Phase 3 ALLELE Study Shows 51.2% Objective
Response Rate (ORR) in 43 EBV+ PTLD Patients
Median Duration of Response (DOR) of 23.0
Months
Median Overall Survival of 18.4 Months with
Patients Who Responded Having Longer Survival Than
Non-Responders
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
updated interim analysis and safety results from its Phase 3
multicenter ALLELE study investigating tabelecleucel (tab-cel®) for
the treatment of relapsed/refractory (r/r) Epstein-Barr virus
positive post-transplant lymphoproliferative disease (EBV+ PTLD)
following solid organ transplant (SOT) or hematopoietic cell
transplant (HCT).
The Phase 3 ALLELE study findings, along with updated efficacy
and safety data from two single-center, open-label studies as well
as a multicenter expanded access program investigating tab-cel
including patients with Epstein-Barr virus positive leiomyosarcomas
(EBV+ LMS), were featured among four poster presentations at the
64th American Society of Hematology (ASH) Annual Meeting taking
place December 10-13, 2022, in New Orleans.
“The updated efficacy and safety results of the Phase 3 ALLELE
study including additional patients and longer follow-up are
consistent with the transformative potential of tab-cel in EBV+
PTLD patients with no approved treatment options available,” said
Jakob Dupont, MD, Head of Global Research & Development at
Atara. “Similar to EBV+ PTLD, patients with EBV+ LMS face a poor
prognosis with limited treatment options, underscoring the
significant need for effective and safe new therapeutic options. We
report exciting new data that suggest tab-cel may provide a
clinical benefit in these hard-to-treat patients with LMS and,
together with other EBV-driven diseases like PTLD, represent the
potential of tab-cel to transform the lives of thousands of
patients across multiple indications and geographies.”
In the ongoing Phase 3 ALLELE study, 43 patients — 14 HCT
recipients and 29 SOT recipients — were treated with tab-cel and
were included in the analysis. Patients received a median of 2
cycles (range: 1-6) of tab-cel. The median age of evaluable
patients for both SOT and HCT was 48.5 years (3.2–81.5) who had
received a median of 1 (range: 1-5) prior systemic treatments.
Responses per clinical and radiographic assessment were measured by
independent oncologic response adjudication (IORA) assessment.
Results as of November 2021 data cutoff showed:
- An objective response rate (ORR) of 51.2% (22/43) was observed
for both HCT and SOT groups (95% CI: 35.5, 66.7), 51.7% (15/29) for
patients following SOT (95% CI: 32.5, 70.6) and 50.0% (7/14) for
HCT patients (95% CI: 23.0, 77.0) with a best overall response of
Complete Response (CR; 27.9%; n=12; n=6, SOT, n=6, HCT) or Partial
Response (PR; 23.3%; n=10; n=9, SOT, n=1, HCT).
- The median time to response (TTR) in all patients was 1.0 month
(range: 0.7-4.7) and median duration of response (DOR) in 22
responders was 23.0 months (95% CI: 6.8, not estimable [NE]), with
12/22 responders having a DOR >6 months.
- Median overall survival (OS) of 18.4 months (95% CI: 6.9, NE)
in all patients, 16.4 months in SOT (95% CI: 5.0, NE) and not yet
reached in HCT (95% CI: 5.7, NE).
- One-year survival rates were 61.1% (95% CI: 43.7, 74.5), 56.2%
in SOT (95% CI: 34.6, 73.2) and 70.1% in HCT (95% CI: 38.5,
87.6).
- Patients responding to tab-cel had longer one-year survival
compared to the non-responders, with a one-year survival rate of
84.4% (95% CI: 58.9, 94.7) versus 34.8% (95% CI: 14.6, 56.1) for
non-responders.
In addition, Atara presented updated efficacy and safety data
investigating the potential of tab-cel in patients with EBV+ LMS
who have received at least one therapy. EBV+ LMS is a rare,
aggressive, and potentially fatal solid tumor that responds poorly
to radiation and chemotherapy. Among 18 patient-treatments, median
age was 8.9 years (range: 3–35) and 44.4% of patients were
male.
Results showed:
- A clinical benefit rate (CR, PR, and stable disease) of 77.8%
(14/18) (95% CI: 56.6, 96.2), and ORR of 22.2% (95% CI: 6.4, 47.6;
PR in all cases) was observed. Median follow-up for all patients
was 18.9 months (95% CI: 1.5, 109.3).
- The estimated median OS was 77.4 months (95% CI:18.0, NE) and
the median progression-free survival (PFS) was 12.5 months (95% CI:
5.5, NE).
- Median DOR was 6.2 months (95% CI: 4.8, NE) with a one-year DOR
rate of 37.5% (95% CI: 1.1, 80.8). The one-year survival rate was
86.7% (95% CI: 56.4, 96.5) and the estimated two-year survival rate
was 78.0% (95% CI: 45.5, 92.5).
In both the ALLELE and LMS studies, tab-cel was well tolerated
and the safety profile consistent with previous data. There was no
evidence of tumor flare reaction, infusion reactions, cytokine
release syndrome, transmission of infectious diseases, and no
events of graft versus host disease (GvHD) or organ rejection
related to tab-cel.
In separate posters, Atara also presented the methodology of
using T-cell receptor β (TCRβ) sequencing to identify allogeneic
cell product clones post-infusion and data confirming the absence
of clinical manifestation of immunogenicity following tab-cel
administration in patients enrolled in the ALLELE study.
Poster Presentation
Details:
Title: New and Updated Results from a Multicenter,
Open-Label, Global Phase 3 Study of Tabelecleucel (Tab-cel) for
Epstein–Barr Virus-Positive Post-Transplant Lymphoproliferative
Disease (EBV+ PTLD) Following Allogeneic Hematopoietic Cell (HCT)
or Solid Organ Transplant (SOT) after Failure of Rituximab or
Rituximab and Chemotherapy (ALLELE)
- Presenting Author: Kris Michael Mahadeo, MD, MPH, MD
Anderson Cancer Center, Houston, TX
- Date & Time: Monday, December 12, 2022, 6-8 p.m. CST
/ 5-7 p.m. PST
- Abstract Number: 4658
- Poster Session: 705. Cellular Immunotherapies: Late
Phase and Commercially Available Therapies: Poster III
- Location: Ernest N. Morial Convention Center, Hall
D
Title: Updated Efficacy and Safety of Tabelecleucel in
Patients with Epstein-Barr Virus-Positive (EBV+) Leiomyosarcomas
(LMS)
- Presenting Author: Lauren S. Jiménez-Kurlander, MD,
Boston Children's Hospital/Dana Farber Cancer Institute, Boston,
MA
- Date & Time: Sunday, December 11, 2022, 6-8 p.m. CST
/ 5-7 p.m. PST
- Abstract Number: 3349
- Poster Session: 705. Cellular Immunotherapies: Late
Phase and Commercially Available Therapies: Poster II
- Location: Ernest N. Morial Convention Center, Hall
D
Title: Utilizing TCRseq to Detect Tabelecleucel, an
Allogeneic Epstein-Barr Virus (EBV)-Specific T-Cell Therapy,
Post-Infusion
- Presenting Author: Fiona Ruiz, PhD, Atara
Biotherapeutics, Thousand Oaks, CA
- Date & Time: Saturday, December 10, 2022, 5:30-7:30
p.m. CST / 4:30-6:30 p.m. PST
- Abstract Number: 2169
- Poster Session: 803. Emerging Tools, Techniques and
Artificial Intelligence in Hematology: Poster I
- Location: Ernest N. Morial Convention Center, Hall
D
Title: Exploring the Impact of Humoral Immunogenicity
with Tabelecleucel for the Treatment of EBV+ PTLD Following HCT and
SOT
- Presenting Author: Tassja J. Spindler, Atara
Biotherapeutics, Thousand Oaks, CA
- Date & Time: Sunday, December 11, 2022, 6-8 p.m. CST
/ 5-7 p.m. PST
- Abstract Number: 3351
- Poster Session: 705. Cellular Immunotherapies: Late
Phase and Commercially Available Therapies: Poster II
- Location: Ernest N. Morial Convention Center, Hall
D
About Tabelecleucel
Tabelecleucel (tab‐cel) is an allogeneic, EBV-specific T-cell
immunotherapy which targets and eliminates EBV-infected cells in an
HLA-restricted manner. Tab-cel has been granted Breakthrough
Therapy Designation for the treatment of rituximab-refractory
EBV-associated lymphoproliferative disease (LPD) by the U.S. Food
and Drug Administration (FDA) and has orphan drug designation in
the U.S. Tabelecleucel received PRIME designation by the European
Medicines Agency (EMA) for the treatment of patients with
EBV-associated PTLD in the allogeneic hematopoietic stem cell
transplant (HCT) setting who have failed on rituximab and has
orphan drug designation in the 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 receiving a CHMP positive opinion
for a marketing authorization in Europe, 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 Southern 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
tab-cel®: the development, timing and progress of tab-cel®,
including data from tab-cel® clinical trials, the potential
characteristics and benefits of tab-cel®, and Atara’s ability to
successfully advance the development of tab-cel® and its programs .
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, 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/20221209005612/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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