Am­gen posts terse up­date on PhI­II Lumakras win — but just how big?

Lumakras, Am­gen’s ground­break­ing KRAS drug, was ap­proved on da­ta from an open-la­bel, sin­gle-arm study sug­gest­ing, among oth­er things, me­di­an pro­gres­sion-free sur­vival of 6.8 months for pa­tients with KRASG12C-mu­tat­ed non-small cell lung can­cer.

Now, Am­gen says it has the first proof that Lumakras beats chemother­a­py — the cur­rent stan­dard of care — on that met­ric.

Fur­ther analy­ses are still on­go­ing and da­ta will be re­served for fu­ture med­ical con­fer­ences, Am­gen said, re­main­ing tight-lipped. What it will say is that the drug, for­mer­ly known as so­tora­sib, met the pri­ma­ry end­point of PFS in the Code­BreaK 200 tri­al, where it went head to head with in­tra­venous do­c­etax­el. Among 345 pa­tients, Lumakras demon­strat­ed “sta­tis­ti­cal sig­nif­i­cance and su­pe­ri­or­i­ty” over the chemo.

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