Atara Biotherapeutics Announces Completion of the ATA188 Phase 2 EMBOLD Study Interim Analysis in Patients with Progressive MS
July 12 2022 - 4:30PM
Business Wire
Independent Data and Safety Monitoring
Committee Recommends Continuing Study Without Sample Size
Adjustment
IDSMC Did Not Identify Any Safety Concerns
Phase 2 Study Target Enrollment Achieved; Final
Data and Communication Expected in October 2023
Conference Call and Webcast Today at 2:00 p.m.
PDT/5:00 p.m. EDT
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell
immunotherapy, leveraging its novel allogeneic EBV T-cell platform
to develop transformative therapies for patients with cancer and
autoimmune diseases, today announced completion of the planned
Interim Analysis (IA) of the ATA188 Phase 2 randomized,
placebo-controlled study (EMBOLD) in June 2022. The IA included
review by the Independent Data and Safety Monitoring Committee
(IDSMC) of the efficacy, safety, and biomarker data available at
the data cut off, based on which the IDSMC recommended the study
continue without sample size adjustment.
The IA’s primary focus was on expanded disability status scale
(EDSS) improvement at six months and overall safety, and also
included evaluation of EDSS beyond six months for patients with
longer treatment duration, as well as other available clinical data
and magnetization transfer ratio (MTR) biomarker data. The IA was
also designed to assess if a sample size increase was needed based
on a conditional power modeling approach. The IA was planned to
occur before enrolling patient 80 to enable an increased sample
size if needed.
The main assessment at the EMBOLD IA was EDSS improvement at six
months, which in the 24-patient open label Phase 1 study, appeared
to be predictive of confirmed EDSS improvement at 12 months (the
primary endpoint for the EMBOLD study). At the time of the EMBOLD
IA, there were EDSS data on 34 patients evaluable at six months and
15 patients at 12 months (across both placebo and active groups
with 1:1 randomization).
Based on the analysis of the EMBOLD data available at the time
of the IA, there was not a sufficient dataset to draw conclusions
about the predictive value of six months EDSS improvement for 12
months EDSS improvement. The IDSMC believes the six-month interim
endpoint may be an inaccurate measure of the potential of this
intervention in this condition. The IDSMC recommended continuing
the study without sample size adjustment until the final analysis
of the primary endpoint of confirmed EDSS improvement at 12
months.
“Following the EMBOLD IA, we are proceeding with the IDSMC’s
recommendation that the study continue to completion without sample
size adjustment,” said Jakob Dupont, M.D., Head of Global Research
& Development at Atara. ”After reviewing the clinical and
safety data available at the data cut-off, the IDSMC did not
highlight any safety concerns in the ongoing study. We are pleased
to have completed the target enrollment for the EMBOLD study and
look forward to sharing the topline results as planned at an
appropriate forum in October 2023.”
After completing the IA in June, the target enrollment of 80
patients was achieved. Total enrollment will be higher as patients
that were already in screening through the end of June will be
allowed to continue the enrollment process. Final read out of the
study primary endpoint of confirmed EDSS improvement at 12 months
is planned to occur in October 2023.
“We look forward to completing the EMBOLD study as we aspire to
demonstrate a potentially transformative profile for ATA188 in
patients with progressive MS who have high unmet need and limited
options,” said Pascal Touchon, President and Chief Executive
Officer of Atara.
Conference Call and Webcast Details
Atara will host a live conference call and webcast today,
Tuesday July 12, 2022, at 5:00 p.m. EDT to discuss the EMBOLD IA.
Analysts and investors can participate in the conference call by
dialing 877-407-8291 for domestic callers and 201-689-8345 for
international callers, using the conference ID 13731189. A live
audio webcast can be accessed by visiting the Investors & Media
– News & Events section of atarabio.com. An archived replay
will be available on the Company's website for 30 days following
the live webcast.
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 and
currently under review to support registration 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® (tabelecleucel) in Phase 3 development
for Epstein-Barr virus-driven post-transplant lymphoproliferative
disease (EBV+ PTLD); 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. 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 ATA188; and the
timing and progress of ATA188, including (i) regulatory
designations for ATA188 granted by FDA and the impact thereof; (ii)
the mechanistic link between EBV and multiple sclerosis and the
ability of ATA188 to specifically target such link; (iii) data from
ATA188 OLE study; (iv) ATA188 clinical trials, (v) the interim
analysis for the EMBOLD study; (vi) the possibility of EDSS
improvement at six months to be predictive of EDSS improvement at
12 months; and (vii) Atara’s ability to successfully advance the
development of ATA188. 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 current
events involving Russia and Ukraine, 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/20220712006116/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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