Af­ter falling short on pre­lim OS da­ta, EMA tells Aveo it wants to see some­thing bet­ter on its long suf­fer­ing ti­vo this sum­mer — or else

When Aveo On­col­o­gy scored Eu­ro­pean ap­proval in 2017 for its lead can­cer drug tivozanib — de­spite the treat­ment’s che­quered past — a come­back sto­ry was in the mak­ing. New piv­otal da­ta could now threat­en that ap­proval, and the com­pa­ny’s in­vestors are los­ing pa­tience.

In 2013, da­ta from the 517-pa­tient TI­VO-1 study test­ing tivozanib against so­rafenib in front­line pa­tients with ad­vanced re­nal cell car­ci­no­ma (RCC) showed pa­tients giv­en the Aveo drug did not live as long as those on so­rafenib (me­di­an OS of 28.8 months for tivozanib ver­sus 29.3 months for so­rafenib) — al­though the dif­fer­ence in over­all sur­vival was not sta­tis­ti­cal­ly sig­nif­i­cant (HR=1.245, p=0.105). How­ev­er, tivozanib did meet the main goal of sig­nif­i­cant­ly im­prov­ing pro­gres­sion-free sur­vival (PFS) by a me­di­an of 2.8 months (HR=0.797; P=0.042).

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER