Alunbrig (brigatinib) / Takeda - LARVOL DELTA

Clinical utility of liquid biopsy for non-small cell lung cancer patients with ALK fusion variants treated with brigatinib (ESMO 2024) - P2 | "Detection rate by ctDNA profiling is higher compared with RNA-based approaches and it is of prognostic significance."

Biopsy • Clinical • Liquid biopsy • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4 • TMB

Real-World Use of ALK Inhibitors in Advanced Non-Small Cell Lung Cancer: A Multicenter Study in Kazakhstan (IASLC-WCLC 2026) - "Methods : A retrospective, multicenter cohort study was conducted across oncology centers in Kazakhstan, including patients with ALK-positive non-small cell lung cancer (NSCLC) treated with alectinib, brigatinib, or lorlatinib in routine clinical practice. Mortality was numerically higher among patients with CNS metastases compared to those without ( 9.1% vs 4.7%; p=0.31 ), although this difference did not reach statistical significance.At the time of data cutoff, the majority of patients remained on treatment, and median progression-free survival (PFS) had not been reached . Conclusions : his large real-world multicenter cohort from Central Asia demonstrates a substantial burden of CNS metastases and frequent use of sequential ALK inhibitor therapy in ALK-positive NSCLC.Baseline CNS involvement appears to define a clinically more challenging subgroup, associated with a more intensive treatment trajectory and greater reliance on later-line therapies.These findings..."

Clinical • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Updated overall survival (OS) data from the phase II study of brigatinib in patients with ROS1-rearranged non-small cell lung cancer (NSCLC): Barossa study. (ESMO 2026) - No abstract available

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Real-World Clinical Outcomes, Healthcare Utilization, and Costs of ALK TKIs in Patients With ALK+ NSCLC: A Claims Analysis (IASLC-WCLC 2026) - "Patients were categorized by the TKI generation: first-generation (crizotinib) or second/third generation (ceritinib, alectinib, brigatinib, lorlatinib). The favorable 1-year OS rate of 97.8% and a manageable adverse event profile further support the real-world effectiveness and value of modern ALK TKIs. These findings underscore the importance of comprehensive payer-level cost-consequence analyses to characterize the full economic and clinical value of targeted therapies in ALK+ NSCLC."

Clinical • Clinical data • HEOR • Real-world • Real-world evidence • Febrile Neutropenia • Interstitial Lung Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • ALK

Sex Differences in Cardiovascular Outcomes Among Patients With Lung Cancer Treated With ALK Inhibitors: A Propensity Score-Matched Analysis (IASLC-WCLC 2026) - "Adult patients with lung cancer treated with ALK inhibitors (alectinib, crizotinib, ceritinib, brigatinib, or lorlatinib) were identified and stratified by sex (male vs female)...Baseline characteristics were well balanced, including age (~60 years), metastatic disease (~43%), and prior chemotherapy, including platinum chemotherapy (~14%) and pemetrexed (~11%)...Conclusions : In this large propensity score-matched real-world analysis, male patients receiving ALK inhibitors had higher risks of arrhythmias and mortality compared with female patients, with no differences in thromboembolic outcomes. These findings suggest sex-specific differences in cardiovascular toxicity associated with ALK-targeted therapy and support tailored risk stratification in patients with NSCLC."

Clinical • Atrial Fibrillation • Congestive Heart Failure • Heart Failure • Lung Cancer • Myocardial Infarction • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Venous Thromboembolism

Prophylactic peptide vaccine targeting resistance mutations in advanced ALK-positive lung cancer: Primary analysis from the ARCHER trial. (ASCO 2026) - P1/2 | "Patients continued their ALK TKI and received ALK-Vac, consisting of synthetic long peptides targeting seven common ALK resistance mutations (I1171T, I1171N, I1171S, L1196M, G1202R, D1203N, E1210K) plus poly-ICLC adjuvant...Concomitant TKIs included alectinib (7/15, 47%), lorlatinib (5/15, 33%), and brigatinib (3/15, 20%)... ALK-Vac was well-tolerated and induced vaccine-specific T cell responses in a minimal residual disease setting, demonstrating feasibility of prophylactic targeting of ALK resistance mutations as an adjunct to TKI therapy and supporting a broader immune-interception framework potentially applicable to other oncogene-driven NSCLC. Comprehensive cfDNA and immune-phenotyping analyses will be reported."

First-in-human • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • IFNG • KRAS

A Phase II Trial of Neoadjuvant Brigatinib in Resectable ALK-Positive Non-Small Cell Lung Cancer with Single-cell Resolution Mapping of the Immune Determinants of Pathologic Response (ESMO 2026) - No abstract available

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

ALKOVE-1: Efficacy and safety of neladalkib in patients with advanced ALK+ NSCLC. (ASCO 2026) - P1/2 | "c Pts with 1 prior 2nd generation ALK TKI (alectinib, n=44; brigatinib, n=2) ± chemo: ORR 48% (22/46) and DOR ≥ 12 m of 74% (95% CI: 48, 88). In this ALK TKI pre-treated data set, neladalkib demonstrated clinically meaningful activity, including in pts with CNS disease, ALK G1202R single or compound mutations, and prior lorlatinib. Encouraging preliminary activity was also observed in TKI-naïve pts. Neladalkib's safety profile was consistent with its ALK-selective, TRK-sparing design."

Clinical • Metastases • CNS Disorders • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK

Brigatinib Versus Alectinib in ALK-positive Non-small Cell Lung Cancer After Disease Progression on Crizotinib: Results of Phase 3 ALTA-3 Trial. (PubMed, J Thorac Oncol) - P3 | "Brigatinib was not superior to alectinib for PFS in crizotinib-pretreated ALK+ NSCLC. Safety was consistent with the well-established and unique profiles of each drug. The low proportion of patients with ctDNA-detectable ALK fusion may account for prolonged PFS with both drugs in ALTA-3."

Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Final Analysis of Brighstar: LCT With Brigatinib in Tyrosine Kinase Inhibitor-Naïve ALK-Rearranged Metastatic NSCLC (IASLC-WCLC 2025) - P1, P3 | "Individual patient data from a phase 3 trial of brigatinib vs crizotinib (ALTA-1L, NCT02737501) were retrospectively compared...One patient with grade 3 pneumonitis successfully transitioned to full-dose alectinib after resolution with corticosteroids...Conclusions : Brigatinib with LCT is safe in patients with ALK-rearranged advanced NSCLC and yielded promising results when compared to historical outcomes from brigatinib alone. Patients who received comprehensive LCT had superior outcomes, and baseline ctDNA status and radiological volumetric measurements may serve as prognostic biomarkers for treatment response."

Metastases • Anemia • Endocrine Disorders • Gastrointestinal Disorder • Hematological Disorders • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Pneumonia • Renal Disease • Solid Tumor • ALK

ALTA-3: A randomized trial of brigatinib (BRG) vs alectinib (ALC) in crizotinib (CRZ)-refractory advanced ALK+ NSCLC (ESMO Asia 2022) - P3 | "Conclusions At the IA, BIRC PFS was numerically similar between arms. No new safety findings were observed, with safety profiles consistent with known BRG and ALC profiles."

Clinical • Anemia • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

An Asian Multi-Centre, Real-World Study of Treatment Patterns and Outcomes in Asian Patients With Advanced ALK-rearranged NSCLC (IASLC-WCLC 2026) - "First line crizotinib, brigatinib, ceritinib, alectinib and lorlatinib were administered in 18%, 5%, 2%, 70%, and 5% of patients, with ORRs of 78%, 90%, 75%, 85% and 95%, respectively. Conclusions : In the largest multi-centre Asian RWD of advanced ALK+ NSCLC, ALK TKIs are effective, with a 5 year OS rate of 71%. Clinical outcomes from this study were largely within expectations of previously reported randomized trials."

Clinical • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK

Efficacy of Sequential ALK- and MET-TKI Combinations for Treating ALK-rearranged NSCLC With Acquired MET Amplification (IASLC-WCLC 2026) - "The patient initiated a combination of brigatinib and the ALK/ROS1/MET-TKI, crizotinib, with disease control for nine months...Based on these results, a combination of the ALK-TKI, alectinib, and more potent MET-TKI, capmatinib, was initiated...Nevertheless, this case, in which first low-level and then high-level MET amplification emerged as ALK-TKI-resistance, suggests that both amplification levels may be effectively targeted. Thus, sequential combinations of ALK- and MET-TKIs may provide meaningful clinical benefits in patients with ALK -rearranged NSCLC acquiring MET amplification at increasing levels."

Clinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Respiratory Diseases • Solid Tumor • ALK • EML4 • MET • ROS1 • TP53

CVD Risk in Advanced NSCLC With ALK TKI (IASLC-WCLC 2026) - "The ALK-TKI cohort included patients with advanced NSCLC who initiated ALK-targeted therapy, comprising those treated with first-generation crizotinib (n=1,717), second-generation alectinib or brigatinib (n=2,387), sequential first- to second-generation ALK-TKI (n=646), sequential second- to third-generation lorlatinib therapy (n=322), and sequential first-, second-, and third-generation therapy (n=197), for a total of 5,591 patients. Conclusions : In this nationwide real-world analysis, ALK-TKI treatment in advanced ALK-rearranged NSCLC was associated with a significantly increased risk of incident cardiovascular disease compared with surgically treated controls. Given the relatively favorable prognosis and prolonged treatment exposure in this population, longitudinal cardiovascular surveillance and proactive cardio-oncology management warrant consideration during ALK-TKI therapy."

Metastases • Atrial Fibrillation • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK

Real-world outcomes and treatment patterns in adults with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) on first-line (1L) brigatinib: Interim results (ESMO 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Longitudinal Tracking of ALK-Rearranged NSCLC From Plasma Using Circulating Tumor RNA and Circulating Tumor DNA. (PubMed, JTO Clin Res Rep) - P1 | "We retrospectively analyzed 86 plasma samples from 33 patients enrolled in the BRIGHTSTAR clinical trial assessing local consolidative therapy (LCT) and brigatinib in patients with stage IV or recurrent NSCLC and confirmed ALK rearrangement (NCT03707938) using a targeted next-generation sequencing assay that analyzes ctDNA to detect gene rearrangements and mutations in 80 genes and ctRNA to detect gene arrangements in 36 genes...Plasma cell-free DNA concentrations for patients with detectable ALK rearrangements at baseline were significantly higher than for those without detectable gene fusions (12.3 ng/mL versus 20.2 ng/mL, p = 0.0046). The inclusion of ctRNA in liquid biopsies increased detection of ALK rearrangements and detection at baseline was associated with significantly worse progression-free survival highlighting the added benefit of ctRNA."

Circulating tumor DNA • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Real-World Comparative Effectiveness of 1L Alectinib, Brigatinib, and Lorlatinib for ALK+ Ansclc (IASLC-WCLC 2026) - "Introduction : Clinical trials have demonstrated superior efficacy of next-generation Anaplastic Lymphoma Kinase (ALK) tyrosine kinase inhibitors (TKIs), alectinib, brigatinib, and lorlatinib, for first line (1L) treatment of ALK positive (ALK+) aNSCLC compared to the first-generation agent, crizotinib. The findings align with recent real-world comparisons of ALK TKIs. Additional studies with larger sample sizes and longer follow up are needed to substantiate these results."

Clinical • HEOR • Real-world • Real-world evidence • Non Small Cell Lung Cancer • Solid Tumor • ALK

Expanding therapeutic options for people with NF2-related schwannomatosis: Encouraging results with brigatinib. (PubMed, Neuro Oncol) - No abstract available

Journal • Brain Cancer • Solid Tumor

Prospective observational study of brigatinib after alectinib in ALK-positive, non-small cell lung cancer: Efficacy and biomarker analyses from cohort A of the WJOG11919L/ABRAID trial (ESMO 2025) - P=N/A | "Conclusions In this large prospective study of post-alectinib cases, brigatinib appeared to be effective regardless of the presence of ALK resistance mutations, including G1202R. Together with the safety profile consistent with previous reports, these findings suggest that brigatinib may be an appropriate treatment option in this setting."

Biomarker • Clinical • Observational data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • TP53

Phase II study of brigatinib in patients with TKI-naive ROS1-rearranged non-small cell lung cancer (NSCLC):Barossa study. (JSMO 2023) - No abstract available

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Treatment Sequences and Outcomes in Patients With ALK/ROS1 Advanced Non-Small Cell Lung Cancer: A Nationwide Cohort Study (IASLC-WCLC 2026) - "The most common first line treatments were alectinib (1347, 38.8%), crizotinib (735, 21.2%), brigatinib (268, 7.7%) and lorlatinib (139, 4.0%). Alectinib and Brigatinib show comparable overall survival outcomes. However, the limited evidence available for first-line lorlatinib precludes any consistent conclusion regarding its efficacy in this setting."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Real-World Outcomes of Polish Patients With ALK-Positive NSCLC Treated With Brigatinib: 1-Year Results (ENTIRETY Study) (IASLC-WCLC 2026) - P | "Most common AEs were abnormal laboratory investigations and general disorders/administration site conditions. Conclusions : Interim analysis results of ENTIRETY demonstrated sustained effectiveness and safety of first-line brigatinib in Polish patients with ALK+ NSCLC in real-world settings."

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK

Brigatinib in NF2-Related Schwannomatosis with Progressive Tumors. (PubMed, N Engl J Med) - P2 | "Brigatinib treatment resulted in radiographic responses in multiple tumor types and clinical benefit in a heavily pretreated cohort of patients with NF2-SWN. (Funded by the Children's Tumor Foundation and others; INTUITT-NF2 ClinicalTrials.gov number, NCT04374305.)."

Journal • Brain Cancer • CNS Tumor • Ependymoma • Genetic Disorders • Meningioma • Neurofibromatosis • Oncology • Pain • Solid Tumor • NF2

Patterns of Progression with Lorlatinib and Insights into Subsequent Anticancer Therapy Efficacy in Advanced ALK+ NSCLC (IASLC-WCLC 2024) - P3 | "Best Overall Response and Objective Response Rate on First Subsequent Anticancer Therapy Study treatment Lorlatinib Crizotinib First Subsequent Therapy Any ALK TKI (n=23) a Any non-ALK TKI (n=15) b Overall (n=38) Any ALK TKI (n=101) a Any non-ALK TKI (n=8) b Overall (n=109) Objective response rate (95% CI), % c 26.1 (10.2-48.4) 20.0 (4.3-48.1) 23.7 (11.4-40.2) 17.8 (10.9-26.7) 12.5 (0.3-52.7) 17.4 (10.8-25.9) Best overall response, n (%) Complete response 2 (9) 1 (7) 3 (8) 1 (1) 0 1 (1) Partial response 4 (17) 2 (13) 6 (16) 17 (17) 1 (13) 18 (17) Stable disease 1 (4) 3 (20) 4 (11) 23 (23) 0 23 (21) Progressive disease 6 (26) 3 (20) 9 (24) 10 (10) 2 (25) 12 (11) Unknown 3 (13) 5 (33) 8 (21) 9 (9) 4 (50) 13 (12) Not reported, therapy ongoing 7 (30) 1 (7) 8 (21) 41 (41) 1 (13) 42 (39) a Includes alectinib, brigatinib, ceritinib, crizotinib, and lorlatinib. b Includes chemotherapy ± anti-angiogenic, chemotherapy/immunotherapy,..."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

An Asian Multi-Centre, Real-World Study of Treatment Patterns and Outcomes in Asian Patients With Advanced ALK-rearranged NSCLC (IASLC-WCLC 2026) - "First line crizotinib, brigatinib, ceritinib, alectinib and lorlatinib were administered in 18%, 5%, 2%, 70%, and 5% of patients, with ORRs of 78%, 90%, 75%, 85% and 95%, respectively. Conclusions : In the largest multi-centre Asian RWD of advanced ALK+ NSCLC, ALK TKIs are effective, with a 5 year OS rate of 71%. Clinical outcomes from this study were largely within expectations of previously reported randomized trials."

Clinical • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK