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Clinical, Journal: Prognostic impact of KRAS G12C mutation in patients with NSCLC: results from the ETOP Lungscape Project. (Pubmed Central) - Jul 9, 2021 Updated safety and efficacy data will be presented.). In this large, clinically annotated stage I-III NSCLC cohort, the specific Kr_G12C mutation is significantly associated with poorer prognosis (adjusting for clinicopathological characteristics) among adenocarcinomas as well as in unselected NSCLCs.
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Clinical Trial,Phase II, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Sotorasib for Lung Cancers with KRAS p.G12C Mutation. (Pubmed Central) - Jul 9, 2021 P1/2 In this phase 2 trial, sotorasib therapy led to a durable clinical benefit without new safety signals in patients with previously treated KRAS p.G12C-mutated NSCLC. (Funded by Amgen and the National Institutes of Health; CodeBreaK100 ClinicalTrials.gov number, NCT03600883.).
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Preclinical, Journal: Acquired Resistance to KRAS Inhibition in Cancer. (Pubmed Central) - Jul 9, 2021 P1/2 Diverse genomic and histologic mechanisms impart resistance to covalent KRAS inhibitors, and new therapeutic strategies are required to delay and overcome this drug resistance in patients with cancer. (Funded by Mirati Therapeutics and others; ClinicalTrials.gov number, NCT03785249.).
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FDA event, Journal, PD(L)-1 Biomarker, IO biomarker: FDA Approves First KRAS Inhibitor: Sotorasib. (Pubmed Central) - Jun 24, 2021 The FDA has approved the first KRAS-targeted therapy, sotorasib, for patients with previously treated non-small cell lung cancer with KRASG12C mutations. In a phase II trial, the drug yielded a median progression-free survival of 6.8 months in patients whose disease had advanced despite treatment with standard therapies, namely platinum-based chemotherapy and PD-1-PD-L1 inhibitors.
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Journal: Sotorasib Is Active in KRAS-Mutant Non-Small Cell Lung Cancer. (Pubmed Central) - Jun 22, 2021 Our understanding of the etiology of the rat specific renal toxicity informs the translational risk assessment for patients. Sotorasib produced objective responses in 37.1% of patients for a median duration of 11.1 months.
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Trial completion date, Trial primary completion date, Monotherapy, IO biomarker: CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - Jun 7, 2021 P1b/2, N=1113, Recruiting, The current study suggested that AMG510 may have potential clinical use in combination with MEK and BCL-XL inhibitors in the treatment of patients with colorectal cancer exhibiting the G12C KRAS mutation. Trial completion date: Nov 2025 --> Feb 2028 | Trial primary completion date: Jun 2023 --> Jan 2024
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