Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mi­rati Ther­a­peu­tics $MRTX took an­oth­er close­ly-watched step to­ward a now clear­ly de­fined goal to file for an ap­proval for its KRAS G12C can­cer drug ada­gra­sib (MRTX849), scor­ing a high­er re­sponse rate than the last read­out from the class-lead­ing ri­val at Am­gen but still leav­ing open a raft of im­por­tant ques­tions about its fu­ture.

Fol­low­ing a snap­shot of the first hand­ful of re­spons­es, where the drug scored a tu­mor re­sponse in 3 of 5 pa­tients with non-small cell lung can­cer, the re­sponse rate has now slid to 45% among a pooled group of 51 ear­ly-stage and Phase II pa­tients, 43% — 6 of 14 — when look­ing sole­ly at the Phase I/Ib. Those 14 pa­tients had a me­di­an treat­ment du­ra­tion of 8.2 months, with half still on ther­a­py and 5 of 6 re­spon­ders still in re­sponse.

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