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

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

KOSMOS-II: KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II (clinicaltrials.gov) - P=N/A | N=1000 | Active, not recruiting | Sponsor: Seoul National University Bundang Hospital | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2026 ➔ Mar 2027

Enrollment closed • Trial primary completion date • Tumor mutational burden • Oncology • Solid Tumor

Late-onset multifocal vitiligo-like depigmentation during brigatinib therapy for ALK-rearranged metastatic lung adenocarcinoma (EADV 2026) - "Within the anaplastic lymphoma kinase (ALK) inhibitor class, published reports of vitiligo-like depigmentation remain rare and have mainly involved alectinib. In patients receiving ALK tyrosine kinase inhibitors, new sharply demarcated hypopigmented or depigmented patches should prompt dermatologic recognition, treatment of visible and quality-of-life burden, and multidisciplinary discussion without automatic interruption of effective cancer therapy. Further reporting is needed to determine whether brigatinib represents a rare ALK-inhibitor-associated depigmentation phenotype and to define latency, clinical spectrum and outcomes."

Metastases • Dermatitis • Dermatology • Immunology • Lung Adenocarcinoma • Lung Cancer • Mood Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Vitiligo • 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

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

Alectinib versus ensartinib in Asian resected ALK-positive early-stage NSCLC: A matching-adjusted indirect comparison (ESMO 2026) - No abstract available

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

Alectinib and Local Therapy for Optimal Treatment in ALK-Positive Non-Small Cell Lung Cancer (ALTHEO Study: NEJ069) (ESMO 2026) - No abstract available

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

Alectinib as a tumour-agnostic intervention for ALK fusion-positive cancers: The DETERMINE trial (ESMO 2026) - No abstract available

Oncology • ALK

Beyond the Tumor: Alectinib-Associated Fluid Retention as an Unexpected Perioperative Airway Threat (ASA 2026) - "Due to airway concerns, endotracheal tube exchange was performed. The patient was diuresed with significant improvement and extubated on postoperative day zero."

Oncology

ATNM-400 Elicits Durable Anti-tumor Responses in KRAS- and ALK-Driven NSCLC Models in a Mutation-Agnostic Manner (EANM 2026) - "Previously, we demonstrated that the ATNM-400 target is overexpressed in EGFR-mutant NSCLC models and exhibits strong efficacy as monotherapy and in combination with osimertinib...In vivo biodistribution and efficacy (monotherapy and combination) were evaluated in xenograft models, including tumors sensitive and resistant to KRAS G12C inhibitors (sotorasib, adagrasib) and ALK inhibitors (crizotinib, ceritinib, alectinib)... ATNM-400 exhibits potent antitumor activity and favorable tolerability across NSCLC models, independent of oncogenic mutation status. Broad baseline and therapy-induced target expression, combined with specific binding and high-linear energy transfer of 225Ac, enhances its efficacy in KRAS-and ALK-driven NSCLC tumors. These findings support ATNM-400 as a mutation-agnostic targeted alpha therapy and justify further translational and clinical development in advanced NSCLC."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • EML4 • KRAS

Unexpected hepatic metastasis from a low-grade meningioma in a patient with ALK-positive lung cancer: a case report (EANO 2026) - "In 2020, following pleural recurrence of lung cancer, systemic therapy with alectinib was initiated... Hepatic metastasis from a WHO grade 1 meningioma represents an exceptionally rare clinical occurrence. Given the absence of standardized treatment guidelines, management should be individualized and guided by multidisciplinary evaluation. This case supports the potential role of locoregional therapeutic strategies, including thermoablation, in selected patients and underscores the need for further evidence to inform optimal management of such rare presentations."

Case report • Clinical • Brain Cancer • Hepatocellular Cancer • Lung Adenocarcinoma • Lung Cancer • Meningioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

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

Improving public cancer care by implementing precision medicine in Norway (clinicaltrialsregister.eu) - P1/2 | N=1000 | Recruiting | Sponsor: Oslo University Hospital HF | N=6000 ➔ 1000

Enrollment change • Oncology

Operationalizing the PMMR Standardized Framework to Manage Patients on TKIs for Non-Small Cell Lung Cancer (NSCLC) (IASLC-WCLC 2026) - "Firstly, TA AE data was collected (Osimertinib, Amivantamab-Lazertinib, Sunvozertinib, Crizotinib, Alectinib, Afatinib, Entrectinib, Selpercatinib, Lorlatinib) based on clinical trial data, regulatory drug labels, and provincial/national guidelines. Details, including barrier and facilitators, and recommendations on implementation will be presented at the conference. Conclusions : To further enhance adherence and treatment efficacy, future directions include: (i) integrating a grading criterion for nurses in the EMR while using the scripts to enhance assessment and (ii) creating a remote monitoring application that leverages PMMR."

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

Nursing Management of KRAS G12C Inhibitor Toxicities in Thoracic Malignancy: A Canadian Perspective (IASLC-WCLC 2026) - "Unlike cell-surface receptor targeting-tyrosine kinase inhibitors (TKIs), such as osimertinib and alectinib, which are familiar to thoracic oncology nurses, KRAS G12C inhibitors act upon an intracellular downstream signaling pathway...While first-in-class inhibitors sotorasib and adagrasib are approved, next-generation agents including divarasib, olomorasib, and calderasib are demonstrating more favourable safety profiles in ongoing trials...As KRAS G12C inhibitors expand beyond NSCLC to broader solid tumour indications, proactive, evidence-informed, and standardized nursing management is essential to optimizing patient outcomes and ensuring equitable access to precision oncology care globally. This requires that nurses be equipped with the education and clinical tools for informed, evidence-based symptom management across geographically diverse healthcare systems."

Hepatology • Interstitial Lung Disease • Liver Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Thoracic Cancer • KRAS

Multiple Options, One Objective: Clearer Decisions in Resectable Non-Small Cell Lung Cancer. (PubMed, Cancers (Basel)) - "Treatment of resectable NSCLC should be individualized based on stage, nodal status, PD-L1 expression, molecular alterations and pCR. Upfront surgery with adjuvant therapy is appropriate for lower-stage disease (IB-IIA), while perioperative chemoimmunotherapy offers maximal benefit in stage II-III, especially N2-positive patients. Biomarker-driven strategies will continue to refine patient selection to stop or continue postoperative treatment."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

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

Biopsy-Confirmed Severe Acute Kidney Injury Requiring Emergent Hemodialysis After Eight Months of Alectinib Therapy. (PubMed, Cureus) - "Renal biopsy revealed mixed acute tubular necrosis and acute interstitial nephritis. This case reinforces the rare association between alectinib and AKI, emphasizing the importance of monitoring for and recognizing signs of nephrotoxicity in patients receiving this therapy, even after months of stable renal function."

Journal • Acute Kidney Injury • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • ALK

Repositioning niclosamide and alectinib to inhibit the hyperphosphorylation of SARS-CoV-2's nucleocapsid protein. (PubMed, Br J Pharmacol) - "This work provides the biochemical basis for a novel approach to treat COVID-19 by synergistically repositioning two FDA-approved drugs."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Targeted Protein Degradation

ALK Me Anything: A Rare Sarcoma's Grand Peritoneal Debut (ACG 2026) - "Pathology revealed ALK-positive EIMS, and the patient was initiated on alectinib. He enrolled in a clinical trial for neladalkib and currently remains on the drug with significant reduction of tumor burden on imaging...Figure: (B) Rearrangement of ALK-1 by Vysis LSI ALK dual color break apart. FISH probe was positive (arrow)."

Dyspepsia • Eosinophilia • Sarcoma • Solid Tumor • ALK

Target Attainment and Clinical and Biochemical Parameters Associated with the Pharmacokinetics of 12 Tyrosine Kinase Inhibitors. (PubMed, Clin Pharmacokinet) - "Target attainment was suboptimal for most TKIs, supporting the need for TDM-guided optimisation and individualised dosing. Associations between TKI exposure and renal, hepatic, and haematological parameters further support personalised treatment strategies."

Journal • PK/PD data • Hematological Disorders • Oncology

Monitoring EML4-ALK Biomarkers via a Microfluidic Assay for Treatment Efficacy Assessment. (PubMed, Biosensors (Basel)) - "Crucially, we showcase the platform's distinct applicability to functional assays by monitoring dynamic phosphorylation changes in EML4-ALK following treatment with the tyrosine kinase inhibitor alectinib, successfully capturing a significant, rapid decrease in phosphorylation levels. At this preclinical stage, the platform demonstrates analytical and functional feasibility for highly sensitive and rapid biomarker monitoring, providing a foundation for future validation in patient-derived ALK-positive samples for therapeutic-response assessment."

Biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4

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