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Association details:
| Biomarker: | EGFR exon 19 deletion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Lazcluze (lazertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis
Published date:
10/22/2023
Excerpt:
LASER301 (ClinicalTrials.gov identifier: NCT04248829) is a randomized, double-blind, multinational phase 3 study that evaluated the efficacy and safety of lazertinib among patients with EGFR-mutated (exon 19 deletion or L858R mutation) locally advanced or metastatic NSCLC who had not previously received any line of therapy for NSCLC....for patients with baseline CNS metastases in the LASER301 study, lazertinib significantly improved iPFS versus gefitinib, with more durable responses and a tolerable safety profile, suggesting that lazertinib has the potential to improve CNS outcomes in patients with EGFR-mutated NSCLC.
DOI:
https://doi.org/10.1016/j.jtho.2023.08.017
Trial ID:
Source:
Title:
Lazertinib Versus Gefitinib Tyrosine Kinase Inhibitors in Treatment-Naíve Patients With EGFR-Mutated Advanced NSCLC: Analysis of the Asian Subpopulation in LASER301
Published date:
09/11/2023
Excerpt:
The phase 3 LASER301 study evaluated lazertinib efficacy and safety in treatment-naive patients with EGFR-mutated (exon 19 deletion or L858R) locally advanced or metastatic NSCLC....Between February 13, 2020, and July 29, 2022, among 258 patients of Asian descent, the median progression-free survival was significantly longer with lazertinib than gefitinib (20.6 versus 9.7 mo; hazard ratio: 0.46; 95% confidence interval [CI]: 0.34–0.63, p < 0.001), and the benefit was consistent across predefined subgroups (exon 19 deletion, L858R, baseline central nervous system metastases).
DOI:
https://doi.org/10.1016/j.jtho.2023.06.016
Trial ID:
Source:
Title:
Lazertinib vs Gefitinib in Treatment-Naïve Patients with EGFR-mutated NSCLC: LASER301 Asian Subpopulation Analysis
Published date:
08/08/2023
Excerpt:
LASER301, a randomized, double-blind, multinational phase 3 study, evaluated efficacy and safety of lazertinib in treatment-naïve patients with EGFR-mutated (exon 19 deletion [Ex19del]/L858R) locally advanced or metastatic NSCLC….the median PFS was significantly longer with lazertinib than gefitinib (20.6 vs 9.7 months; HR, 0.46; 95% confidence interval [CI]: 0.34-0.63; P<0.001). PFS benefit of lazertinib versus gefitinib among Asian patients was consistent across predefined subgroups (Ex19del mutations: 20.8 vs 12.3 months; HR, 0.47; 95% CI: 0.31-0.71; P<0.001; L858R: 16.7 vs 9.6 months; HR, 0.44; 95% CI: 0.28-0.71; P=0.002; CNS metastases at study entry: 20.7 vs 9.5 months; HR, 0.33; 95% Cl: 0.18-0.58; P<0.001)....Lazertinib demonstrated better efficacy than gefitinib in Asian patients, with a tolerable safety profile.
Trial ID:
Source:
Title:
Lazertinib Versus Gefitinib as First-line Treatment in Patients With EGFR-mutated Advanced Non-Small Cell Lung Cancer (NSCLC): Results From LASER301
Published date:
06/28/2023
Excerpt:
This global, phase 3 study (LASER301) compared lazertinib versus gefitinib in treatment-naïve patients with EGFR-mutated (exon 19 deletion [ex19del]/L858R) locally advanced or metastatic non-small cell lung cancer (NSCLC)….Lazertinib demonstrated significant efficacy improvement compared with gefitinib in the first-line treatment of EGFR-mutated advanced NSCLC, with a manageable safety profile.
DOI:
10.1200/JCO.23.00515
Trial ID:
Source:
Title:
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
Excerpt:
...- Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)...
Trial ID:
Source:
Title:
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
Excerpt:
...- At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations...
More C2 evidence
Source:
Title:
A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer. Estudio en fase II abierto y de cohortes paralelas de amivantamab subcutáneo con diversas pautas posológicas en pacientes con tumores sólidos avanzados o metastásicos, incluido el cáncer de pulmón no microcítico con mutaciones en el gen EGFR.
Excerpt:
...Participant must have histologically or cytologically confirmed, locally advanced or metastatic, NSCLC, characterized at the time of locally advanced or metastatic disease diagnosis.Additional Cohort specific disease requirements include:Cohorts 1 and 3: EGFR Exon19del or L858R mutationCohort 2: EGFR Exon 20ins mutationEGFR Exon19del or Exon 21 L858R mutation (Cohort 1 and 3) or EGFR Exon 20 insertion mutation (Cohort 2) must have been identified as determined by an FDA-approved or other validated test of either ctDNA or tumor tissue in a CLIA certified laboratory (sites in the US) or an accredited local laboratory (sites outside of the US). ...
Trial ID:
Source:
Title:
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
Excerpt:
...Presence of the sensitising EGFR-mutation (exon 19 deletion and/or L858R) detected by an accredited laboratory....
Trial ID:
Source:
Title:
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Excerpt:
...EGFR gene mutations in the test on bronchoalveolar lavage fluid:...
Trial ID:
Source:
Title:
Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations
Excerpt:
...Confirmed uncommon EGFR mutations (e.g....
Trial ID:
Source:
Title:
The Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
Excerpt:
...Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation....
Trial ID:
Less C2 evidence
Source:
Title:
EP08.02-025 - Lazertinib as a Frontline Treatment in Patients with EGFR Mutant Advanced Non-Small Cell Lung Cancer: Results from the Phase I/II Trial
Published date:
07/12/2022
Excerpt:
In 35 patients out of 43, common EGFR mutation of either Exon19Del (n=23) or L858R (n=12) was centrally confirmed. In this group, the confirmed ORR as per ICR was 77.1% (95% CI, 63.2 to 91.1), of which 6 patients (17.1%) had CR and 21 patients (60.0%) had PR. The DCR by ICR was 94.3% (95% CI, 86.6 to 100.0). The median DoR and PFS by ICR were 23.5 months (95% CI, 11.0 to NR) and 24.9 months (95% CI, 13.6 to NR) respectively....Lazertinib 240 mg demonstrated a median progression-free survival exceeding 2 years, promising and durable anti-tumor activity, including complete responses, and a favorable safety profile in this frontline cohort.
Trial ID:
