Michael Morrissey, Exelixis CEO

Ex­elix­is posts mixed re­sults for Cabome­tyx com­bo in ear­ly liv­er can­cer pa­tients, cast­ing doubt on piv­otal read­out

Ex­elix­is en­vi­sioned a first-line ap­proval for its su­per-sell­er Cabome­tyx in liv­er can­cer, but af­ter an in­ter­im read­out pro­duced mixed re­sults, that pic­ture is now a bit murky. De­spite fail­ing a key pri­ma­ry end­point, the com­pa­ny’s rac­ing full speed ahead to­ward a fi­nal read­out — and a po­ten­tial la­bel ex­pan­sion.

Cabome­tyx and Tecen­triq re­duced the risk of dis­ease pro­gres­sion or death in he­pa­to­cel­lu­lar car­ci­no­ma (HCC) pa­tients by 37% com­pared with so­rafenib (p= 0.0012), Ex­elix­is said Mon­day morn­ing. How­ev­er, it failed to achieve a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival at the in­ter­im analy­sis, and the com­pa­ny says the prob­a­bil­i­ty of hit­ting the end­point in time for the fi­nal analy­sis is low.

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