^
Association details:
| Biomarker: | EGFR exon 20 insertion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Gilotrif (afatinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
503P - Activity of afatinib in patients (pts) with NSCLC harboring uncommon EGFR mutations: Pooled analysis of three large phase IIIB trials
Published date:
11/24/2019
Excerpt:
Patient had tumors harboring at least one uncommon mutation (exon 20 insertions [Ins20]: n = 70; T790M: n = 20; G719X: n = 41; L861Q: n = 47; S768I: n = 20; other: n = 25. Of note, 35% of pts had Ins20 mutations, a heterogeneous group generally resistant to EGFR TKIs). In those pts with uncommon mutations and brain metastases, median TTSP and PFS were 7.6 mos (95% CI 4.6–10.1) and 7.4 mos (95% CI 4.6–9.1)....Clinical activity in pts with uncommon mutations was greatest against tumors harboring G719X, L861Q or S768I. Some pts with Ins20 or T790M mutations appeared to benefit from treatment.
Source:
Title:
Real-World Clinical Outcomes for Patients with EGFR and HER2 Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer
Published date:
07/25/2023
Excerpt:
Among EGFR ex20ins patients, 71/84 had stage IV disease....Nine out of 10 patients who received poziotinib and all 5 patients who received mobocertinib had either a partial response or stable disease, whereas 3/7 patients who received afatinib had stable disease.
DOI:
https://doi.org/10.3390/curroncol30080515
Source:
Title:
Clinical Outcomes of Afatinib Versus Osimertinib in Patients With Non-Small Cell Lung Cancer With Uncommon EGFR Mutations: A Pooled Analysis
Published date:
04/28/2023
Excerpt:
Uncommon EGFR mutations were categorized into 4 groups: insertion in exon 20 (ex20ins), non-ex20ins single uncommon EGFR mutations, compound EGFR mutations that with 19del or L858R, and compound EGFR mutations without 19del or L858R…the afatinib group showed a significantly superior PFS benefit than the osimertinib group (11.0 vs. 7.0 months, P = .044). In addition, patients harboring non-ex20ins single uncommon EGFR mutations yield the best ORR and PFS, following treatment of either afatinib (ORR: 76.7%, mPFS: 14.1 months) or osimertinib (ORR: 68.8%, mPFS: 15.1 months).
DOI:
10.1093/oncolo/oyad111
Source:
Title:
Afatinib for the Treatment of Non-Small Cell Lung Cancer Harboring Uncommon EGFR Mutations: An Updated Database of 1023 Cases Brief Report
Published date:
04/28/2022
Excerpt:
The distribution of mutation categories was: major uncommon (41.4%); exon 20 insertions (22.3%); T790M (20.3%)….In TKI-naïve patients, afatinib demonstrated activity against major uncommon mutations (median TTF: 12.6 months; ORR: 59.0%), ‘other’ mutations (median TTF: 10.7 months; ORR: 63.9%) including strong activity against E709X (11.4 months; 84.6%) and L747X (14.7 months; 80.0%), and compound mutations (11.5 months; 63.9%). Although sample sizes were small, notable activity was observed against specific exon 20 insertions...
DOI:
10.3389/fonc.2022.834704
Source:
Title:
Real Life Comparison of Afatinib and Erlotinib in Non-small Cell Lung Cancer With Rare EGFR Exon 18 and Exon 20 Mutations: a Turkish Oncology Group (TOG) Study.
Published date:
12/10/2021
Excerpt:
...complex mutations in 24% of the patients with NSCLC who were evaluated for the study...18 patients with exon 20 insertion, 10 patients were male, and 50% were non-smokers. In this group, 7 patients (38.3%) received erlotinib, 6 patients (33.3%) afatinib, and 5 patients (27.7%) gefitinib. Median PFS of the whole group was 8.7 months (95% CI 3.1-14.3). In those who received erlotinib PFS was 7.0 months (95% CI 1.0-14.2), in afatinib treated patients PFS was 8.7 months (95% CI 1.0-20.5), and in gefitinib 15.0 months (95% CI 1.0-24.1) (p=0.479). Median OS was 26.4 months (95% CI 20.0-32.8) for the entire group. It was 24.0 months (95% CI 20.7-27.3) with erlotinib, 31.4 months (95% CI 22.7-40.1) with afatinib, and 28.5 months (95% CI 11.1-46.0) with gefitinib.
DOI:
10.21203/rs.3.rs-1125056/v1
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:
395P - Afatinib in Asian and non-Asian patients (pts) with EGFR mutation positive (EGFRm+) NSCLC harboring major uncommon mutations
Published date:
11/17/2020
Excerpt:
Clinical activity (Asian/non-Asian) was observed against major uncommon mutations (ORR: 66/59%; median DoR: 14.7/15.9 mos; G719X: 62/65%; L861Q: 60/50%; S768I: 80/25%), compound mutations (ORR: 81/100%; median DoR: 11.5/18.6 mos) and other uncommon mutations (ORR: 79/60%; median DoR: 9.0/10.7 mos). Some pts with Ins20 responded (21/23%). TTF was longest in pts with compound mutations, particularly non-Asian pts (median 18.5 mos). Afatinib is effective in pts with NSCLC with major uncommon and compound EGFR mutations, with broad activity against other uncommon EGFR mutations and some Ins20 mutations...
Source:
Title:
1341P - Afatinib in Asian and non-Asian patients (pts) with EGFR mutation-positive (EGFRm+) NSCLC harboring uncommon mutations
Published date:
09/14/2020
Excerpt:
This pooled analysis assessed afatinib activity in Asian/non-Asian, EGFR TKI-naïve pts with NSCLC and uncommon EGFR mutations, treated in RCTs and real-world studies. Uncommon mutations were classed as: de novo T790M; exon 20 insertions (Ins20); major uncommon mutations (G719X/L861Q/S768I)...Afatinib is effective in pts with NSCLC harboring major uncommon and compound EGFR mutations, with broad activity against other uncommon EGFR mutations and some Ins20 mutations, unaffected by ethnicity.
Source:
Title:
Afatinib in Asian and Non-Asian Patients (pts) with EGFR Mutation-Positive (EGFRm+) NSCLC Harboring Major Uncommon Mutations
Excerpt:
Clinical activity (Asian/non-Asian) was observed against major uncommon mutations (ORR: 66/59%; median DoR: 14.7/15.9 mos; G719X: 62/65%; L861Q: 60/50%; S768I: 80/25%), compound mutations (ORR: 81/100%; median DoR: 11.5/18.6 mos) and other uncommon mutations (ORR: 79/60%; median DoR: 9.0/10.7 mos). Some pts with Ins20 responded (21/23%)…Afatinib is effective in pts with NSCLC with major uncommon and compound EGFR mutations, with broad activity against other uncommon EGFR mutations and some Ins20 mutations, unaffected by ethnicity.
