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Atara reports positive Phase 2 results for tab-cel.

M2 PHARMA-June 15, 2018-Atara reports positive Phase 2 results for tab-cel

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Atara Biotherapeutics Inc (Nasdaq: ATRA) has recorded positive long-term outcomes in two Phase 2 studies of tab-cel (tabelecleucel), its off-the-shelf T-cell immunotherapy, the company revealed on Friday.

The single centre, open-label studies involved patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) following allogeneic hematopoietic cell transplant (HCT) or solid organ transplant (SOT) who failed first-line therapy.

Both trials demonstrated durable remissions and encouraging safety findings.

One- and three-year overall survival for tab-cel treated patients with EBV+ PTLD following HCT who failed rituximab was 68% and 55%, respectively. Median survival was not reached after 23.3 months of follow-up in this patient group. The expected median survival for patients with EBV+ PTLD following HCT who have failed rituximab first line therapy is 16 to 56 days.

In patients with EBV+ PTLD following SOT who failed rituximab, the one- and three-year overall survival after treatment with tab-cel was 64% and 43%, respectively. Median survival in this patient group was 21.3 months, which compares favourably to the expected 12- to 13-month median survival in patients with EBV+ PTLD following SOT who fail to achieve a complete response to first-line therapy with rituximab.

None of the EBV+ PTLD patients who had complete or partial responses after treatment with tab-cel died of EBV+ PTLD. Two-year survival for these responding patients was 83% and 86% following HCT and SOT, respectively.

The treatment was associated with durable overall response rates of 69% and 50% in patients with EBV+ PTLD following HCT and SOT, respectively, who have failed rituximab.

Results from the first Phase 3 study of tab-cel are anticipated in the first half of 2019, when Atara also expects to submit a conditional marketing authorisation application in the European Union.

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Publication:M2 Pharma
Article Type:Financial report
Date:Jun 15, 2018
Words:312
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