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Association details:
| Biomarker: | ALK rearrangement |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Alunbrig (brigatinib) (EGFR inhibitor, ALK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Therapy for Stage IV Non–Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline
Published date:
07/11/2022
Excerpt:
For patients with an anaplastic lymphoma kinase rearrangement, a performance status (PS) of 0-2, and previously untreated NSCLC, clinicians should offer…brigatinib…
DOI:
10.1200/JCO.22.00824
Source:
Published date:
09/15/2020
Excerpt:
The NCCN Panel preference stratified first-line therapy with brigatinib, ceritinib, or crizotinib for patients with ALK-rearrangement-positive metastatic NSCLC.
Non-Small Cell Lung Cancer….ALK REARRANGEMENT POSITIVE….SUBSEQUENT THERAPY...Continue alectinib or brigatinib or ceritinib or lorlatinib
Source:
Excerpt:
First-line treatment of ALK-rearranged NSCLC…In patients with CNS involvement, front-line use of ALK TKIs is effective, and alectinib [III, A], brigatinib [III, B] or ceritinib [IV, B] are recommended.
Source:
Title:
Advancing Brigatinib Properties in anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC) patients by deep phenotyping
Excerpt:
...Histologically confirmed, locally advanced (stage III) and not suitable for curative treatment, i.e. R0 operation or definitive chemo-/radiation, or metastatic (stage IV) ALK+ NSCLCNOTE: 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:
Source:
Title:
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
Excerpt:
...Must have documented ALK rearrangement....
Trial ID:
More C2 evidence
Source:
Title:
Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)
Excerpt:
...If ALK rearrangement diagnostic is performed using IHC and the result is + or 2+, a confirmation with a second method performed locally (DNA-based or RNA-based next generation sequencing (NGS) assay, nCounter Nanostring assay or ALK FISH performed) is required....
Trial ID:
Source:
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:
Source:
Title:
Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients
Excerpt:
...ALK rearrangement by one of the following methods:...
Trial ID:
Source:
Title:
A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)
Excerpt:
...Participants with ALK gene rearrangement confirmed by local hospital medical records....
Trial ID:
Source:
Title:
A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
Excerpt:
...Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test® approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non-FDA-approved local lab tests) and have provided tumor sample to the central laboratory....
Trial ID:
Source:
Title:
Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)
Excerpt:
...Have documentation of ALK rearrangement that meets following criteria....
Source:
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:
Source:
Title:
Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors
Excerpt:
...Locally advanced or metastatic NSCLC that has been cytologically or histologically confirmed ALK rearrangement based on FDA approved test (e.g....
Source:
Title:
An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer
Excerpt:
...Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is determined to have an ALK-rearrangement detected according to local standard procedure....
Trial ID:
Source:
Title:
Utility of analysis in blood of the evolution of the drug brigatinib for patients with lung cancer with ALK mutations Utilidad del análisis en sangre de la evolución del fármaco brigatinib para pacientes con cáncer de pulmón con mutaciones ALK
Excerpt:
...Patients who have documented locally ALK rearrangement5. ...
Trial ID:
Source:
Title:
Study of safety and efficacy of combination brigatinib and carboplatin-pemetrexed therapy or brigatinib monotherapy as first treatment in patients with advanced ALK-positive lung cancer
Excerpt:
...If ALK rearrangement diagnostic is performed using IHC and the result is + or 2+, a confirmation with a second method performed locally (DNA-based or RNA-based next generation sequencing (NGS) assay, nCounter Nanostring assay or ALK FISH performed) is required.4. ...
Trial ID:
Source:
Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)
Excerpt:
...Expansion cohort 1: Non-small cell lung cancer (NSCLC) participants whose tumors exhibit anaplastic lymphoma kinase (ALK) rearrangements and who have...
Trial ID:
Source:
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:
Source:
Title:
A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Preoperative Brigatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Fusions.
Excerpt:
...Documented ALK rearrangement (VENTANA ALK (D5F3) CDx Assay or appropriate diagnostic method) 6....
Trial ID:
Less C2 evidence
Source:
Title:
1371P - First-line alectinib vs. brigatinib in advanced metastatic NSCLC with ALK rearrangement: Real-world data
Published date:
10/16/2023
Excerpt:
The ORR was 91.9% with alectinib and 92.2% for brigatinib (p-value: 0.54, 95% CI: 0.35–7.30); the intracranial ORR rates were 94.6% and 100%, respectively….Alectinib and brigatinib had similar clinical benefits when used as the first-line treatment of NSCLC patients with ALK rearrangement in the real world.
Source:
Title:
BRIGHTSTAR Local Consolidative Therapy with Brigatinib in Tyrosine Kinase Inhibitor-Naïve ALK-Rearranged Metastatic NSCLC
Published date:
08/08/2023
Excerpt:
Brigatinib with LCT is safe in patients with ALK-rearranged advanced NSCLC and yielded promising outcomes when compared to historical outcomes from brigatinib alone. Lower post-induction volume and complete LCT, but not number of metastases at baseline (oligo vs poly) were associated with increased benefit for LCT.
Trial ID:
Source:
Title:
First-Line Alectinib vs. Brigatinib in Advanced NSCLC with ALK Rearrangement: Real-World Data
Published date:
07/14/2023
Excerpt:
At the data cutoff point, the median follow-up duration was 16.5 months (95% CI; 14.7-18.3) in the brigatinib group and 27.5 months (95% CI; 24.6-30.4) in the alectinib group. The ORR was 92.5% with alectinib and 93.8% for brigatinib. The intracranial ORR rates were 92.7% (38/41) and 100% (10/10), respectively....Alectinib and brigatinib had similar clinical benefits when used as the first-line treatment of NSCLC patients with ALK rearrangement in the real world.
DOI:
10.4143/crt.2023.461
Source:
Title:
Targeted therapy for advanced anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer
Published date:
01/07/2022
Excerpt:
We included RCTs comparing ALK inhibitors with cytotoxic chemotherapy or another ALK inhibitor in individuals with incurable locally advanced or metastatic pathologically confirmed ALK‐rearranged NSCLC...five studies compared a next‐generation ALK inhibitor (alectinib, brigatinib, and lorlatinib) to crizotinib....Next‐generation ALK inhibitors resulted in a large increase in PFS (HR 0.39, 95% CI 0.33 to 0.46, 5 RCTs, 1263 participants, high‐certainty evidence), particularly in participants with baseline brain metastases….Next‐generation ALK inhibitors likely increase OS (HR 0.71, 95% CI 0.56 to 0.90, 5 RCTs, 1263 participants, moderate‐certainty evidence) and slightly increase ORR (RR 1.18, 95% CI 1.10 to 1.25, 5 RCTs, 1229 participants, moderate‐certainty evidence) including a response in measurable brain metastases (RR 2.45, 95% CI 1.7 to 3.54, 4 RCTs, 138 participants) when compared to crizotinib.
DOI:
10.1002/14651858.CD013453.pub2
Source:
Title:
Comparative efficacy and safety of first-line treatments for advanced non-small cell lung cancer with ALK-rearranged: a meta-analysis of clinical trials
Published date:
11/26/2021
Excerpt:
Here, we indirectly compared the efficacy and safety of first-line systemic therapeutic options used for the treatment of ALK-rearranged NSCLC….Our analysis showed that alectinib (300 mg and 600 mg), brigatinib, lorlatinib and ensartinib yielded the most favorable PFS....According to Bayesian ranking profiles, lorlatinib, alectinib 600 mg and alectinib 300 mg had the best PFS (63.7%), OS (35.9%) and ORR (37%), respectively.
DOI:
10.1186/s12885-021-08977-0
Source:
Title:
Outcomes of first, second, and third-generation anaplastic lymphoma kinase (ALK) inhibitors in non-small cell lung cancer brain metastases (NSCLCBM).
Published date:
05/19/2021
Excerpt:
NSCLCBM patients between 2010 and 2019 were evaluated....16 ALK positive patients received first-generation ALK inhibitor (crizotinib)...17 patients received second-generation (alectinib, ceritinib, brigatinib) and third-generation ALK inhibitors (lorlatinib)...The 5-year OS rate was 49% (95% confidence interval (CI) = 24%, 71%) for first-generation ALK inhibitors and 76% (95% CI = 40%, 92%) for second and third-generation ALK inhibitors (p-value (p) = 0.019).
DOI:
10.1200/JCO.2021.39.15_suppl.2034
Source:
Title:
Brigatinib in Japanese Patients With ALK–Positive Non–Small Cell Lung Cancer Previously Treated With Alectinib and Other Tyrosine Kinase Inhibitors: Outcomes of the Phase 2 J-ALTA Trial
Published date:
11/25/2020
Excerpt:
Disease control rate was 79% (95% CI, 64%-89%). Median IRC-assessed progression-free survival was 7.3 months (95% CI, 3.7-9.3)....Brigatinib showed clinically meaningful efficacy in Japanese patients with ALK+ NSCLC refractory to alectinib (with or without prior crizotinib).
DOI:
10.1016/j.jtho.2020.11.004
Source:
Title:
BRIGHTSTAR: A pilot trial of local consolidative therapy (LCT) with brigatinib in tyrosine kinase inhibitor (TKI)-naïve ALK-rearranged advanced NSCLC.
Published date:
05/13/2020
Excerpt:
Brigatinib with LCT is safe and feasible in patients with ALK-rearranged advanced NSCLC irrespective of number of metastatic sites.
DOI:
10.1200/JCO.2020.38.15_suppl.9624
Source:
Title:
Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial
Excerpt:
Between Sept 20, 2011, and July 8, 2014, we enrolled 137 patients (79 [58%] with ALK-rearranged NSCLC), all of whom were treated...four (100% [95% CI 40-100]) of four patients in cohort 1 had an objective response, 31 (74% [58-86]) of 42 did in cohort 2, none (of one) did in cohort 3, three (17% [4-41]) of 18 did in cohort 4, and five (83% [36-100]) of six did in cohort 5. 51 (72% [60-82]) of 71 patients with ALK-rearranged NSCLC with previous crizotinib treatment had an objective response (44 [62% (50-73)] had a confirmed objective response). All eight crizotinib-naive patients with ALK-rearranged NSCLC had a confirmed objective response (100% [63-100]). Three (50% [95% CI 12-88]) of six patients in cohort 5 had an intracranial response.
DOI:
10.1016/S1470-2045(16)30392-8
Trial ID:
