Mod­er­na, Mer­ck un­veil three-year mid-stage da­ta for vac­cine-Keytru­da com­bo in melanoma, with PhI­II un­der­way

Mod­er­na and Mer­ck re­port­ed Thurs­day that their per­son­al­ized melanoma can­cer vac­cine plus Keytru­da ap­proach de­liv­ered “con­tin­ued im­prove­ment” in re­duc­ing risk of dis­ease re­cur­rence or death, based on three-year da­ta from a mid-stage tri­al.

But de­bate sur­round­ing the use of one-sided nom­i­nal p-val­ues may sur­face again, much like when the com­pa­nies her­ald­ed suc­cess from a pri­ma­ry analy­sis read­out for the same study. The Phase IIb tri­al re­cruit­ed 157 high-risk pa­tients who had com­plete sur­gi­cal re­sec­tion of their stage 3 or 4 melanoma.

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