AJ Joshi, MD, chief medical officer, Atara Biotherapeutics, discussed data from the ALLELE study to be presented at ASH 2021.
“What we're reporting at the ASH meeting is the first interim results from the ALLELE study. Specifically, we're bringing on a population of patients that had received therapy, that we have overall response rate for by independent oncologic radiographic assessment. And then they have also had an opportunity for 6 months follow up so we can really see the durability response in our population.”
Atara Biotherapeutics is reporting updated data from the phase 3 ALLELE study (NCT03394365) of tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) at the upcoming American Society of Hematology 2021 Meeting, December 11-14.
The ALLELE study has enrolled 38 evaluable, heavily pretreated patients with EBV+ PTLD as of May 2021. Independent objective response rate was 50% (95% CI [33.4, 66.6]; n = 19). Median time to response was 1.1 months (range, 0.7-4.7). Eleven patients had a duration of response of at least 6 months. No new safety signals or concerns were reported, and safety findings were consistent with previously published data.
GeneTherapyLive spoke with AJ Joshi, MD, chief medical officer, Atara Biotherapeutics, to learn more about the ALLELE study and the positive data seen in enrolled participants.