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ASCO 2021: Subgroup Efficacy Analysis of Sotorasib for Advanced KRAS G12C–Mutated NSCLC

By: Julia Fiederlein
Posted: Wednesday, June 9, 2021

According to Ferdinandos Skoulidis, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues, in an exploratory analysis of the phase II CodeBreaK 100 trial, the clinical benefit of the KRAS G12C inhibitor sotorasib was observed across an extended set of patient subgroups with advanced non–small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. Specifically, treatment with sotorasib yielded a 37.1% objective response rate and a median overall survival of 12.5 months in previously treated patients. These results were presented during the virtual edition of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9003) and published in The New England Journal of Medicine.

“These results, along with the regulatory approval of sotorasib, represent a major landmark for patients with KRAS G12C–mutated lung cancer, who now have an approved targeted therapy option,” stated Dr. Skoulidis in an MD Anderson press release.

A total of 124 patients were analyzed; in this population, the objective response rate was 37.1%. In addition, the median overall survival was 12.5 months, with a median duration of response of 11.1 months and median progression-free survival of 6.8 months. Compared with younger patients, the objective response rate was higher in those at least 65 years of age (44.1% vs. 30.8%). The objective response rates were 36.7% and 50.0% in patients with and without metastatic disease, respectively. Patients who did not receive prior anti–PD-1/L1 therapy experienced a higher objective response rate than those who did (45.5% vs. 36.3%).

Compared with patients who harbored the TP53 co-mutation, the objective response rate was higher in those who had wild-type disease (40.0% vs. 39.3%). The objective response rates were 40.0% in patients who harbored the STK11 co-mutation and 39.1% in those who did not. The objective response rates were 20.0% and 44.0% in patients with and without the KEAP1 co-mutation, respectively.

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



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