Orca puts numbers on its Precision-T win

Last month, privately-held Orca Bio announced a pivotal win with its lead project, Orca-T, and now it’s disclosed survival numbers that appear to show the therapy holding up against its phase 1 trial. Orca-T, an engineered cell preparation derived from partially matched donors, could improve tolerance versus allogeneic stem cell transplantation; the phase 3 Precision-T study aimed to show an increase in chronic graft-versus-host disease-free survival with Orca-T plus tacrolimus, compared with conventional alloHSCT plus tacrolimus and methotrexate. This goal was achieved, the latest numbers show. But there are questions about the control arm used in Precision-T because post-transplant cyclophosphamide, the so-called Baltimore regimen, has recently emerged as the standard of care for partially matched transplants. A cross-trial comparison could bolster Orca’s cause: an interim analysis of Precision-T found overall survival of 94% with Orca-T, similar to the 96% seen at one year in phase 1. At ASH last year, Orca cited an 82% OS rate in a historical cohort of alloHSCT plus post-transplant cyclophosphamide – in line with Precision-T’s control arm. Orca plans to file Orca-T with the FDA this year, and present full results from Precision-T at the European Society for Blood and Marrow Transplantation meeting in early April.

One-year results from Precision-T

Note: *interim analysis; **exploratory endpoint. Source: Company release.