Alecensa (alectinib) / Roche - LARVOL DELTA

Alectinib in combination with bevacizumab as first-line treatment in ALK-rearranged non-small cell lung cancer (ALEK-B): a single-arm, phase 2 trial. (PubMed, Nat Commun) - P2 | "QoL significantly improved from baseline at 12 months and was maintained through 36 months. These findings support the efficacy and safety of alectinib plus bevacizumab and justify further investigation in ALK-rearranged NSCLC."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • ALK

Phase 3 Trial of Crizotinib vs Observation for Surgically Resected Early-Stage ALK+ NSCLC (IASLC-WCLC 2025) - "Results : Between August 2014 and May 2024, 166 patients were enrolled in the study (of a planned sample size of 168), with enrollment stopped at the time of FDA approval of adjuvant alectinib for resected ALK+ NSCLC. Median duration of crizotinib therapy was 13.5 (IQR 3.4-23.9) months; 19 patients (22%) had crizotinib dose reductions and 21 (25%) discontinued crizotinib due to toxicities. Conclusions : Adjuvant crizotinib does not prolong DFS in resected ALK+ NSCLC."

P3 data • Lung Cancer • Non Small Cell Lung 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

NAUTIKA1: Primary Analysis of Neoadjuvant Alectinib in Resectable Stage IB-IIIB ALK+ NSCLC (IASLC-WCLC 2026) - P2 | "Conclusions : This primary analysis from NAUTIKA1 demonstrated clinically meaningful MPR, pCR and objective response rates with no new safety signals. Neoadjuvant alectinib is a promising treatment that can be added as a perioperative approach for resectable, stage IB-IIIB ALK + NSCLC."

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

Crizotinib versus observation or placebo for surgically resected early-stage ALK-positive non-small-cell lung cancer (Eastern Cooperative Oncology Group-American College of Radiology Imaging Network E4512): a phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "Adjuvant crizotinib does not prolong DFS in patients with surgically resected ALK-positive NSCLC. These findings suggest that crizotinib should not be recommended as an adjuvant therapy for patients with resected ALK-positive NSCLC."

Journal • P3 data • Cardiovascular • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Pulmonary Disease • Solid Tumor • ALK

Updated results from the phase III ALINA study of adjuvant alectinib vs chemotherapy (chemo) in patients (pts) with early-stage ALK+ non-small cell lung cancer (NSCLC) (ESMO 2025) - P3 | "AE, adverse event; NE, not evaluable. Conclusions After ≥3 years of follow-up, alectinib continued to show a clinically meaningful DFS benefit and safety data remain consistent with the well-established, manageable profile, reinforcing adjuvant alectinib as standard of care for pts with resected ALK + NSCLC."

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

Neurologic Burden, Treatment Patterns, and Outcomes in NSCLC Presentingwithcns Metastases: A Retrospective Cohort From Colombia (IASLC-WCLC 2026) - "CNS-penetrant tyrosine kinase inhibitors (TKIs) were defined as osimertinib, alectinib, or lorlatinib...Forty-four patients received systemic therapy, 39 received CNS-directed radiotherapy, and 20 received CNS-penetrant TKIs; 5 received bevacizumab, including 2 in combination with CNS-penetrant TKIs...CNS-penetrant TKIs showed a consistent signal of clinical benefit across survival outcomes. These findings underscore the need for rapid neurologic evaluation, coordinated multidisciplinary care, and timely access to effective CNS-active therapies."

Retrospective data • CNS Disorders • Cognitive Disorders • Epilepsy • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR

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

Clinical Outcomes of Neoadjuvant Therapy in Early-Stage NSCLC Harboring ALK, ROS1, or RET Fusions (IASLC-WCLC 2026) - "Currently, PD-L1 expression is the only validated biomarker guiding neoadjuvant treatment; however, oncogenic drivers like EGFR and ALK are routinely used to decide perioperative strategies, avoiding immunotherapy in these subgroups and prioritizing adjuvant treatment with TKIs such as osimertinib and alectinib. Conclusions : While neoadjuvant therapy type did not influence EFS, the use of adjuvant TKI was associated with improved EFS. These findings support the potential role of TKI in the perioperative management of fusion-positive NSCLC."

Clinical • Clinical data • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • PD-L1 • RET • ROS1

Adjuvant Treatment of Postoperative ALK-positiveNSCLCwith Ensartinib Guided by MRD: A Single-Arm, Multicenter Study (Ensapilot) (IASLC-WCLC 2026) - P2, P3 | "While alectinib is currently the only approved adjuvant therapy for patients with completely resected ALK-positive NSCLC (stage IB [tumor ≥4 cm] to IIIA per the 7th edition of the AJCC staging system). Statistical analysis will utilize the Kaplan-Meier method to estimate median DFS and OS with 95% confidence intervals (CIs); time-to-event rates at specified time points will also be reported with 95% CIs. Patient enrollment commenced in March 2025 and is currently ongoing."

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

Efficacy of alectinib for ALK-positive NSCLC according to tumor burden and body mass index: A pooled analysis of the randomized phase III trials ALEX and J-ALEX. (PubMed, Eur J Cancer) - P3 | "Tumor burden was prognostic and predictive in ALK-positive NSCLC. Treatment intensification may benefit patients with high tumor burden."

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

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

Lorlatinib Versus Pemetrexed-Based Chemotherapy in Patients With ALK-rearranged NSCLC Previously Treated With Alectinib. (PubMed, JTO Clin Res Rep) - "In patients without CNS metastasis at baseline, the cumulative incidence rate of CNS progression was lower over time in the LOR group compared with the PEM group (p = 0.045), whereas in patients with CNS metastasis at baseline, there were no significant differences in cumulative incidence rate of CNS progression between both groups (p = 0.43). Clinical outcomes of PEM and LOR after failure of alectinib were similar in patients with ALK-positive NSCLC."

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

Neoadjuvant lorlatinib in stage III NSCLC harboring ALK fusion: A phase 2 multicenter study (LORIN). (ASCO 2026) - P2 | "Funded by National Science Foundation of China, National Science Foundation of China Clinical Trial Registration Number: NCT05740943 Background: While adjuvant alectinib has established itself as the new standard for resected anaplastic lymphoma kinase (ALK) fusion non-small cell lung cancer (NSCLC), there is limited data on neoadjuvant treatment for locally advanced ALK fusion NSCLC. Neoadjuvant lorlatinib unveiled overwhelming pathological response and could lead to high conversion surgery for unresectable stage III disease. Further large-scale prospective trial was warranted to testified such treatment modality."

Clinical • P2 data • Dyslipidemia • Hypertriglyceridemia • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Solid Tumor • ALK

Neladalkib (NVL-655), a highly selective anaplastic lymphoma kinase (ALK) inhibitor, compared to alectinib in first-line treatment of patients with ALK-positive advanced non-small cell lung cancer: The phase 3 ALKAZAR study. (ASCO 2025) - P3 | "Additional analyses will be conducted to investigate candidate biomarkers and molecular mechanisms of response and resistance to neladalkib and alectinib. The study is open to accrual."

Clinical • Metastases • P3 data • CNS Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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

Final overall survival (OS) and safety analysis of the phase III ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) (ESMO 2025) - P3 | "Safety data were in line with the known safety profile of alectinib. These data continue to support 1L alectinib as a standard of care in pts with advanced ALK + NSCLC."

Clinical • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • ALK

A Phase II Trial of Stereotactic Body Radiotherapy (SBRT) in Patients with Stage IV Oncogene-Driven Non-Small Cell Lung Cancer (NSCLC) (ASTRO 2024) - "Most had EGFR driver mutations (n=22, 54.5% on osimertinib), followed by ALK (n=4, on alectinib or lorlatinib), and ROS1 fusions (n=1, on crizotinib). Consolidation SBRT to predominantly the primary lung site in pts with oncogene-driven metastatic NSCLC was not associated with decrease in frequency of DF which constituted 50% of first failures at 1 year. The lack of reduction in DF suggests that SBRT to the primary lung site only is insufficient. Consideration should be given to consolidation SBRT to not only the primary site but also additional original sites of metastasis."

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

A Single-Arm Confirmatory Trial Evaluating Adjuvant Alectinib 300 mg Twice Daily in Japanese Patients With ALK+ Resected NSCLC: J-ALINA (IASLC-WCLC 2026) - "Patient enrollment is scheduled to begin in April 2026. $$graphic_C841D770-F45E-4FD8-805A-89525DCACF13$$"

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

Minimal residual disease guides postoperative therapy in a patient with ALK-rearranged adenocarcinoma: a case report. (PubMed, Front Oncol) - "We present a case of a 43-year-old female patient with stage IVA ALK-rearranged NSCLC who initially responded to six months of Alectinib targeted therapy, underwent consolidative surgery with postoperative pathology confirming complete response in the resected primary tumor and lymph nodes, and continued two years of maintenance therapy...Although MRD monitoring represents an important advancement in NSCLC management, our findings emphasize the need for additional research to validate its clinical applications, particularly in guiding treatment decisions and predicting disease recurrence. The results suggest that larger prospective studies are required to establish evidence-based protocols for MRD monitoring in NSCLC patients."

Journal • Minimal residual disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

ALINA: Efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC) (ESMO 2023) - P3 | "Table: LBA2 Stage II–IIIA ITT (Stage IB–IIIA) Efficacy Alectinib (n=116) CT (n=115) Alectinib (n=130) CT (n=127) DFS events, n (%) 14 (12.1) 45 (39.1) 15 (11.5) 50 (39.4) Median DFS, months (95% CI) NE 44.4 (27.8–NE) NE 41.3 (28.5–NE) Stratified HR (95% CI) 0.24 (0.13–0.45) 0.24 (0.13–0.43) p value <0.0001 <0.0001 24-month DFS rate, % 93.8 63.0 93.6 63.7 36-month DFS rate, % 88.3 53.3 88.7 54.0 Safety population Safety Alectinib(n=128) CT (n=120) Grade 3–4 AEs, n (%)* 38 (29.7) 37 (30.8) Serious AEs, n (%) 17 (13.3) 10 (8.3) Serious treatment-related AEs, n (%) 2 (1.6) 8 (6.7) AEs leading to treatment withdrawal, n (%) 7 (5.5) 15 (12.5) AEs, adverse events; NE, not estimable. ∗No Grade 5 AEs in either treatment arm"

Clinical • Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Health-related quality of life (HRQoL) results for adjuvant alectinib vs chemotherapy in patients with resected ALK+ non-small cell lung cancer (NSCLC): Data from ALINA. (ASCO 2024) - P3 | "Alectinib demonstrated an improvement in most domains of HRQoL by Week 12, followed by maintenance of HRQoL on all 8 domains, MCS and PCS to Week 96. With chemotherapy, HRQoL was low during treatment, but improved in the post-chemotherapy period. Together with the DFS benefit seen in ALINA, these data support alectinib as an important new adjuvant treatment for patients with resected ALK+ NSCLC."

Clinical • HEOR • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor

Comparative Disproportionality Analysis of Metastatic and Neoplastic Progression Signals Associated With Crizotinib Versus Alectinib in the EudraVigilance Database (ESMO 2026) - No abstract available

Metastases • Oncology

How to manage radioiodine-refractory thyroid cancer in the era of precision medicine. (PubMed, Drugs Context) - "Three multi-kinase inhibitors have been approved for this indication: lenvatinib and sorafenib as a first-line option and cabozantinib as a second-line option...Thus, additional selective inhibitors have been approved: larotrectinib and entrectinib for NTRK + tumours, selpercatinib and pralsetinib for RET + tumours, and crizotinib, alectinib and lorlatinib for ALK + tumours. Such a personalized approach increases clinical benefit whilst minimizing adverse events. Future studies should focus on the combination of tyrosine kinase inhibitors and immune-checkpoint inhibitors; currently, there is no strong evidence that redifferentiation strategies add clinical benefit in terms of overall survival or progression-free survival."

Journal • Review • Oncology • Solid Tumor • Thyroid Gland Carcinoma • ALK • NTRK