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Clinical trial results reported Monday by Amgen may be enough to confirm the U.S. approval of its KRAS-targeting lung cancer drug called Lumakras. But the new data also show lung cancer patients are not benefiting from Lumakras as much as previously hoped, and liver toxicity remains a safety concern.

In the study, called CodeBreaK 200, Lumakras delayed tumor growth by a little more than one month compared to the standard chemotherapy, docetaxel — a lower-than-expected improvement that nonetheless achieved the main efficacy goal.


Just as notably, a secondary analysis of overall survival trended in the wrong direction. Lung cancer patients given docetaxel lived longer by three weeks compared to patients offered Lumakras. Amgen said the study was not designed with enough statistical power to demonstrate a Lumakras survival benefit, but delivering a survival outcome worse than docetaxel is a significant setback.

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