Positive New ALLELE Results Show 50% Objective
Response Rate (ORR) and Strong Safety Profile Reinforcing
Transformative Potential of Tab-cel®
One-year Survival Rate of 89.2% for Patients
Responding to Tab-cel Compared with 32.4% Among Non-Responders
Long-term Survival Benefit in Patients who
Responded to Tab-cel Demonstrated in Separate Pooled Data Analysis
from Phase 2 and Multicenter Expanded Access Protocol Studies
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 the
upcoming first release of efficacy and safety results from its
Phase 3 ALLELE study. The pivotal trial is investigating
tabelecleucel (tab-cel®) for the treatment of Epstein-Barr
virus-positive post-transplant lymphoproliferative disease (EBV+
PTLD) following solid organ transplant (SOT) or hematopoietic cell
transplant (HCT). Detailed findings, along with combined data from
investigator-sponsored Phase 2 and multicenter Expanded Access
Program (EAP) studies, will be featured among eight abstracts,
including two oral presentations, at the 63rd American Society of
Hematology (ASH) Annual Meeting taking place December 11-14, 2021,
in Atlanta.
“There is significant unmet need in patients with EBV+ PTLD,
with poor overall survival measured in weeks to a few months after
first-line treatment failure,” said Jakob Dupont, MD, Head of
Global Research & Development at Atara. “Tab-cel demonstrated a
clinically meaningful objective response rate and striking overall
survival in a patient population with no approved treatment
options, representing a first-in-kind allogeneic therapy with
transformative potential. At ASH, we will share data from our Phase
3 ALLELE study, which further supports tab-cel as a potentially
safe and effective treatment option for patients with EBV-driven
diseases.”
As reported in the full abstract available today on the ASH
website, top-line data with additional patients and extended follow
up confirm a strong ORR in line with prior Phase 2 and multicenter
EAP results and demonstrate durability of response with no new
safety signals.
In this ongoing Phase 3 study, 38 evaluable patients as of May
2021 — 24 EBV+ PTLD following SOT patients after failure of
rituximab ± chemotherapy and 14 EBV+ PTLD following HCT patients
after failure of rituximab monotherapy — were treated with tab-cel
and had the opportunity for a six-month follow-up after response.
An ORR, as measured by independent oncologic response adjudication
(IORA) assessment, of 50% (19/38, 95% CI: 33.4, 66.6) was observed,
with an ORR of 50.0% (12/24, 95% CI: 29.1, 70.9) in PTLD following
SOT and 50.0% (7/14, CI: 23.0, 77.0) in PTLD following HCT, with a
best overall response of Complete Response (CR; n=5, SOT; n=5, HCT)
or Partial Response (PR; n=7, SOT; n=2, HCT).
Overall, the median time to response (TTR) was 1.1 months
(0.7-4.7). Of 19 responders, 11 had a duration of response (DOR)
lasting more than six months and median DOR has not been reached
yet. Those who responded had a longer survival compared to the
non-responders, with a median OS not evaluable (NE) (95% CI: 16.4,
NE) and a 1-year survival rate of 89.2% (95% CI: 63.1, 97.2).
Safety findings were consistent with previously published data,
with no new signals or concerns reported. There were no reports of
tumor flare reaction, and no confirmed evidence of graft versus
host disease (GvHD), organ rejection, infusion reactions, or
cytokine release syndrome related to tab-cel.
Further detail on baseline demographics and disease
characteristics, and additional safety data including tab-cel
exposure details, will be presented on December 11 in the oral
presentation.
Atara will present additional data on tab-cel and PTLD through
several abstracts, including a second oral presentation on long
term OS from Phase 2 and multicenter EAP studies with tab-cel in
relapsed/refractory EBV+ PTLD showing median OS of 54.6 months in
all patients and OS at two years reaching over 86% in responders
whether patients experienced CR or PR. Treatment was well tolerated
with no confirmed evidence for graft versus host disease, cytokine
release syndrome, SOT rejection, or neurologic events attributable
to tab-cel.
In total, five abstracts will be presented at the 63rd ASH
Annual Meeting. An additional three accepted abstracts will be
published online in the November supplemental issue of Blood.
Oral Presentation Details:
Title: Multicenter, Open-Label, Phase 3 Study of Tabelecleucel
for Solid Organ or Allogeneic Hematopoietic Cell Transplant
Recipients with Epstein-Barr Virus-Driven Post Transplant
Lymphoproliferative Disease after Failure of Rituximab or Rituximab
and Chemotherapy (ALLELE)
- Presenting Author: Susan Prockop, MD, Boston Children's
Hospital/Dana Farber Cancer Institute, Boston, MA
- Date & Time: Saturday, December 11, 2021, at 4:00
p.m. EST/1:00 p.m. PST
- Abstract Number: 301
- Session: 626. Aggressive Lymphomas Prospective
Therapeutic Trials: Challenging Populations
- Location: Georgia World Congress Center, B401-B402
Title: Overall Survival by Best Overall Response with
Tabelecleucel in Patients with Epstein-Barr Virus-Driven
Post-Transplant Lymphoproliferative Disease Following Solid Organ
or Allogeneic Hematopoietic Cell Transplant
- Presenting Author: Susan Prockop, MD, Boston Children's
Hospital/Dana Farber Cancer Institute, Boston, MA
- Date & Time: Monday, December 13, 2021, at 7:15 p.m.
EST/4:15 p.m. PST
- Abstract Number: 887
- Session: 627. Aggressive Lymphomas: Clinical and
Epidemiological: Real World Evidence for CAR-T Management II
- Location: Georgia World Congress Center, C101
Auditorium
Poster Presentation Details:
Title: Clinical Outcomes of Patients with Epstein-Barr
Virus-Driven Post-Transplant Lymphoproliferative Disease Following
Hematopoietic Stem Cell Transplantation Who Fail Rituximab: A
Multinational, Retrospective Chart Review Study
- Presenting Author: Jaime Sanz, MD, University Hospital
La Fe in Valencia, Valencia, Spain
- Date & Time: Saturday, December 11, 2021, at
5:30-7:30 p.m. EST/2:30-4:30 p.m. PST
- Abstract Number: 1454
- Session: 627. Aggressive Lymphomas: Clinical and
Epidemiological: Poster I
- Location: Georgia World Congress Center, Hall B5
Title: Clinical Outcomes of Solid Organ Transplant
Patients with Epstein-Barr Virus-Driven (EBV+) Post-Transplant
Lymphoproliferative Disorder (PTLD) Who Fail Rituximab Plus
Chemotherapy: A Multinational, Retrospective Chart Review Study
- Presenting Author: Vikas Dharnidharka, MD, MPH,
Washington University School of Medicine & St. Louis Children’s
Hospital, St Louis, MO
- Date & Time: Sunday, December 12, 2021, at 6:00-8:00
p.m. EST/3:00-5:00 p.m. PST
- Abstract Number: 2528
- Session: 627. Aggressive Lymphomas: Clinical and
Epidemiological: Poster II
- Location: Georgia World Congress Center, Hall B5
Title: Comprehensive Activation Profiling of the
Tabelecleucel Library, an Off-the-Shelf, Allogeneic EBV-Specific
T-Cell Therapy
- Presenting Author: Joseph M Benoun, PhD, Atara
Biotherapeutics, Thousand Oaks, CA
- Date & Time: Sunday, December 12, 2021, at 6:00-8:00
p.m. EST/3:00-5:00 p.m. PST
- Abstract Number: 2809
- Session: 703. Cellular Immunotherapies: Basic and
Translational: Poster II
- Location: Georgia World Congress Center, Hall B5
About Tabelecleucel Tabelecleucel (tab-cel®) is an
off-the-shelf, allogeneic T-cell immunotherapy in development for
the treatment of Epstein-Barr virus-positive post-transplant
lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of
lymphoma (cancer) that may occur after a solid organ transplant
(SOT) or allogeneic hematopoietic cell transplant (HCT). There are
currently no approved treatments indicated to treat PTLD and if
left untreated, PTLD can have life-threatening consequences.
Tab-cel is currently being investigated in the Phase 3 ALLELE
study to assess efficacy and safety for the treatment of EBV+ PTLD
in SOT and HCT after failure of standard of care.
Tab-cel has been granted Breakthrough Therapy Designation for
EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug
Administration (FDA) and PRIME designation by the European
Medicines Agency (EMA) for the same indication. Tab-cel has orphan
drug designation in the U.S. and EU.
About Atara Biotherapeutics, Inc. Atara Biotherapeutics,
Inc. (@Atarabio) is a pioneer in T-cell immunotherapy leveraging
its novel allogeneic EBV T-cell platform to develop transformative
therapies for patients with serious diseases including solid
tumors, hematologic cancers and autoimmune disease. With our lead
program in Phase 3 clinical development, Atara is the most advanced
allogeneic T-cell immunotherapy company and intends to rapidly
deliver off-the-shelf treatments to patients with high unmet
medical need. Our platform leverages the unique biology of EBV T
cells and has the capability to treat a wide range of
EBV-associated diseases, or other serious diseases through
incorporation of engineered CARs (chimeric antigen receptors) or
TCRs (T-cell receptors). Atara is applying this one platform, which
does not require TCR or HLA gene editing, to create a robust
pipeline including: tab-cel® in Phase 3 development for
Epstein-Barr virus-driven post-transplant lymphoproliferative
disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell
immunotherapy targeting EBV antigens as a potential treatment for
multiple sclerosis; and multiple next-generation chimeric antigen
receptor T-cell (CAR-T) immunotherapies for both solid tumors and
hematologic malignancies. Improving patients’ lives is our mission
and we will never stop working to bring transformative therapies to
those in need. Atara is headquartered in South San Francisco and
our leading-edge research, development and manufacturing facility
is based in Thousand Oaks, California.
For additional information about the company, please visit
atarabio.com and follow us 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: the potential benefits,
safety and efficacy of tab-cel®; the timing and progress of
tab-cel®, including (i) data and analyses from ALLELE study, the
investigator-initiated Phase 2 study, and the EAP; (ii) tab-cel®
clinical trials, and (iii) Atara’s ability to successfully advance
the development of tab-cel®. 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, which may
significantly impact (i) our business, research, clinical
development plans and operations, including our operations in South
San Francisco and Southern California 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 (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 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/20211104005811/en/
INVESTORS & MEDIA: Investors Eric Hyllengren
805-395-9669 ehyllengren@atarabio.com
Media Alex Chapman 805-456-4772 achapman@atarabio.com
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