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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