Atara Bio Unveils Pivotal Data On T Cell Therapy Tabelecleucel In Transplant Patients

Atara Biotherapeutics Inc ATRA posted efficacy and safety results from its Phase 3 ALLELE study of tabelecleucel (tab-cel) for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

  • EBV+ PTLD is a rare complication after a solid organ (SOT) or hematopoietic stem cell transplant (HSCT).
  • The overall response rate was 50% in both the SOT and HCT groups. 
  • 26.3% of patients overall achieved a complete response, and just under 23.7% reached a partial response.
  • Eleven of the 19 responders saw a duration of response longer than six months. 
  • Of the eight remaining responders, four patients experienced either disease progression or death, and four weren't evaluable for a six-month response at the data cut. 
  • Patients who responded to tab-cel survived longer than the non-responders, with a one-year survival rate of 89.2% in the responder group versus 32.4% in the group that didn't respond. Median overall survival wasn't reached in the responder group.
  • The Company also reported long-term results from Phase 2 and EAP trials, showing a median overall survival of 54.6 months. 
  • The overall complete response rate was 42.1%, and the partial response rate was 21.1%. 
  • Two-year survival rates for CR and PR patients were 86.2% and 86.5%, respectively.
  • In November, Atara filed with the EMA and is expecting a decision in 2H of 2022. 
  • Price Action: ATRA shares are up 9.45% at $17.14 during the premarket session on the last check Tuesday.
  • Check out our coverage of the American Society of Hematology (ASH) Annual Meeting 2021 here.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechLong IdeasNewsHealth CareSmall CapMoversTrading IdeasGeneralASH21Briefs
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!