Merck touts topline PhIII Keytruda data in pre-surgery breast cancer treatment

Mer­ck’s block­buster an­ti-PD-1 ther­a­py Keytru­da is inch­ing its way to­ward an­oth­er po­ten­tial in­di­ca­tion, this time a chemother­a­py com­bo pre-surgery in pa­tients with high-risk, ear­ly-stage ER+/HER2- breast can­cer.

While Mer­ck did not share spe­cif­ic da­ta from its in­ter­im analy­sis of its Phase III KEYNOTE-756 tri­al, the phar­ma said the drug com­bo hit one of the dual pri­ma­ry end­points: show­ing a “sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment” in patho­log­i­cal com­plete re­sponse (pCR) rate com­pared to a place­bo plus chemo in the 1,240-pa­tient tri­al. A pCR is “a lack of all signs of can­cer” fol­low­ing neoad­ju­vant ther­a­py and surgery.

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