Kite touts 12-month re­mis­sion da­ta from tiny CAR-T study; Iron­wood ex­ec dies in bike ac­ci­dent

There’s been a con­sid­er­able amount of chat­ter in re­cent days over whether or not Kite $KITE can ex­pect to win an ac­cel­er­at­ed FDA ap­proval for its lead­ing CAR-T drug based on 3 months of re­sponse da­ta. But the biotech is tout­ing its case at ES­MO this week­end, hit­ting hard on pos­i­tive 12-month re­sults from a tiny study to back up their case that KTE-C19 has a durable im­pact on pa­tients. The com­plete re­mis­sion rate for the drug is 43% through a full year of treat­ment, says Kite. And they trum­pet­ed the num­ber as can­cer spe­cial­ists lined up for the big ES­MO meet­ing. “These da­ta com­ple­ment our re­cent­ly re­port­ed in­ter­im topline re­sults from ZU­MA-1 Phase 2 and sup­port the po­ten­tial for KTE-C19 to be a break­through ther­a­py for chemore­frac­to­ry, ag­gres­sive NHL,” said David Chang, Kite’s re­search chief, in a state­ment. “We are en­cour­aged that the com­plete re­mis­sion rate of 43 per­cent in the Phase 1 por­tion of the study con­tin­ues through month 12 and look for­ward to re­port­ing ad­di­tion­al da­ta on the dura­bil­i­ty of re­sponse to KTE-C19 from the Phase 2 por­tion of ZU­MA-1 in 2017.”

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