Atara Biotherapeutics Presents Positive Efficacy and Safety Results for Patients with Epstein-Barr Virus-Associated Leiomyosa...
December 15 2018 - 8:00AM
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading
off-the-shelf, allogeneic T-cell immunotherapy company developing
novel treatments for patients with cancer, autoimmune and viral
diseases, today presented results indicating that tab-cel®
(tabelecleucel) was generally well tolerated with responses for
patients with Epstein-Barr virus-associated leiomyosarcoma (EBV+
LMS). EBV+ LMS is a rare soft tissue sarcoma that occurs in
transplant and immunosuppressed patients and is typically an
aggressive radiation- and chemotherapy-resistant disease with poor
patient outcomes. The results were presented in an oral session at
the European Society for Medical Oncology Immuno-Oncology (ESMO
I‑O) Congress 2018 taking place in Geneva, Switzerland.
“The EBV+ LMS results presented at ESMO I-O are the second
example, along with nasopharyngeal carcinoma (NPC), of a
difficult-to-treat, EBV-associated solid tumor with encouraging
responses to tab‑cel®,” said Dietmar Berger, M.D., Ph.D.,
Global Head of Research and Development of Atara
Biotherapeutics. “Observations of responses based on standard-CT
and metabolic PET-CT imaging, in the context of prolonged survival,
further highlight the opportunity for tab‑cel® and off-the-shelf,
allogeneic T-cell immunotherapy in EBV-associated cancers beyond
our ongoing studies for patients with post‑transplant
lymphoproliferative disease (PTLD) and NPC.”
The oral presentation summarized the evaluation of tab-cel® in
an analysis of EBV+ LMS patients from three clinical studies, 2
single-center, open-label studies (NCT00002663, NCT01498484) and
the multi‑center expanded access protocol (EAP) study
(NCT02822495). Twelve patients with EBV+ LMS received one or more
doses of tab-cel®, of whom 10 were assessed for responses with two
patients not evaluable. Two of the 10 patients achieved a partial
response via CT-based RECIST 1.1 criteria and eight patients
achieved stable disease. In the two single-center studies with
longer follow-up, six of eight patients survived more than 27
months and the estimated median survival was 77.4 months. At the
time of this analysis, responses assessed by PET-CT imaging were
available from the multi-center EAP study where 3 of the 4 patients
achieved a metabolic response. Tab-cel® was generally well
tolerated and the safety appeared consistent with a favorable risk
profile and previous clinical studies.
About tab-cel® (tabelecleucel)Atara's most
advanced T-cell immunotherapy in development, tab-cel®, is a
potential treatment for patients with Epstein-Barr virus
(EBV)-associated post-transplant lymphoproliferative disorder (EBV+
PTLD) who have failed rituximab, as well as other EBV-associated
hematologic and solid tumors, including nasopharyngeal carcinoma
(NPC). In February 2015, the FDA granted tab-cel® Breakthrough
Therapy Designation for EBV+ PTLD following allogeneic
hematopoietic cell transplant (HCT), and in October 2016, tab-cel®
was accepted into the EMA Priority Medicines (PRIME) regulatory
pathway for the same indication, providing enhanced regulatory
support. In addition, tab-cel® has orphan status in the U.S. and
EU. Tab-cel® is in Phase 3 clinical development for the treatment
of EBV+ PTLD following an allogeneic hematopoietic cell transplant
(MATCH study) or solid organ transplant (ALLELE study), and Atara
recently initiated a Phase 1/2 study in NPC.
About Atara Biotherapeutics, Inc.Atara
Biotherapeutics, Inc. (@Atarabio) is a leading off-the-shelf,
allogeneic T-cell immunotherapy company developing novel treatments
for patients with cancer, autoimmune and viral diseases. Atara’s
most advanced T-cell immunotherapy, tab-cel® (tabelecleucel), is in
Phase 3 development for patients with Epstein-Barr virus-associated
post-transplant lymphoproliferative disorder (EBV+ PTLD), as well
as other EBV-associated hematologic and solid tumors, including
nasopharyngeal carcinoma (NPC). Atara is also developing T-cell
immunotherapies targeting EBV antigens believed to be important for
the potential treatment of multiple sclerosis (MS). Atara's
pipeline also includes next-generation chimeric antigen receptor
T-cell (CAR T) immunotherapies for patients with hematologic and
solid tumors, autoimmune and infectious diseases. The company was
founded in 2012 and is headquartered in South San Francisco,
California.
Forward-Looking StatementsThis 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 safety
of, and responses to, tab-cel®; the prospects of tab-cel® and
off-the-shelf, allogeneic T-cell immunotherapy in EBV-associated
cancers; and current clinical results. Because such statements deal
with future events and are based on Atara
Biotherapeutics' current expectations, they are subject to
various risks and uncertainties and actual results, performance or
achievements of Atara Biotherapeutics 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 those discussed in Atara
Biotherapeutics' filings with the Securities and Exchange
Commission (SEC), 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
Biotherapeutics 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.
INVESTOR & MEDIA CONTACTS:
Investors:John Craighead, Atara
Biotherapeutics650-410-3012jcraighead@atarabio.com
John Grimaldi, Burns McClellan212-213-0006
x362jgrimaldi@burnsmc.com
Media:Nancie Steinberg, Burns
McClellan212-213-0006 x318nsteinberg@burnsmc.com
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