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Association details:
| Biomarker: | EGFR exon 20 insertion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Tagrisso (osimertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
Excerpt:
...- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q)....
Source:
Title:
Osimertinib in Treating Patients With Stage IIIB-IV or Recurrent Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
Excerpt:
...- An EGFR exon 20 insertion mutation must be detected in the tumor tissue; patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay -...
Trial ID:
More C2 evidence
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:
Source:
Title:
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer
Excerpt:
...Group 4: Patient has a documented EGFR Exon20ins activating mutation....
Source:
Title:
First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer
Excerpt:
...Documented EGFR mutation in exon 18-21, except insertions in exon 20, based on tissue analysis....
Trial ID:
Source:
Title:
Osimertinib for NSCLC With Uncommon EGFR Mutations
Excerpt:
...Uncommon mutation of EGFR (exon 20 insertion excluded) 5....
Trial ID:
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:
Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC
Excerpt:
...- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q)....
Source:
Title:
Patients on osimertinib with EGFR mutation exon 20, non-T790M in lung cancer. The position-20 trial.
Excerpt:
...Presence of an EGFR exon 20, non-T790M, mutation, deletions and/or insertion only, 5. ...
Trial ID:
Source:
Title:
A Study of Osimertinib with or without Chemotherapy versus Chemotherapy alone as neoadjuvant therapy for Patients with Epidermal Growth Factor Receptor mutation positive resectable Non-Small Cell Lung Cancer
Excerpt:
...For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.- Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a Mulit-disciplinary Team (MDT) evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).`...
Trial ID:
Source:
Title:
Osimertinib as First-line Therapy for Patients With Late-stage Lung Cancer
Excerpt:
...Patients with EGFR mutation(any form of EGFR mutation subtype except for EGFR exon 20 insertion mutation) detected by First generation sequencing(Sager sequencing) or next generation sequencing(NGS) from tissue sample includes fresh tissue or formalin-fixed paraffin-embedded(FFPE)sample or body fluid sample(blood, pleural effusion, cerebrospinal fluid ,etc.) 3....
Less C2 evidence
Source:
Title:
Osimertinib in NSCLC With Atypical EGFR-Activating Mutations: A Retrospective Multicenter Study
Published date:
01/09/2023
Excerpt:
The most frequent EGFR mutations were L861Q (40%, n = 18), G719X (28%, n = 14), and exon 20 insertion (14%, n = 7). The median TTD of osimertinib was 9.7 months (95% confidence interval [CI]: 6.5-12.9 mo) overall and 10.7 months (95% CI: 3.2-18.1 mo) in the first-line setting (n = 20). The objective response rate was 31.7% (95% CI: 18.1%-48.1%) overall and 41.2% (95% CI: 18.4%-67.1%) in the first-line setting....Osimertinib has activity in patients with NSCLC harboring atypical EGFR mutations.
DOI:
https://doi.org/10.1016/j.jtocrr.2022.100459
Source:
Title:
High dose osimertinib in patients with advanced stage EGFR exon 20 mutation-positive NSCLC: results from the phase 2 multicenter POSITION20 trial
Published date:
06/22/2022
Excerpt:
The POSITION20 is a single arm phase II, multicenter study investigating 160 mg osimertinib in patients with EGFRex20+, T790M negative NSCLC….The ORR was 28% (95% CI, 12-49%), including seven partial responses, with a median DoR of 5.3 months (range, 2.7-27.6). The median PFS was 6.8 months (95% CI, 4.6-9.1) and the median OS was 15.2 months (95% CI, 14.3-16.0).
DOI:
https://doi.org/10.1016/j.lungcan.2022.06.012
Trial ID:
Source:
Title:
1214P-High dose osimertinib in patients with advanced stage EGFR exon 20 mutation-positive NSCLC: Results from a phase II multicenter study, POSITION20
Published date:
09/13/2021
Excerpt:
The POSITION20 study shows antitumor activity in EGFRex20+ NSCLC patients treated with 160mg osimertinib, with an ORR of 27%. The TRAEs are consistent with other reports.
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:
CT106 - Phase I/II study of osimertinib in EGFR exon 20 insertion mutations in non-small cell lung cancer patients: AEX20.
Published date:
03/10/2021
Excerpt:
CONTRADICTING EVIDENCE: Regular dose of osimertinib has limited clinical activity in NSCLC patients with EGFR ex20ins.
Source:
Title:
ECOG-ACRIN 5162: A phase II study of osimertinib 160 mg in NSCLC with EGFR exon 20 insertions.
Published date:
05/13/2020
Excerpt:
...Among the 20 eligible pts, the best response was PR in 4 pts and CR in one pt, for a confirmed ORR of 25%; 12 (60%) pts had SD. The median PFS was 9.7 months (95% CI, 4.07, NA), median duration of response (DOR) was 5.7 months (95% CI, 4.73, NA.)...Osimertinib 160mg daily is well-tolerated and showed clinical activity in EGFR ins20-mutant NSCLC with a response rate of 25%, disease control rate of 85%, and mPFS of 9.7 months.
DOI:
10.1200/JCO.2020.38.15_suppl.9513
Trial ID:
Source:
Title:
Osimertinib in non-small cell lung cancer (NSCLC) with atypical EGFR activating mutations: A retrospective multicenter study.
Published date:
05/13/2020
Excerpt:
...Fifty-one NSCLC pts with uncommon EGFR mutations...The most frequent mutations were L861Q (35.3%, N=18), G719X (27.5%, N=14), and Exon 20 ins (15.7%, N=8).Osi was used in the 1L setting in 39.2% (N=20).Median time on osi was 7.1 months (mo.) in the overall cohort (95% CI, 5.4 to 8.8 mo.) and 8.9 mo.(95% CI, 7.0 to 10.8 mo.) in pts receiving 1L osi. Patients harboring G719X (N=4) and L861Q (N=10) mutations had a median time on 1L osimertinib of 5.8 mo. and 19.3 mo.,respectively.One patient’s tumor had an EGFR exon 19 ins and was on 1L osi with a partial response for 16.8 months.Two patients with Exon 20 ins were on 1L osi for 9.3 mo. and 8 mo.,respectively....Patients with L861Q and Exon 19 insertion appeared to benefit the most from osi in this time on treatment retrospective analysis.
DOI:
10.1200/JCO.2020.38.15_suppl.9570
Source:
Title:
Osimertinib treatment for patients with EGFR exon 20 insertion positive non-small cell lung cancer
Published date:
10/09/2018
Excerpt:
17 patients with advanced NSCLC harboring an EGFR exon 20 insertion were treated with osimertinib 80 mg...Median PFS was 3.7 months (95% CI: 2.3 – 5.4 months). Six of seventeen patients (35%) achieved DCR at five months.
Source:
Title:
EGFR exon 20 insertion mutations and response to osimertinib in non-small-cell lung cancer
Excerpt:
EGFRex20ins mutations were identified in 4.8% (53/1095) of EGFR mutant NSCLC and 2.3% (53/2316) of all NSCLC cases. The most frequently identified EGFRexon20ins is A767_V769dup (17/53,32.1%)...Four patients with osimertinib therapy achieved partial response and the rest stable disease. Median progression free survival (PFS) was 6.2 months (95% confidence interval 5.0-12.9 months; range 4.9-14.6 months).
