No­var­tis, BeiGene lay out front­line PhI­II da­ta for PD-1 drug as sec­ond-line PDU­FA date looms

As the FDA pre­pares to de­cide on No­var­tis and BeiGene’s PD-1 drug tislelizum­ab in the sec­ond-line set­ting, the pair is al­ready prepar­ing for its po­ten­tial use as pa­tients’ first treat­ment op­tion.

The two com­pa­nies an­nounced at an ES­MO con­gress on gas­troin­testi­nal can­cer Thurs­day that first-line pa­tients on the an­ti-PD-1 an­ti­body plus chemother­a­py re­port­ed a me­di­an over­all sur­vival of 17.2 months ver­sus 10.6 months for pa­tients on chemo plus place­bo. This meets the study’s pri­ma­ry end­point of over­all sur­vival. The risk of death in pa­tients on the PD-1 drug was al­so 34% low­er than pa­tients on place­bo, clock­ing in a p-val­ue of un­der 0.0001.

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