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Company:
Guardant HealthType:
Laboratory Developed Test
Related tests:
Evidence Level:
Sensitive: B - Late Trials
[TMB-H-Non Small Cell Lung Cancer-M7824]
Source:
Test:
GuardantOMNI
Title:
Retrospective clinical analysis of circulating tumor DNA (ctDNA)–based molecular response (MR) and baseline blood-based tumor mutational burden (bTMB) for monitoring response in phase 3 trial of bintrafusp alfa vs. pembrolizumab treatment of non-small cell lung cancer (NSCLC).
Published date:
05/25/2023
Excerpt:
ctDNA was collected at baseline and day 42 after treatment with bintrafusp alfa (Q2W, 1200mg) or pembrolizumab (Q3W, 200mg)....In the bintrafusp alpha arm, PFS was significantly longer in patients with bTMB-H (median 8.3 months vs 2.7 months, p = 0.00086).
DOI:
10.1200/JCO.2023.41.16_suppl.9098
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
[TMB-H-Non Small Cell Lung Cancer-durvalumab + tremelimumab]
Source:
Title:
A Blood-based Assay for Assessment of Tumor Mutational Burden in First-line Metastatic NSCLC Treatment: Results from the MYSTIC Study
Published date:
12/22/2020
Excerpt:
The dataset used for the clinical validation was from MYSTIC, which evaluated first-line durvalumab (anti-PD-L1 antibody) ± tremelimumab (anticytotoxic T-lymphocyte-associated antigen-4 antibody) or chemotherapy for metastatic NSCLC....Using the new bTMB algorithm and an optimal bTMB cutoff of ≥20 mut/Mb, high bTMB was predictive of clinical benefit with durvalumab + tremelimumab versus chemotherapy.
DOI:
10.1158/1078-0432.CCR-20-3771
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
[TMB-H-Squamous Cell Carcinoma of Head and Neck-durvalumab + tremelimumab]
Source:
Test:
GuardantOMNI
Title:
Tumor Mutational Burden in Blood May Predict Immunotherapy Response in Head, Neck Cancer
Published date:
06/04/2020
Excerpt:
At the 18-month mark, overall survival rates were significantly higher among TMB-high patients who were treated with durvalumab and durvalumab-tremelimumab than those treated with chemotherapy.
Evidence Level:
Sensitive: B - Late Trials
[TMB-H-Squamous Cell Carcinoma of Head and Neck-durvalumab]
Source:
Test:
GuardantOMNI
Title:
Tumor Mutational Burden in Blood May Predict Immunotherapy Response in Head, Neck Cancer
Published date:
06/04/2020
Excerpt:
At the 18-month mark, overall survival rates were significantly higher among TMB-high patients who were treated with durvalumab and durvalumab-tremelimumab than those treated with chemotherapy.
Evidence Level:
Sensitive: C3 – Early Trials
[TMB-H + PD-L1 expression-Non Small Cell Lung Cancer-nivolumab + ipilimumab]
Source:
Title:
2MO - First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in metastatic non-small cell lung cancer (mNSCLC): clinical outcomes and biomarker analyses from CheckMate 592
Published date:
12/01/2022
Excerpt:
BL characteristics were generally similar between Part 1 (n = 60) and Part 2 (n = 170), and across tTMB and bTMB subgroups. At 12.5-mo minimum follow up, ORR in Part 1 was 30% and 39% in PD-L1 ≥1% (n = 30) and <1% (n = 28) subgroups, respectively. ORR by TMB (Parts 1 and 2 combined) is shown in the table....In CheckMate 592, high tTMB and bTMB were associated with better responses to 1L NIVO + IPI in pts with mNSCLC.
Trial ID:
Evidence Level:
Resistant: C3 – Early Trials
[SMAD4 R361C-Lung Cancer-larotrectinib]
Source:
Test:
Guardant360® CDx, GuardantOMNI
Title:
Updated efficacy and ctDNA analysis of patients with TRK fusion lung cancer treated with larotrectinib
Published date:
03/23/2022
Excerpt:
ctDNA datawere available for 14 evaluable pts; 13 in which somatic alterations were detected. ctDNA analysis detected NTRK gene fusions in 46% of the pts at treatment start. Bythe data cut-off, 6 pts had a progression event with ctDNA data available for 5 pts. Potential acquired mutations were identified in 3 pts: one with NTRK1 F589L and G595R, one with SMAD4 R361C and the third with ARID1A K1238fs and FGFR2 R210Q mutations.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
[NTRK1 fusion-Lung Cancer-larotrectinib]
Source:
Test:
Guardant360® CDx, GuardantOMNI
Title:
Updated efficacy and ctDNA analysis of patients with TRK fusion lung cancer treated with larotrectinib
Published date:
03/23/2022
Excerpt:
ctDNA datawere available for 14 evaluable pts; 13 in which somatic alterations were detected. ctDNA analysis detected NTRK gene fusions in 46% of the pts at treatment start. Bythe data cut-off, 6 pts had a progression event with ctDNA data available for 5 pts. Potential acquired mutations were identified in 3 pts: one with NTRK1 F589L and G595R, one with SMAD4 R361C and the third with ARID1A K1238fs and FGFR2 R210Q mutations.
Trial ID:
Evidence Level:
Resistant: C3 – Early Trials
[NTRK1 F589L + NTRK1 G595R-Lung Cancer-larotrectinib]
Source:
Test:
Guardant360® CDx, GuardantOMNI
Title:
Updated efficacy and ctDNA analysis of patients with TRK fusion lung cancer treated with larotrectinib
Published date:
03/23/2022
Excerpt:
ctDNA datawere available for 14 evaluable pts; 13 in which somatic alterations were detected. ctDNA analysis detected NTRK gene fusions in 46% of the pts at treatment start. Bythe data cut-off, 6 pts had a progression event with ctDNA data available for 5 pts. Potential acquired mutations were identified in 3 pts: one with NTRK1 F589L and G595R, one with SMAD4 R361C and the third with ARID1A K1238fs and FGFR2 R210Q mutations.
Trial ID:
Evidence Level:
Resistant: C3 – Early Trials
[ARID1A K1238fs + FGFR2 R210Q-Lung Cancer-larotrectinib]
Source:
Test:
Guardant360® CDx, GuardantOMNI
Title:
Updated efficacy and ctDNA analysis of patients with TRK fusion lung cancer treated with larotrectinib
Published date:
03/23/2022
Excerpt:
ctDNA datawere available for 14 evaluable pts; 13 in which somatic alterations were detected. ctDNA analysis detected NTRK gene fusions in 46% of the pts at treatment start. Bythe data cut-off, 6 pts had a progression event with ctDNA data available for 5 pts. Potential acquired mutations were identified in 3 pts: one with NTRK1 F589L and G595R, one with SMAD4 R361C and the third with ARID1A K1238fs and FGFR2 R210Q mutations.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
[NTRK3 fusion-Lung Cancer-larotrectinib]
Source:
Test:
Guardant360® CDx, GuardantOMNI
Title:
Updated efficacy and ctDNA analysis of patients with TRK fusion lung cancer treated with larotrectinib
Published date:
03/23/2022
Excerpt:
ctDNA datawere available for 14 evaluable pts; 13 in which somatic alterations were detected. ctDNA analysis detected NTRK gene fusions in 46% of the pts at treatment start. Bythe data cut-off, 6 pts had a progression event with ctDNA data available for 5 pts. Potential acquired mutations were identified in 3 pts: one with NTRK1 F589L and G595R, one with SMAD4 R361C and the third with ARID1A K1238fs and FGFR2 R210Q mutations.
Trial ID:
