BeiGene touts pos­i­tive PhI­II da­ta on tislelizum­ab in af­ter­math of set­backs at FDA

Af­ter the FDA in­def­i­nite­ly de­layed its de­ci­sion on BeiGene’s No­var­tis-part­nered PD-1 drug can­di­date tislelizum­ab as a monother­a­py for esophageal can­cer, No­var­tis an­nounced that it was scrap­ping a sec­ond ap­pli­ca­tion for non-small cell lung can­cer. How­ev­er, BeiGene is hold­ing out hope that there’s yet an­oth­er way to ex­pand the drug’s mar­ket out­side of Chi­na.

BeiGene put out word Tues­day morn­ing that a Phase III open-la­bel glob­al study, named RA­TIO­NALE 301, met its pri­ma­ry end­point of non-in­fe­ri­or over­all sur­vival (OS) ver­sus so­rafenib as a first-line treat­ment in adults with un­re­sectable he­pa­to­cel­lu­lar car­ci­no­ma (HCC). The com­pa­ny claimed that the tri­al, which en­rolled more than 600 pa­tients from the US, Eu­rope and Asia, showed a con­sis­tent safe­ty pro­file from pre­vi­ous stud­ies in­volv­ing tislelizum­ab and re­port­ed no new safe­ty sig­nals.

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