^
Association details:
Evidence:
Evidence Level:
Resistant: B - Late Trials
Source:
Title:

Biomarker subgroup analyses of CodeBreaK 200, a phase 3 trial of sotorasib versus (vs) docetaxel in patients (pts) with pretreated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC).

Published date:
05/25/2023
Excerpt:
CONTRADICTING EVIDENCE: Most prevalent KRAS G12C co-alterations in biomarker-evaluable cases with available tumor and/or plasma samples (n=317) were TP53 (181 [57.1%]), STK11 (119 [37.5%]), and KEAP1 (82 [25.9%]) in CodeBreaK 200...Sotorasib showed superior clinical benefit vs docetaxel independently of PD-L1 expression and across all prespecified subgroups (eg, STK11,KEAP1, TP53)....Sotorasib demonstrated consistent clinical benefit vs docetaxel in all prespecified molecularly-defined subgroups (eg, STK11,KEAP1, TP53) in this exploratory analysis of CodeBreaK 200.
DOI:
10.1200/JCO.2023.41.16_suppl.9008
Trial ID:
Evidence Level:
Resistant: C3 – Early Trials
Source:
Title:

1405P - Sotorasib in KRAS G12C-mutated NSCLC: A multicenter real-world experience from the expanded access program in Germany

Published date:
10/16/2023
Excerpt:
Patients with KRAS p.G12C-mutated advanced or metastatic NSCLC received sotorasib within the German multicenter sotorasib expanded access program between April 2021 to February 2022….Response to sotorasib was lower among patients with a positive PD-L1 expression (TPS ≥1%) and a co-occurring KEAP1 mutation, respectively.
Evidence Level:
Resistant: C3 – Early Trials
Title:

Clinical and Genomic Features of Response and Toxicity to Sotorasib in a Real-World Cohort of Patients With Advanced KRAS G12C-Mutant Non-Small Cell Lung Cancer

Published date:
06/29/2023
Excerpt:
Among 105 patients with advanced KRAS G12C-mutant NSCLC treated with sotorasib, treatment led to a 5.3-month median rwPFS, 12.6-month median OS, and 28% real-world response rate. KEAP1 comutations were associated with shorter rwPFS and OS (rwPFS hazard ratio [HR], 3.19; P = .004; OS HR, 4.10; P = .003....Among patients treated with sotorasib in routine practice, KEAP1 comutations were associated with resistance and recent anti-PD-(L)1 therapy exposure was associated with toxicity.
DOI:
10.1200/PO.23.00030
Evidence Level:
Resistant: C3 – Early Trials
Source:
Title:

Clinical and genomic predictors of response and toxicity to sotorasib in a real-world cohort of patients with advanced KRAS G12C-mutant non-small cell lung cancer.

Published date:
05/25/2023
Excerpt:
105 pts with advanced KRAS G12C-mutant NSCLC treated with sotorasib were identified….KEAP1 co-mutations were associated with shorter rwPFS and OS (rwPFS HR 3.19, P = 0.004; OS HR 4.10, P = 0.003);...
DOI:
10.1200/JCO.2023.41.16_suppl.9083
Evidence Level:
Resistant: C3 – Early Trials
Title:

MA14.03-Genomic Profiles and Potential Determinants of Response and Resistance in KRAS p.G12C-mutated NSCLC Treated With Sotorasib

Published date:
08/18/2021
Excerpt:
Here, we report preliminary data on the genomic profiles and potential determinants of response to sotorasib from an exploratory analysis of this trial….In this descriptive biomarker analysis of baseline tissue specimens from the phase 2 CodeBreaK 100 trial of sotorasib in KRAS p.G12C-mutated NSCLC, diverse mutation patterns were observed. The presence of KEAP1 mutation was observed across all groups and was more prevalent in early progressors.
Trial ID: