With one BLA at the FDA, Kite hus­tles along im­pres­sive new leukemia da­ta and sounds a note of cau­tion on safe­ty

CHICA­GO — With its lead pro­gram for non-Hodgkin lym­phoma in front of FDA re­view­ers, Kite Phar­ma $KITE to­day up­dat­ed their Phase I CAR-T study on re­lapsed cas­es of acute lym­phoblas­tic leukemia, not­ing a strik­ing­ly high com­plete re­mis­sion rate of 73% as they con­tin­ue to work on im­prov­ing the safe­ty pro­file of their ther­a­py.

The study in­clud­ed 11 pa­tients in the Phase I por­tion of ZU­MA-3. Com­plete re­mis­sions — with the re­spon­ders all test­ing neg­a­tive for min­i­mal resid­ual dis­ease with few or no can­cer cells in cir­cu­la­tion — were be­ing tracked that last­ed from 2 to more than 7.4 months. And the Phase II tri­al will get un­der­way as Kite looks to ex­pand use of its drug KTE-C19.

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