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
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. 22 of 43 EBV+ PTLD patients achieved 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 interim data were previously presented at the 2022
American Society of Hematology (ASH) Annual Meeting.
These pivotal trial data are supported by a recent updated
analysis from the October 2023 data cut of the ongoing 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240131800324/en/
Atara Investor and Media Relations: Alex Chapman Vice
President, Corporate Communications & Investor Relations (805)
456-4772 achapman@atarabio.com
Jason Awe, Ph.D. Senior Director, Corporate Communications &
Investor Relations (805) 217-2287 jawe@atarabio.com
Pierre Fabre Laboratories Media Contact: Laurence Marchal
+33 7 88 88 54 47 laurence.marchal@pierre-fabre.com
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