Combined Analysis That Includes First Reported
Data from Multicohort Phase 2 EBVision Trial Consistent with
Previous Single-Center Experience
Pooled Analysis Shows 77.8% Objective Response
Rate (ORR) in 18 EBV+ CNS PTLD Patients, Including First Line PTLD
Setting and Promising Long-Term Survival
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
positive new data for tabelecleucel (tab-cel® or EBVALLO™) in
patients with relapsed or refractory (r/r) or treatment-naïve
Epstein-Barr virus-positive post-transplant lymphoproliferative
disease involving the central nervous system (CNS) (EBV+ CNS PTLD)
following solid organ transplant (SOT) or hematopoietic cell
transplant (HCT). These results will be presented as an oral
session at the European Society for Medical Oncology
Immuno-Oncology (ESMO I‑O) Annual Congress taking place December
6-8, 2023, in Geneva, Switzerland.
The clinical experience from this combined analysis of four
single-arm, open-label studies, including the multicohort Phase 2
EBVision trial (NCT04554914, n=4) expands on previous data from two
single-center, Phase 2 studies (NCT00002663, n=10; NCT01498484,
n=2), and multicenter, expanded-access protocol (NCT02822495,
n=2).
“EBV+ CNS PTLD is a rare but extremely serious disease, and
patients often face a poor prognosis that underscores the urgent
medical need,” said AJ Joshi, M.D., Executive Vice President, Chief
Medical Officer at Atara. “We’re pleased to share new multicenter
data, including the first results from our ongoing multicohort
EBVision trial and first clinical trial report of treatment with
tab-cel in the first line setting. Tab-cel shows a strong objective
response rate in these high-risk patients with a favorable safety
profile for patients with EBV-driven diseases.”
In this pooled analysis, a total of 18 patients, including one
previously untreated patient, with EBV+ CNS PTLD received cycles of
three weekly infusions of tab-cel at ~2x106 cells/kg. Key endpoints
were objective response rate (ORR), overall survival (OS), and
safety parameters. Patients received a median (range) of 1 (0 to 5)
lines of prior therapy.
An ORR of 77.8% (14/18) was observed in all patients (95% CI:
52.4, 93.6), with a best overall response of Complete Response (CR;
38.9%; n=7) or Partial Response (PR; 38.9%; n=7). The median time
to response (TTR) in all patients was 1.8 months (range:
0.7–6.4).
The estimated one-year overall survival (OS) rate was 70.6% (95%
CI: 43.0, 86.6) for all patients. The one-year OS rate for
responders was 85.7% versus 0% for non-responders.
Tab-cel was well-tolerated. No reports of serious
treatment-emergent adverse events, including neurotoxicity, organ
rejection, graft versus host disease, or tumor flare reaction of
any grade, were identified related to tab-cel.
Detailed results on baseline demographics, disease
characteristics, best overall response, OS, and additional safety
data including tab-cel exposure details, will be presented on
December 7 in the Proffered Paper Session 2.
Oral Presentation Details:
Title: Clinical Experience of Tabelecleucel in Epstein-Barr
Virus-Positive Post-transplant Lymphoproliferative Disease (EBV+
PTLD) Involving the Central Nervous System Presenting
Author: John Patton, M.D., Ph.D., James Comprehensive Cancer
Center, The Ohio State University, Columbus, OH Date &
Time: December 7, 2023, at 2:15 - 3:45 p.m. CET / 5:15 - 6:45
a.m. PST Presentation Number: 49O Session: Proffered
Paper Session 2 Location: Palexpo Congress Centre, Room
B
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 AlloCAR-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 X (formerly known as 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
the development, timing and progress of tabelecleucel (tab-cel® or
EBVALLO™), the potential characteristics and benefits of
tabelecleucel (tab-cel® or EBVALLO™), including data and analyses
from the EBVision study and the timing of when such data will be
received and communicated. 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231129702180/en/
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
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