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Association details:
| Biomarker: | EGFR S768I |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Tagrisso (osimertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
03/16/2022
Excerpt:
The NCCN NSCLC Panel has preference stratified the systemic therapy regimens and decided that afatinib or osimertinib are preferred options for patients with metastatic NSCLC and EGFR L861Q, G719X, and S768I mutations…
Source:
Title:
A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)
Excerpt:
...Confirmation by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR mutation resulting in substitution of threonine with methionine at amino acid position 790 in exon 20 of EGFR (T790M) or uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort)....
Trial ID:
Source:
Title:
Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm
Excerpt:
...At least one documented uncommon EGFR mutation of G719X/L861Q/S768I/de novo T790M without EGFR Ex19del/L858R/exon 20 insertion as detected in tumour tissue, through real-time PCR or NGS analysis from accredited laboratories approved by the Chinese regulatory authority....
Trial ID:
More C2 evidence
Source:
Title:
A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations
Excerpt:
...- EGFR mutations as performed on a CLIA certified laboratory demonstrating EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q....
Trial ID:
Source:
Title:
Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Excerpt:
...EGFR activating mutations include exon19 deletion, T790M, L858R, G719X, L861Q, or S768I....
Trial ID:
Source:
Title:
Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
Excerpt:
...The tumour harbors at least 1 of the 4 uncommon EGFR mutations (G719X/L861Q/S768I/T790M), either alone or in combination, which...
Trial ID:
Source:
Title:
The Efficacy and Safety of Osimertinib with Platinum plus Pemetrexed Chemotherapy, as First-Line Treatment in Recurrent or Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients with Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm): A Phase II, Open Label, Single Arm, Multicenter, Exploratory 
Excerpt:
...According to the ARMS or Super-ARMS or NGS test results of tumor tissue or plasma from a certified laboratory approved by Chinese regulatory authorities, the tumor carries at least one of the 4 rare EGFR mutations (G719X/L861Q/S768I/T790M) (single mutation or compound mutation), but not other EGFR mutations (including ex19del/L858R). ...
Trial ID:
Source:
Title:
OCEANiC: A Phase II, Open-label, Multi-centre Clinical Trial of Osimertinib With or Without Adjuvant Chemotherapy Guided by Tumour NGS Co-mutation Status and ctDNA Detection in Patients WithnStage IIA-IIIA EGFR-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection
Excerpt:
...These include exon 19 deletions, L858R (exon 21), G719X (exon 18), L861Q (exon 21), S768I (exon 20) and T790M (exon 20). ...
Trial ID:
Source:
Title:
Phase II study of 5 years of adjuvant osimertinib in completely resected EGFRm NSCLC Estudio de fase II de 5 años del tratamiento adyuvante con osimertinib en el cáncer de pulmón no microcítico con mutación del receptor del factor de crecimiento epidérmico completamente resecado.
Excerpt:
...Staging will be according to the pTNM (pathologic tumour,node, metastasis) staging system for lung cancer 8) Confirmation by the local laboratory that the tumour harbours 1 of the following EGFRmutations:-1 of the 2 common EGFR mutations (Ex19del, L858R), either alone or incombination with other EGFR mutations including de novo T790M and excluding allexon 20 insertions (Common EGFRm Cohort); or - Uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort).9) Complete surgical resection of the primary NSCLC is mandatory. ...
Trial ID:
Less C2 evidence
Source:
Title:
1327P - First-line osimertinib in patients with EGFR mutated lung cancer with uncommon mutations (OCELOT study – interim analysis)
Published date:
10/16/2023
Excerpt:
This is a multicentered Canadian phase II investigator-initiated study of (cohort A) osimertinib in the third-line (3L) rechallenge of patients with EGFR+ aNSCLC, following 1L treatment with osimertinib and 2L therapy with platinum pemetrexed chemotherapy; and (cohort B) 1L osimertinib in patients with uncommon EGFR mutations (exon 20 insertions are not permitted)....Osimertinib appears to be highly active and well tolerated in patients with the more frequent ‘uncommon’ EGFR mutations (G719X, L861X, and S768I).
Trial ID:
Source:
Title:
145P-UpSwinG: real-world, non-interventional cohort study on TKI activity in patients (pts) with EGFR mutation-positive (EGFRm+) NSCLC with uncommon mutations
Published date:
03/17/2021
Excerpt:
Uncommon mutation categories were: major uncommon (G719X, L861Q, S768I; 73%); compound (35%); ex20ins (12%); T790M (7%); other (9%). Most pts (n = 226; 92%) were treated in 1st-line with an EGFR TKI; 132 (54%), 70 (28%), 35 (14%) and 7 (3%) received afatinib, gefitinib, erlotinib and osimertinib....Overall median OS was 24.4 mos....ORR was 42% overall (major: 50%; compound: 49%; other: 44%; T790M: 20%; ex20ins: 17%); afatinib: 44% (DoR: 12.0 mos); 1st-gen TKIs: 44% (DoR: 11.0 mos)....Response was highest in pts with major uncommon, and/or compound mutations.
Trial ID:
Source:
Title:
An open-label, multicenter, phase II single arm trial of osimertinib in non-small cell lung cancer patients with uncommon EGFR mutation (KCSG-LU15-09).
Excerpt:
The most common mutations are G719A/C/D/S/X (19, 52.8%) followed by L861Q (9, 25%), S7681 (8, 22%), and others (4, 11%). The overall response rate was 50.0% (95% CI 32.8-67.2) and DCR was 88.9% (95% CI 78.1-99.7). Seven patients (77.8%) with L861Q mutation achieved partial response; 10 (52.6%) with G719A/C/D/S/X mutation; three (37.5%) with S768I mutation....Osimertinib showed highly active and durable in NSCLC patients harboring uncommon EGFR mutation with manageable safety profile, consistent with previous reports.
Trial ID:
Source:
Title:
Treatment outcome of atypical EGFR mutations in the German National Network Genomic Medicine Lung Cancer (nNGM)
Excerpt:
Response to treatment was analyzed in three major groups: (i) uncommon mutations (G719X, S7681, L861Q and combinations)....In patients with uncommon EGFR mutations (group 1), median PFS (mPFS) was significantly longer when patients were treated with EGFR-TKI in 1L compared to chemotherapy (HR 0.53; 95% CI 0.30-0.93, P = 0.028…. Afatinib was the most frequently applied EGFR-TKI in this group (36/79 treatments, 46%), followed by erlotinib (22/79 treatments, 28%), gefitinib (13/79 treatments, 16%) and osimertinib (8/79 treatments, 10%) (Figure 3A).
DOI:
https://doi.org/10.1016/j.annonc.2022.02.225
Source:
Title:
Successful treatment of a patient with NSCLC carrying uncommon compound EGFR G719X and S768I mutations using osimertinib: A case report
Published date:
06/04/2020
Excerpt:
In this study, we reported the postoperative outcome of a patient with NSCLC and uncommon compound EGFR G719X and S768I mutations. After postoperative recurrence, the patient was treated with osimertinib, and an excellent and long-lasting clinical response was achieved. The patient has taken osimertinib for 31.0 months and exhibited a partial response...
DOI:
10.1177/0300060520928793
