Will a drug allow a patient to live a longer, better life? That question lies at the heart of drug trial outcomes. But sometimes those core goals get buried in the design and interpretation of drug trials. CodeBreaK 200 trial represents a prime example:
Will a drug allow my patient to live a longer, better life? That question lies at the heart of drug trial outcomes.The recentCodeBreaK is a phase 3 randomized controlled trial that evaluated the new targeted drug sotorasib againstG12C mutation positive non–small cell lung cancer who have already progressed on both immunotherapy and chemotherapy — essentially a last-line therapy trial.
Progression-free survival results showed that compared with docetaxel, sotorasib improved median PFS by 1 month . Some of these experts may be confusing excitement surrounding a scientific discovery with the need to celebrate trial results, even when they're not impressive. Yes, being able to drugis a huge scientific discovery. It's also true that the CodeBreaK 200 results are underwhelming. Both statements can simultaneously be true. We don't need to buy into hype.
However, the more surprising fact about this trial was that it was initially appropriately powered for overall survival. The publication mentions that"per regulatory feedback," the protocol was"amended to decrease" the sample size and"only power the trial for PFS," to"limit the overall number of patients treated with docetaxel."
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