The results will be featured in a poster presentation at the 2023
Atara supported 27 EAP requests in
An objective response rate (ORR) of 66.7% (16/24) was observed for both SOT and HCT groups (95% CI: 44.7, 84.4), 56.3% (9/16) for patients following SOT (95% CI: 29.9, 80.2) and 87.5% (7/8) for HCT patients (95% CI: 47.3, 99.7) with a best overall response of Complete Response (CR; 33.3%; n=4, SOT, n=4, HCT) or Partial Response (PR; 33.3%; n=5, SOT, n=3, HCT).
'These real-world results affirm the favorable risk-benefit profile seen in the pivotal Phase 3 ALLELE study which supported tab-cel as the first-ever allogeneic T-cell immunotherapy approved,' said AJ Joshi, MD, Chief Medical Officer at Atara. 'Tab-cel was well tolerated and delivered a one-year survival rate of nearly 91% in responders, reinforcing its potential to address an urgent unmet medical need for EBV+ PTLD patients.'
The median time to response (TTR) in all patients was 1.0 month (range: 0.8-2.2). Of the subgroup of patients with EBV+ PCNS PTLD, three out of four (75%; 95% CI: 19.4, 99.4) treated patients achieved a response with one CR and two PRs.
One-year survival rates were 73.7% (95% CI: 47.3, 88.3) across both groups, 66.5% for SOT patients (95% CI: 32.7, 86.2) and 87.5% for HCT patients (95% CI: 38.7, 98.1). EBV+ PTLD patients responding to tab-cel had longer one-year survival compared to the non-responders, with a one-year survival rate of 90.9% (95% CI: 50.8, 98.7) versus 34.3% (95% CI: 4.8, 68.5) for non-responders.
'These data provide important insights on the effectiveness of EBVALLO in the real-world treatment setting,' said Dr.
Safety findings in this real-world program were consistent with previously published data from clinical studies. All treatment-emergent adverse events (TEAEs) were assessed as unrelated to tab-cel by the treating physician and were consistent with patients' underlying diseases. Detailed results on baseline demographics and disease characteristics, and additional safety data including tab-cel exposure details, will be shared at the conference.
Poster Presentation Details
Title: Effectiveness and safety outcomes in patients with EBV+ PTLD treated with allogeneic EBV-specific T-cell immunotherapy (tabelecleucel) under an expanded access program (EAP) in
Presenting Author:
Date & Time:
Abstract Number: 7521
Poster Number: 72
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia
Location: McCormick Place Convention Center Chicago, Hall A
About
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 CAR-Ts designed for best-in-class opportunities across a broad range of non-EBV-associated liquid and solid tumors. Atara is headquartered in
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 EAP and clinical trials, the potential characteristics and benefits of tab-cel, Atara's ability to successfully advance the development of tab-cel and its programs, and
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Email: ehyllengren@atarabio.com
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