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Monday, December 13, 2021

-=Allogene (ALLO) : "positive" Phase 1 data from the ALPHA Trials in Non-Hodgkin's Lymphoma

 

 Allogene reports "positive" Phase 1 data from the ALPHA Trials in Non-Hodgkin's Lymphoma at the 63rd Annual Meeting of the American Society of Hematology
  • ALPHA trials demonstrate potential for AlloCAR T Therapy to be a safe and durable alternative to autologous cell therapy in CAR T nave patients.
  • AlloCAR T Therapy was associated with consistent and manageable safety with no DLTs or GvHD; low rates of Grade 3 ICANs and CRS.
  • No relapses observed in Large B Cell Lymphoma CAR T nave patients across trials who achieved a complete response at six months.
  • Longest ongoing CRs with ALLO-501 at 18+ months and ALLO-501A 15+ Mmonths.
  • Company plans to initiate a Phase 2 pivotal trial in relapsed/refractory LBCL utilizing consolidation 1 dosing with lower cyclophosphamide pending discussion with FDA.
    • Regimen was well tolerated with low rates of adverse events.
    • Yielded a 44% CR rate in LBCL with ongoing CRs at 9 months.
    • Consolidation produced an 88% overall response rate and 75% CR rate in follicular lymphoma.
  • Key advantage of allogeneic delivery established with >97% of patients treated; median time from enrollment to initiation of treatment of five days in ALPHA and two days in ALPHA2.

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