Abstract

To the Editor: Regarding the report by Fakih et al. (Dec. 7 issue)1 on the CodeBreaK 300 trial of sotorasib in KRAS-mutated colorectal cancer: examination of the data finds problems similar to those identified by the Food and Drug Administration in the CodeBreaK 200 trial of sotorasib in non–small-cell lung cancer.2 The progression-free survival analysis suffers from asymmetric censoring that can disrupt randomization balance if patients who dropped out are predominantly in one trial group. In the first 2 months, data from 11 of 54 patients (20%) assigned to the standard-care group were censored, as compared with 2 patients in .

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