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 long-term clinical results from a
multicenter Expanded Access Protocol (EAP) study of tab-cel®
(tabelecleucel) for patients with Epstein-Barr virus-associated
post-transplant lymphoproliferative disease (EBV+ PTLD) at the 61st
American Society of Hematology (ASH) Annual Meeting &
Exposition in Orlando, Fla.
Results from this analysis demonstrate a high overall response
rate (ORR), short time to response and favorable estimated
long-term overall survival (OS) rates for tab-cel® in patients with
EBV+ PTLD following hematopoietic cell transplant (HCT) or solid
organ transplant (SOT) who have failed rituximab-based therapy.
Tab-cel® was generally well-tolerated in all patients with EBV+
PTLD and other EBV-associated diseases.
“Patients undergoing allogeneic hematopoietic cell or solid
organ transplants are at risk for developing EBV+ PTLD,” said Sarah
Nikiforow, M.D., Ph.D., Assistant Professor of Medicine,
Dana-Farber Cancer Institute. “Unfortunately, many patients who
develop this often-aggressive lymphoma do not respond adequately to
rituximab with or without chemotherapy. Data presented today
demonstrate tab-cel® may provide an effective treatment option with
a compelling benefit-risk profile for patients with EBV+ PTLD
following HCT or SOT.”
Twenty-six EBV+ PTLD patients who failed prior rituximab
treatment regimens were enrolled in EAP-201 as of June 2018, after
which the study was amended (EAP-901, NCT02822495) to focus on
expanded access for patients with EBV+ PTLD and other EBV+ diseases
who are not eligible for Atara’s ongoing tab‑cel® Phase 3 study
(NCT03394365). The findings presented at the meeting are as of
September 24, 2019.
In the EBV+ PTLD HCT and SOT cohorts, 92 and 63 percent of
patients were intermediate/high risk according to the PTLD
prognostic index1, respectively.
SafetySafety analyses were presented for all
patients treated with tab-cel® (n=61; n=26 EBV+ PTLD and n=35
patients with other EBV-associated diseases). Consistent with prior
studies, tab-cel® was generally well-tolerated in all patients, and
no tab-cel® related adverse events leading to discontinuation
occurred.
The most common treatment-emergent serious adverse events
(TESAEs) reported in ≥ 5 percent of all patients were disease
progression (16 percent), pyrexia (8 percent) and pneumonia (7
percent).
Three graft versus host disease (GvHD) adverse events were
reported, all in patients with prior allogeneic HCT. No other
adverse events of special interest including cytokine release
syndrome were reported.
EfficacyMedian time to response of one month
was seen in both EBV+ PTLD patient cohorts. In responders, two-year
estimated overall survival rate was 86 percent for HCT (n=7) and
100 percent for SOT (n=10) with no patient deaths attributable to
PTLD progression.
Similar outcomes were observed in the EAP-201 subgroup of EBV+
PTLD patients (n=22) with adequate ECOG performance status, no CNS
disease and no PLTD-related ventilatory support who would have
likely met the eligibility criteria for Atara’s ongoing tab-cel®
Phase 3 studies. Overall response rate was 55 and 82 percent, with
a two-year estimated overall survival of 79 and 81 percent, in the
HCT (n=11) and SOT (n=11) cohorts, respectively.
“We have previously shown that EBV+ PTLD patients treated with
tab-cel® resulted in high overall response rates and favorable
long-term survival,” said AJ Joshi, MD, Senior Vice President and
Chief Medical Officer of Atara Biotherapeutics. “The findings
reported today are consistent with our previous observations, and
we look forward to further clinical investigation with tab-cel® for
the treatment of EBV+ PTLD and other ultra-rare EBV-associated
diseases.”
Efficacy for EBV+ PTLD HCT Cohort
HCT cohort |
All HCT (N=14) |
Potential Ph3 subset2 (N=11) |
Responders (N=7) |
ORR (investigator-assessed), n (%) |
7
(50) |
6
(55) |
- |
1-year
OS, % (95% CI) |
60 (29,
81) |
79 (38,
94) |
86 (33,
98) |
2-year OS, % (95% CI) |
60 (29, 81) |
79 (38, 94) |
86 (33, 98) |
Efficacy for EBV+ PTLD SOT Cohort
SOT cohort |
All SOT (N=12) |
Potential Ph3 subset2 (N=11) |
Responders (N=10) |
ORR (investigator-assessed), n (%) |
10
(83) |
9
(82) |
- |
1-year
OS, % (95% CI) |
83 (46,
95) |
81 (42,
95) |
100 |
2-year OS, % (95% CI) |
83 (46, 95) |
81 (42, 95) |
100 |
Abstract/Presentation Details:
Abstract 4071: Long-Term Outcomes of Subjects
with Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative
Disorder (EBV+PTLD) Following Solid Organ (SOT) or Allogeneic
Hematopoietic Cell Transplants (HCT) Treated with Tabelecleucel on
an Expanded Access Program Poster Presentation Date and
Time: Monday, December 9, 6:00 - 8:00 p.m.
ESTSession Title: 626. Aggressive Lymphoma
(Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin
Lymphoma) – Results from Prospective Clinical Trials: Poster
IIILocation: Orange County Convention Center, Hall
BAuthors: Susan Prockop, M.D.1, Ran Reshef,
M.D.2, Donald E. Tsai, M.D., Ph.D.3, Nancy Bunin, M.D.4, Rolla
Abu-Arja, M.D.5, Kris Michael Mahadeo, M.D.6, Wen-Kai Weng, M.D.,
Ph.D.7, Koen Van Besien, M.D., Ph.D.8, David Loeb, M.D., Ph.D.9,
Sunita Dwivedy Nasta, M.D.10, Eneida R. Nemecek, M.D., M.B.A.,
M.S.11, Minoti Hiremath, MBBS, Ph.D.12, Susan Yue, M.D.13, Yan Sun,
Ph.D.13, Willis H Navarro, M.D.12 and Sarah Nikiforow, M.D.,
Ph.D.14 Affiliations: 1Memorial Sloan Kettering
Cancer Center, New York, NY; 2Columbia University Irving Medical
Center, New York, NY; 3Loxo Oncology, Stamford, CT; 4Children's
Hospital of Philadelphia, Philadelphia, PA; 5Nationwide Children's
Hospital, Columbus, OH; 6MD Anderson Cancer Center, Houston, TX;
7Division of Blood and Marrow Transplantation, Department of
Medicine, Stanford Univ. School of Med., Stanford, CA; 8Division of
Hematology and Oncology, Weill Cornell Medical College, New York,
NY; 9Montefiore, Bronx, NY; 10University of Pennsylvania,
Philadelphia, PA; 11Pediatric Hematology/Oncology & Bone Marrow
Transplantation, OHSU Knight Cancer Institute Doernbecher
Children's Hospital, Portland, OR; 12Atara Biotherapeutics, South
San Francisco, CA; 13Atara Biotherapeutics, Thousand Oaks, CA;
14Dana-Farber Cancer Institute, Boston, MA
References 1Choquet S et al. Ann Hematol 2007;
86:599–6072Based on adequate ECOG performance status, no CNS
disease, and no PTLD-related ventilatory support
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
technology platform leverages research collaborations with leading
academic institutions with the Company’s scientific, clinical,
regulatory and manufacturing expertise. Atara’s pipeline includes
tab-cel® (tabelecleucel), which is in Phase 3 development for
patients with Epstein-Barr virus-associated post-transplant
lymphoproliferative disease (EBV+ PTLD) as well as in earlier stage
development for other EBV-associated hematologic malignancies and
solid tumors, including nasopharyngeal carcinoma (NPC); T-cell
immunotherapies targeting EBV antigens believed to be important for
the potential treatment of multiple sclerosis; and next-generation
chimeric antigen receptor T-cell (CAR T) immunotherapies. The
company was founded in 2012 and is co-located in South San
Francisco and Southern California. Our Southern California hub is
anchored by the state-of-the-art Atara T-cell Operations and
Manufacturing (ATOM) facility in Thousand Oaks, California. For
additional information about the company, please visit
atarabio.com.
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 effectiveness, impact and benefit-risk profile of
tab-cel®; and the results from Atara’s ongoing tab-cel® EAP
study. 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 CONTACT:
John Craighead, Ph.D. Vice President, Investor Relations &
Corporate Communications Atara Biotherapeutics 650-410-3012
jcraighead@atarabio.com
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