Long-term results from two Phase 2 clinical trials evaluating Atara Biotherapeutics' (ATRA +0.9%) off-the-shelf T-cell immunotherapy tabelecleucel (tab-cel) in patients with Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disorder (EBV+PTLD) showed sustained benefits. The data were presented at the EHA Congress in Stockholm.
The studies assessed tab-cell in EBV+PTLD patients following hematopoietic cell transplant (HCT) or solid organ transplant (SOT) who failed first-line treatment with Roche's Rituxan (rituximab).
One- and three-year overall survival (OS) rates were 68% and 55%, respectively, in EBV+PTLD patients following HCT. Median OS was not reached after 23.3 months of follow-up, significantly greater than the expected 16 - 56 days for this patient population.
In EB+PTLD patients following SOT, one- and three-year OS rates were 64% and 43%, respectively. Median survival was 21.3 months, also superior to the expected survival of a median of 12-13 months.
Overall response rates in the two groups of patients were 69% and 50%, respectively.
Two Phase 3 trials are in process.
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