ASH: Servi­er un­veils full dataset for Tib­so­vo in spe­cif­ic AML mu­ta­tions, and the FDA ap­pears a stone's throw away

Back in Au­gust, Servi­er re­vealed that a Phase III study for Tib­so­vo saw re­sults so ef­fi­ca­cious that in­ves­ti­ga­tors rec­om­mend­ed stop­ping the tri­al ear­ly. Now at ASH, ob­servers are get­ting a view at what ex­act­ly caused the halt.

Look­ing at Tib­so­vo in com­bi­na­tion with chemo com­pared to place­bo and chemo, Servi­er re­port­ed Sat­ur­day that their drug com­bi­na­tion re­sult­ed in sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in event-free sur­vival and over­all sur­vival. The p-val­ues came in sol­id as well, with Tib­so­vo notch­ing val­ues of p=0.0011 and p=0.0005 for each of the re­spec­tive mea­sures.

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