Af­ter dis­ap­point­ing Wall Street last year, De­nali touts new bio­mark­er da­ta hop­ing to forge clear path to FDA

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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