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Sotorasib for lung cancers with KRAS p.G12C mutation

New England Journal of Medicine Jun 09, 2021

Skoulidis F, Li BT, Dy GK, et al. - Whether sotorasib has anticancer activity in patients with KRAS p.G12C–mutated advanced non–small-cell lung cancer (NSCLC) previously treated with standard therapies, was inquired in this single-group, phase 2 trial wherein participants were orally administered sotorasib at a dose of 960 mg once daily. Measurable disease at baseline was present in 124 patients, as per central review, and these were assessed for response. A total of 46 patients were found to have an objective response, including in 4 who exhibited a complete response and in 42 who showed a partial response. Disease control was achieved in 100 patients. The median progression-free survival and median overall survival were 6.8 months and 12.5 months, respectively. Responses were obtained in subgroups characterized based on programmed death ligand 1 expression, tumor mutational burden, and co-occurring mutations in STK11, KEAP1, or TP53. Overall, findings of this study revealed that a durable clinical advantage was conferred by sotorasib therapy, without new safety signals, in patients with previously treated KRAS p.G12C–mutated NSCLC.

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