BLA) to the U.S. Food and Drug
Administration for tab-cel for the treatment of EBV+ PTLD in the
second quarter of 2024. Additionally, in December 2023, Atara reported the first
results from the ongoing Phase 2 EBVision trial, which has the
potential to further extend the clinical experience and potential
of tab-cel into broader indications.
In December 2023, Atara announced
the closing of the expanded global partnership with Pierre Fabre
Laboratories for the U.S. and remaining global commercial markets
for tabelecleucel, building on an initial partnership covering
Europe, Middle East, Africa, and other select emerging markets.
"Current results from the first global, multicenter, open-label
Phase 3 study of the new allogeneic T-cell therapy, tabelecleucel,
show significant clinical benefit and a favorable safety profile in
a severely affected population. These results bring a lot of hope
for patients, and confirm the innovative nature of this treatment,
also recognized through the Prix Galien prize that we received in
France. With the recent EU
marketing authorization, EBVALLO® is the first
EBV-specific allogeneic T-cell therapy available for patients with
r/r EBV+ PTLD after HCT or SOT and their families. All this
resonates perfectly with our purpose 'every time we care for a
single person, we make the whole world better,'" said Núria
Perez-Cullell, Director of Medical Affairs, Patients &
Consumers at Pierre Fabre Laboratories.
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 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
AlloCAR-Ts designed for best-in-class opportunities across a broad
range of hematological malignancies and B-cell driven autoimmune
diseases. Atara is headquartered in Southern California. For more information,
visit atarabio.com and
follow @Atarabio on X and LinkedIn.
About Pierre Fabre Laboratories
Pierre Fabre Laboratories is a leading French medical and beauty
care company with 4 decades of experience in innovation,
development, manufacturing, and commercialization in oncology. The
company dedicated about 80% of its R&D spendings to oncology in
2022 with a focus on targeted therapies. Its current commercial
portfolio in oncology covers colorectal, breast and lung cancers,
melanoma, hematology, and pre-cancerous skin conditions like
actinic keratosis.
In 2022, Pierre Fabre Laboratories posted 2.7 billion euros in revenues, 69% of which came
from international sales in 120 countries. Established in the
South-West of France since its
creation in 1962, the Group manufactures 90% of its products in
France and employs some 10 000
people worldwide. The company is 86%-owned by the Pierre Fabre
Foundation, a government-recognized public-interest foundation, and
by its own employees through an international employee stock
ownership plan. Pierre Fabre Laboratories' sustainability policy
has been assessed by the independent AFNOR Certification body at
the "Exemplary" level of its CSR label (ISO 26 000 standard for
sustainable development).
Further information about Pierre Fabre Laboratories can be found
at www.pierre-fabre.com, @PierreFabre.
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
the development, data, timing and progress, as applicable, of: (1)
the tab-cel program, including a potential BLA submission for
tab-cel in the United States; (2)
the potential characteristics and benefits of tab-cel, including
data and analyses from the ALLELE study and timing of when such
data will be received and communicated; and (3) the amended and
restated commercialization agreement with Pierre Fabre. 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 ongoing COVID-19 pandemic and the wars in
Ukraine and the Middle East, 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.
Atara Investor and Media Relations:
Alex Chapman
Vice President, Corporate Communications & Investor
Relations
achapman@atarabio.com
Jason Awe, Ph.D.
Senior Director, Corporate Communications & Investor
Relations
jawe@atarabio.com
Pierre Fabre Laboratories Media Contact:
Laurence Marchal
laurence.marchal@pierre-fabre.com
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