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Association details:

Evidence:

Evidence Level:
Sensitive: A1 - Approval
Source:
Title:
Health Canada approves new indication for lung cancer treatment option ALUNBRIG
Published date:
03/17/2021
Excerpt:
Takeda Canada Inc. is pleased to announce that Health Canada has issued ALUNBRIG (brigatinib tablets) marketing authorization without conditions as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).
Evidence Level:
Sensitive: A1 - Approval
Title:
brigatinib (Alunbrig®) is accepted for use within NHSScotland
Published date:
12/04/2020
Excerpt:
brigatinib (Alunbrig®) is accepted for use within NHSScotland...as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
Evidence Level:
Sensitive: A1 - Approval
Published date:
11/22/2018
Excerpt:
Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor....Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALK positive advanced NSCLC previously treated with crizotinib.
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
04/28/2017
Excerpt:
ALUNBRIG is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Evidence Level:
Sensitive: A1 - Approval
Excerpt:
ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:
Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
Published date:
03/20/2019
Excerpt:
Brigatinib is recommended, within its marketing authorisation, for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
…the NCCN NSCLC Panel preference stratified the first-line therapy regimens and decided that brigatinib and ceritinib are "other recommended" options for patients with ALK-positive metastatic NSCLC; alectinib is the preferred first-line therapy option for ALK-positive metastatic NSCLC.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:
Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Excerpt:
Brigatinib is associated with longer PFS than crizotinib at the first interim analysis and showed activity against CNS disease in previously untreated patients with ALK-positive NSCLC…
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
Brigatinib: A Review in ALK-Inhibitor Naïve Advanced ALK-Positive NSCLC
Published date:
02/02/2021
Excerpt:
In a multinational, phase III study (ALTA-1L) in this patient population, brigatinib significantly improved median blinded independent review committee-assessed progression-free survival (PFS), the confirmed objective response (OR) rate and the confirmed intracranial OR rate compared with crizotinib.
DOI:
10.1007/s40265-020-01449-y
Evidence Level:
Sensitive: B - Late Trials
Title:
P84.08 - First-line Brigatinib in Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer: A Network Meta-Analysis
Published date:
01/12/2021
Excerpt:
...phase II or III randomized controlled trials (RCTs) in ALK inhibitor-naïve ALK-positive NSCLC patients...brigatinib significantly reduced the risk of disease progression or death....Brigatinib significantly prolonged PFS in ALK inhibitor-naïve patients with ALK-positive NSCLC...
Evidence Level:
Sensitive: B - Late Trials
Title:
Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial
Published date:
08/11/2020
Excerpt:
Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137...) With median follow-up of 24.9 months for brigatinib (150 PFS events), brigatinib showed consistent superiority in BIRC-assessed PFS versus crizotinib (hazard ratio [HR], 0.49 [95% CI, 0.35 to 0.68]; log-rank P < .0001; median, 24.0 v 11.0 months)...Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank P = .049)...Brigatinib represents a once-daily ALK inhibitor with superior efficacy, tolerability, and QoL over crizotinib, making it a promising first-line treatment of ALK-positive NSCLC.
DOI:
10.1200/JCO.20.00505
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
Population pharmacokinetic (PK) and exposure-response analyses from the pivotal ALTA-1L study: Model-based analyses supporting the brigatinib dose in patients with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC).
Published date:
05/28/2020
Excerpt:
...efficacy benefit was consistent across the range of exposures achieved with the 180 mg dosing regimen including after dose modifications....results support a favorable benefit/risk profile of the proposed 180 mg qd brigatinib dose (with a 7-day lead-in at 90 mg) for the front-line treatment of patients with ALK+ NSCLC.
DOI:
10.1200/JCO.2020.38.15_suppl.e21725
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:
Phase III ALTA-1L Trial Shows Promise for Patients with Non-Small Cell Lung Cancer
Excerpt:
275 patients were randomized to receive either 180 mg of brigatinib once daily, with a 7-day lead in at 90 mg once daily, or 250 mg of crizotinib twice daily….Results indicated that after more than 2 years of follow-up, brigatinib reduced the risk of disease progression or death by 76% (HR = 0.24; 95% CI, 0.12-0.45) in newly diagnosed patients whose disease had spread to the brain at time of enrollment. There was also a 57% reduction in risk of disease progression or death in all patients (HR = 0.43; 95% CI, 0.31-0.61)....The ongoing phase III ALTA-1L trial of brigatinib (Alunbrig) versus crizotinib (Xalkori) suggested that brigatinib reduced the risk of disease progression or death in adults with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Excerpt:
...With ALK-positive advanced or metastatic NSCLC....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients
Excerpt:
...a positive result from the Vysis® ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit; or 2....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors
Excerpt:
...- With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping
Excerpt:
...Documentation of ALK rearrangement by a positive result of any ALK assay approved in Germany [i.e. positivity for at least one of the three: immunohistochemistry (IHC), NGS, fluorescence in situ hybridisation (FISH)] must be available at baseline....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:
A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
Excerpt:
...Have documented ALK rearrangement by a positive result from the Vysis® ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit; or 2....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer
Excerpt:
...- Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit or the Ventana ALK (D5F3) CDx Assay or Foundation Medicine's FoundationOne CDx....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:
Brigatinib in the first-line treatment of ALK+ metastatic NSCLC: safety and efficacy
Published date:
04/27/2021
Excerpt:
Brigatinib showed a superior efficacy in terms of ORR (71% vs 60%) and of intracranial response rate (78% vs 29%) compared to Crizotinib....ALTA-1L trial showed high efficacy and good tolerability of Brigatinib as upfront treatment in ALK+ metastatic NSCLC.
DOI:
https://doi.org/10.1080/14737140.2021.1923485
Evidence Level:
Sensitive: C3 – Early Trials
Title:
P75.01 - Activity of Brigatinib in Alectinib-Resistant ALK-Positive NSCLC According to ALK Plasma Mutation Status From J-ALTA Trial
Published date:
01/12/2021
Excerpt:
Of the 72 ALK+ NSCLC patients enrolled...Brigatinib demonstrated meaningful activity in ALK TKI-resistant patients regardless of the presence of secondary ALK mutations and EML4-ALK fusion status in plasma.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Brigatinib and lorlatinib: their effect on ALK inhibitors in NSCLC focusing on resistant mutations and central nervous system metastases
Published date:
11/05/2020
Excerpt:
Brigatinib has shown promising antitumour activity, including substantial activity against central nervous system metastases, in crizotinib-treated (ALTA trial) patients and crizotinib-naïve (ALTA-1L trial) patients with anaplastic lymphoma kinase-positive non-small cell lung carcinoma. In addition, brigatinib improved progression-free survival compared with crizotinib in anaplastic lymphoma kinase inhibitor-naïve patients with anaplastic lymphoma kinase-positive non-small cell lung carcinoma.
DOI:
10.1093/jjco/hyaa192
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Preliminary clinical and molecular analysis results from a single arm phase 2 trial of brigatinib in patients with disease progression after next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors in advanced ALK + non-small cell lung cancer
Published date:
10/08/2020
Excerpt:
The objective response rate was 40% (95% confidence intervals (CI): 19% to 62%), and duration of response was 5.3 months (95% CI: 3.6 to non-evaluable). With follow-up of 22 months, the median progression-free survival (PFS) was 7.0 months (95% CI: 4.6 to 10.1)....Brigatinib has activity in ALK+ NSCLC following prior next generation ALK TKIs.
DOI:
10.1016/j.jtho.2020.09.018
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Brigatinib in ALK-positive non-small cell lung cancer: real-world data in the Latin American population (Bri-world extend CLICaP)
Published date:
09/28/2020
Excerpt:
From January 2018 to March 2020, 46 patients with advanced ALK-positive NSCLC received brigatinib as second or further line of therapy in Mexico and Colombia….At a median follow-up of 9.3 months, the median PFS was 15.2 months (95% CI: 11.6-18.8), and TTD was 18.46 months (95% CI: 9.54-27.38). The estimated overall survival at 12 months was 80%.
DOI:
10.2217/fon-2020-0747
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Exploratory Analysis of Brigatinib Activity in Patients With Anaplastic Lymphoma Kinase-Positive Non–Small-Cell Lung Cancer and Brain Metastases in Two Clinical Trials
Published date:
05/16/2018
Excerpt:
Brigatinib yielded substantial intracranial responses and durable iPFS in ALK-positive, crizotinib-treated NSCLC, with highest iPFS in patients receiving 180 mg once daily (with lead-in).
DOI:
10.1200/JCO.2017.77.5841
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer
Excerpt:
A total of 275 patients underwent randomization; 137 were assigned to brigatinib and 138 to crizotinib….The rate of progression-free survival was higher with brigatinib than with crizotinib (estimated 12-month progression-free survival, 67% [95% confidence interval {CI}, 56 to 75] vs. 43% [95% CI, 32 to 53]....Among patients with ALK-positive NSCLC who had not previously received an ALK inhibitor, progression-free survival was significantly longer among patients who received brigatinib than among those who received crizotinib.
DOI:
10.1056/NEJMoa1810171
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Brigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial
Excerpt:
We evaluated two regimens of brigatinib, an investigational next-generation ALK inhibitor, in crizotinib-refractory ALK-positive NSCLC...With 8.0-month median follow-up, investigator-assessed confirmed ORR was 45% (97.5% CI, 34% to 56%) in arm A and 54% (97.5% CI, 43% to 65%) in arm B. Investigator-assessed median progression-free survival was 9.2 months (95% CI, 7.4 to 15.6) and 12.9 months (95% CI, 11.1 to not reached) in arms A and B, respectively.
DOI:
10.1200/JCO.2016.71.5904
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