Pfiz­er, Mer­ck KGaA clinch need­ed ap­proval for Baven­cio, di­rect­ly com­pet­ing against Keytru­da in kid­ney can­cer

Less than a month af­ter Mer­ck notched an ear­ly OK to mar­ket a Keytru­da com­bo as front­line ther­a­py for re­nal cell car­ci­no­ma, ri­vals Pfiz­er and Mer­ck KGaA have ar­rived at the scene with its own FDA ap­proval.

As is the case with Keytru­da, their PD-L1 in­hibitor Baven­cio is sanc­tioned for use with In­ly­ta, a ty­ro­sine ki­nase in­hibitor from Pfiz­er. In the Phase III JAVELIN Re­nal 101 study, this com­bo demon­strat­ed a sig­nif­i­cant pro­gres­sion-free sur­vival ben­e­fit: five months across the in­tent-to-treat pa­tient pop­u­la­tion com­pared to the com­para­tor arm, who were giv­en Su­tent. That sur­passed the ex­pec­ta­tions of in­ves­ti­ga­tors as they ini­tial­ly nar­rowed the fo­cus to PD-L1 pos­i­tive pa­tients.

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