Zymeworks shows pos­i­tive — yet ear­ly — piv­otal da­ta in bile duct can­cers, plans ac­cel­er­at­ed ap­proval run

Zymeworks is show­ing off some new topline da­ta on its HER2 bis­pe­cif­ic an­ti­body — af­ter show­cas­ing a pos­i­tive da­ta turnout at AS­CO ear­li­er in 2022.

The com­pa­ny said Mon­day that 41.3% of pa­tients with HER2-am­pli­fied and ex­pressed dis­ease in a Phase IIb piv­otal tri­al in pa­tients with bil­iary tract can­cers showed an ob­jec­tive re­sponse, with a me­di­an re­sponse of 12.9 months while on zanidatam­ab. Among 80 pa­tients, safe­ty was con­sis­tent to what was seen in pre­vi­ous stud­ies. CEO Ken­neth Gal­braith said on a con­fer­ence call with in­vestors and an­a­lysts Mon­day morn­ing that full re­sults will be pre­sent­ed at an undis­closed med­ical meet­ing some­time in the first half of next year.

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