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Association details:

Evidence:

Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:
Osimertinib for untreated EGFR mutation-positive nonsmall-cell lung cancer
Published date:
10/14/2020
Excerpt:
Osimertinib is recommended, within its marketing authorisation, as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
09/15/2020
Excerpt:
Osimertinib is a preferred first-line EGFR TKI option for patients with EGFR positive metastatic NSCLC…
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
First-line osimertinib is now considered one of the options for patients with a tumour with sensitising EGFR mutations.
DOI:
Ann Oncol (2018) 29 (suppl 4): iv192–iv237
Evidence Level:
Sensitive: B - Late Trials
Title:
Adjuvant EGFR-TKIs for Patients With Resected EGFR-Mutant Non-Small Cell Lung Cancer: A Meta-Analysis of 1,283 Patients
Published date:
04/12/2021
Excerpt:
Resected EGFR-mutant NSCLC patients treated with osimertinib experienced improved DFS and a lower risk of brain recurrence than those treated with gefitinib or erlotinib.
DOI:
10.3389/fonc.2021.629394
Evidence Level:
Sensitive: B - Late Trials
Title:
Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study
Published date:
02/05/2021
Excerpt:
First-line osimertinib treatment resulted in a clinically meaningful PFS and OS benefit versus comparator EGFR TKI in Chinese patients with EGFRm advanced NSCLC.
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:
The role of adjuvant targeted therapy for postoperative EGFR mutant non-small cell lung cancer: A network meta-analysis
Published date:
11/17/2020
Excerpt:
Osimertinib showed the most favorable DFS, with significant superiority versus erlotinib (HR 0.4, 95% CI 0.24-0.66), gefitinib (0.42, 0.26-0.67), chemotherapy (0.23, 0.15-0.33) and placebo (0.17, 0.12- 0.24), but with no significant improvement versus CT +TKI (0.86, 0.42-1.74)....EGFR-TKIs monotherapy provided more survival improvement for patients with exon 19 deletion than with L858R mutation (HR, 0.31 [0.13, 0.75] for exon 19 deletion, and 0.48 [0.35, 0.65] for L858R mutation, respectively).
Evidence Level:
Sensitive: B - Late Trials
Title:
Osimertinib adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) NSCLC (ADAURA): Central nervous system (CNS) disease recurrence
Published date:
11/17/2020
Excerpt:
There was a clinically meaningful improvement in CNS DFS with osimertinib: 82% reduction in risk of CNS disease recurrence or death. Results support that osimertinib reduces risk of CNS recurrence in the resected EGFRm NSCLC setting.
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:
Tagrisso granted Priority Review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
Published date:
10/20/2020
Excerpt:
AstraZeneca’s Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
Evidence Level:
Sensitive: B - Late Trials
Title:
Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer
Published date:
09/19/2020
Excerpt:
In this double-blind, phase 3 trial, we randomly assigned patients with completely resected EGFR mutation-positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years….In patients with stage IB to IIIA EGFR mutation-positive NSCLC, disease-free survival was significantly longer among those who received osimertinib than among those who received placebo.
DOI:
10.1056/NEJMoa2027071
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:
Tagrisso granted Breakthrough Therapy Designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer
Published date:
07/30/2020
Excerpt:
AstraZeneca’s Tagrisso (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent....The FDA granted the BTD based on data from the Phase III ADAURA trial, which were also recently presented during the plenary session of the American Society of Clinical Oncology ASCO20 Virtual Scientific Program.
Evidence Level:
Sensitive: B - Late Trials
Title:
Tagrisso demonstrated unprecedented disease-free survival in the adjuvant treatment of Stage IB-IIIA patients with EGFR-mutated lung cancer
Published date:
05/28/2020
Excerpt:
...Phase III ADAURA trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
Evidence Level:
Sensitive: B - Late Trials
Title:
Tagrisso granted breakthrough therapy designation by US FDA for the 1st-line treatment of patients with EGFR mutation-positive non-small cell lung cancer
Published date:
10/09/2017
Excerpt:
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:
Afatinib Osimertinib Sequencing NIS
Excerpt:
...Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:
Survival analysis for older patients with epidermal growth factor receptor mutation-positive advanced non-small cell lung cancer after progression of first-line gefitinib
Published date:
04/27/2021
Excerpt:
...osimertinib only group had significantly improved OS compared with chemotherapy or palliative care only groups (37.5 versus 17.5 and 15.3 months, respectively; P = .017)....Multivariate analysis showed that continuous gefitinib after Response Evaluation Criteria in Solid Tumor‐defined PD (hazards ratio [HR] 0.273, 95% CI: 0.132‐0.564, P < .001), osimertinib treatment (HR 0.244, 95% CI: 0.122‐0.487, P < .001), and better performance status (HR 0.360, 95% CI: 0.163‐0.796, P = .012) were significantly and independently correlated with better survival.
DOI:
https://doi.org/10.1111/ajco.13546
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
151P - Osimertinib versus Standard-of-care EGFR-TKI as First-line Treatment for Advanced NSCLC with EGFR-positive Mutation Patients: A Systematic Review
Published date:
03/17/2021
Excerpt:
...998 patients claimed that osimertinib showed efficacy superior to the standard EGFR TKIs used in the first-line treatment of advanced EGFR mutation-positive NSCLC.
Evidence Level:
Sensitive: C3 – Early Trials
Title:
P76.01 - Impact of Clinicopathological Features on Efficacy of Osimertinib in Advanced NSCLC Patients With EGFR Mutations
Published date:
01/12/2021
Excerpt:
…advanced EGFR mutated NSCLC patients...The longer PFS of prior first-generation EGFR-TKI might also result in the longer PFS of osimertinib. Moreover, active-EGFR MAF, T790M MAF and T790M/active-EGFR MAF ratio might be potential markers of outcome in patients treated with osimertinib.
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Survival outcomes and symptomatic central nervous system (CNS) metastasis in EGFR-mutant advanced non-small cell lung cancer without baseline CNS metastasis: Osimertinib vs. first-generation EGFR tyrosine kinase inhibitors
Published date:
11/05/2020
Excerpt:
There were 813 patients enrolled, with 562, 106, and 32 received first-line gefitinib, erlotinib, and osimertinib, respectively, while 113 received second-line osimertinib. At a median follow-up of 18.1 months, the median OS was 45.5 months.
DOI:
10.1016/j.lungcan.2020.10.018
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Dose escalation of osimertinib for intracranial progression in EGFR mutated non-small-cell lung cancer with brain metastases
Published date:
09/24/2020
Excerpt:
This is a subcohort analysis from a larger nonrandomized, phase 2, open-label trial, evaluating the efficacy of osimertinib dose escalation from 80 mg to 160 mg in EGFR-mutated advanced non-small-cell lung cancer (NSCLC) patients with intracranial progression in either first- (arm A) or second-line setting (arm B for T790M+ and C for T790M-)....Eleven patients, 5 in arm A, 4 in arm B, and 2 in arm C were reported in this study....The mPFS of osimertinib before dose escalation was 11.4 ± 8.9 (6.6-30.7) months for arm A, 8.7 ± 1.8 (6.3-11.2) for arm B, and 14.5 ± 7.8 (6.7-22.3) for arm C....Median iPFS was 4.3 ± 7.4 (0.7-25.5) months; 3.8 ± 6.4 (1.8-18.9), 5.6 ± 9.7 (0.7-25.5), and 7.0 ± 2.7 (4.3-9.6) for arms A/B/C, respectively.
DOI:
10.1093/noajnl/vdaa125
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Overall survival of super-elderly (85 years or older) advanced non-small cell lung cancer patients with active epidermal growth factor receptor mutations receiving first-line gefitinib therapy: a single-institute retrospective study
Published date:
08/06/2020
Excerpt:
15 of 17 EGFR-mutant patients received EGFR-TKI therapy with gefitinib (n = 13) or osimertinib (n = 2). The OS tended to be longer in the TKI group than in the CT or BSC group (16.9 months vs. 7.2 months or 9.8 months, p = 0.059). Among the 34 super-elderly NSCLC patients with a PS score of 3-4, 7 with EGFR-mutant received gefitinib therapy and the remaining 27 received BSC alone. The OS tended to be longer in the TKI group than in the BSC group (4.6 months vs. 2.3 months, p = 0.060).
DOI:
10.1007/s00432-020-03344-1
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Making the case for EGFR TKI sequencing in EGFR mutation-positive NSCLC: a GioTag study US patient analysis
Published date:
08/06/2020
Excerpt:
To assess time-to-treatment failure (TTF) in US patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC)...In 129 patients at US centers, median TTF was 28.4 months (90% CI: 27.0-34.1). Median overall survival was 47.6 months (90% CI: 35.5-51.5)...Sequential afatinib-osimertinib in this US-treated population was associated with long median TTF and represents an effective, evidence-based treatment option for US patients with EGFR mutation-positive NSCLC not presenting with active brain metastases or de novo T790M.
DOI:
10.2217/fon-2020-0188
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Osimertinib improves overall survival in EGFR-mutated non-small cell lung cancer patients with leptomeningeal metastases regardless of T790M mutational status
Published date:
07/08/2020
Excerpt:
T790M mutation was detected in 88 of 197 patients tested, and a total of 110 patients were treated with osimertinib after LM. No significant difference in mOS was demonstrated according to T790M mutational status (10.1 months [95% CI 4.31-15.82] vs. 9.0 [6.81-11.21], P= 0.936)....Osimertinib is a promising treatment option for EGFR-mutated NSCLC with LM regardless of T790M mutational status.
DOI:
10.1016/j.jtho.2020.06.018
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
Osimertinib in previously EGFR-TKI treated non-small cell lung cancer (NSCLC) patients without T790M mutation: Real-world evidence.
Published date:
05/28/2020
Excerpt:
...first study to demonstrate that osimertinib can provide similar survival benefit in previously EGFR-TKI treated NSCLC patients without T790M mutation as those with T790M in real-world practice...
DOI:
10.1200/JCO.2020.38.15_suppl.e21631
Evidence Level:
Sensitive: C3 – Early Trials
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).
Published date:
05/16/2018
Excerpt:
Osimertinib showed highly active and durable in NSCLC patients harboring uncommon EGFR mutation with manageable safety profile, consistent with previous reports.
DOI:
10.1200/JCO.2018.36.15_suppl.9050
Evidence Level:
Sensitive: D – Preclinical
Title:
Identification and in silico structural insights of rare recurrent EGFR mutations as resistance mechanisms to osimertinib in EGFR-mutated lung cancer.
Published date:
05/13/2020
Excerpt:
...EGFR mutations, including C797S/G (22.1% vs. 0.5%), L718Q/V (6.2% vs. 0.3%), L792F/H (4.4% vs. 0.3%), were significantly more enriched in the osimertinib cohort. Our computational model has also successfully predicted their sensitivities to osimertinib: WT (-35.19 kcal/mol) > L792F (-34.10 kcal/mol) > L718Q (-30.33kcal/mol) > C797S (-28.02 kcal/mol), which are consistent with our previous in vitro validations....in silico structural model was proved to be powerful and robust in the prediction of osimertinib sensitivity of EGFR mutants.
DOI:
10.1200/JCO.2020.38.15_suppl.9531
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