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CodeBreaK100: Sotorasib for KRAS-Mutated Lung Cancer

By: Kayci Reyer
Posted: Monday, August 9, 2021

According to findings from the phase II CodeBreaK100 trial, presented in The New England Journal of Medicine, treatment with the KRAS inhibitor sotorasib resulted in durable clinical benefit for many patients with KRAS G12C–mutated non–small cell lung cancer (NSCLC). Ramaswamy Govindan, MD, of the Washington University School of Medicine, St. Louis, and colleagues had observed anticancer activity in a subset of patients with NSCLC during the phase I portion of the trial.

The study included 126 previously treated patients with KRAS G12C–mutated advanced NSCLC, 124 of whom were considered evaluable due to the presence of measurable disease at baseline. Most of the enrolled patients (81%) had previously undergone platinum-based chemotherapy plus PD-1 or PD-L1 therapy. All patients received 960 mg of oral sotorasib treatment once per day.

A total of 46 patients (47.1%) achieved an objective response, with 4 (3.2%) achieving a complete response and the remaining 42 (33.9%) reaching partial response. Including patients who achieved an objective response with those who reached disease stability yielded a disease control rate of 80.6%. The median duration of response was 11.1 months. The median progression-free and overall survival were 6.8 months and 12.5 months, respectively. Of the 88 patients (69.8%) who experienced treatment-related adverse events, 25 (19.8%) sustained grade 3 adverse events. A grade 4 event was recorded in a single patient (0.8%).

“Efforts are ongoing to investigate sotorasib in combination therapies (CodeBreaK101; ClinicalTrials.gov identifier NCT04185883) and to identify patients who may benefit from sotorasib regimens in the context of first-line treatment,” noted the authors.

Disclosure: For full disclosures of the study authors, visit nejm.org.



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