Take­da slammed with sur­prise PhI­II fail­ure on 'break­through' blood can­cer drug, im­plod­ing launch plans

One of Take­da’s “break­through” drugs has hit a snag.

In the Phase III PAN­THER study, pevonedi­s­tat — which works by in­hibit­ing the NEDD8-ac­ti­vat­ing en­zyme — failed the pri­ma­ry end­point of event-free sur­vival. And it’s prompt­ing an eval­u­a­tion of the en­tire clin­i­cal pro­gram.

Pa­tients were giv­en ei­ther a com­bi­na­tion of pevonedi­s­tat and the chemother­a­py azac­i­ti­dine, or azac­i­ti­dine alone.

The group com­pris­es pa­tients with three dif­fer­ent con­di­tions: high­er-risk myelodys­plas­tic syn­dromes, chron­ic myelomono­cyt­ic leukemia and low-blast acute myeloid leukemia. For those with HR-MDS or CMML, an event was de­fined as death or trans­for­ma­tion to AML. For par­tic­i­pants with AML, mean­while, an event refers to death.

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