Zykadia (ceritinib) / Novartis, BeOne Medicines - LARVOL DELTA

Integrative Systems Biology Prioritizes BCL2, ALK, and CDK4 as Therapeutic Candidates in Neuroblastoma through Multi-Centrality Network Analysis, Cross-Database Validation, Independent Docking Validation, and Confidence-Threshold Sensitivity Analysis. (PubMed, Comput Biol Chem) - "This study presents an integrative computational pipeline for network-based drug-target prioritization in neuroblastoma, combining multi-criteria network topology, multi-database biological validation, HDOCK docking with single-trajectory MD stability assessment, and two independent revision-stage verification analyses (AutoDock Vina re-docking and confidence-threshold sensitivity). Within the explicitly reported boundaries of these analyses, BCL2, ALK, and CDK4, together with the AURKA and beta-tubulin axes of Alisertib and Docetaxel, emerge as computationally prioritized candidates for preclinical investigation, with replicate MD simulations on high-performance computing resources and experimental target engagement identified as the required next steps."

IO biomarker • Journal • Inflammatory Arthritis • Neuroblastoma • Oncology • Solid Tumor • ALK • AURKA • BCL2 • CDK4 • MAPT • MIR34A • MYCN

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

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

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

Age-stratified adverse-event reporting signals of seven ALK/ROS1 tyrosine kinase inhibitors in FAERS: a disproportionality and time to onset study. (PubMed, Front Pharmacol) - "The study included 38,479 primary-suspect reports with known age for crizotinib, entrectinib, brigatinib, lorlatinib, repotrectinib, cabozantinib, or ceritinib...The early reporting pattern favors close assessment soon after treatment initiation. FAERS signals remain hypothesis-generating and require confirmation in longitudinal patient-level data."

Adverse events • Journal • Oncology • Pediatrics • ALK • ROS1

Clinicopathological Landscape in ALK+ NSCLC: A 10-Year Study From AIIMS, New Delhi, India (2015-2025) (IASLC-WCLC 2026) - "Results : Among 200 cases, 107 patients received first-line (1L) TKI therapy: Ceritinib (n=52), Crizotinib (n=43), Alectinib (n=9), and Lorlatinib (n=3). However, late disease presentation impacts real-world survival duration, and resource constraints prevent patients from accessing sequential TKI therapy. These findings highlight financial and logistical constraints as key barriers to long term outcomes in ALK+NSCLC."

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

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

Efficacy of Brigatinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer Who Progressed on Alectinib or Ceritinib: ALTA-2 Study. (PubMed, J Thorac Oncol) - P2 | "In ALTA-2, brigatinib demonstrated limited activity in patients with ALK+ NSCLC post-ceritinib or post-alectinib therapy. Median PFS was longer with brigatinib in patients without baseline detectable plasma ALK fusion."

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

Identification of Der p1 inhibitors: Combining AI-based QSAR, molecular docking, molecular dynamics simulations and quantum physics. (PubMed, Comput Biol Chem) - "Molecular docking results revealed that the top three docking scores were -25.5456, -20.6206 and -19.9821 kcal/mol for betrixaban, ceritinib and ivacaftor, respectively. The integrated computational workflow identified Betrixaban as the most promising FDA-approved candidate for Der p1 inhibition based on its favorable overall binding affinity and stable protein complex, while Ceritinib demonstrated superior electronic interactions and hydrogen-bond stability that may support future lead optimization. These findings provide a rational framework for drug repurposing against Der p1 and warrant further experimental validation through biochemical and cellular assays."

Journal • Allergy • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

AKT (Ser473) suppression mediates ceritinib cardiotoxicity through autophagic flux impairment and mitochondrial injury. (PubMed, Acta Pharmacol Sin) - "Metformin co-treatment preserves cardiac function and attenuates apoptosis. These protective effects occur without reversing the suppressed AKT (Ser473) or GSK3β (Ser9) phosphorylation. Together, these findings establish that AKT suppression drives ceritinib cardiotoxicity through autophagic flux impairment and mitochondrial injury, and position AMPK-driven, TFEB-associated lysosomal restoration as a mechanism-based cardioprotective strategy independent of AKT recovery."

Journal • Cardiovascular • Oncology • AKT2 • ALK • AMPK • CTSD • HSPD1 • TFEB

Clinical Evaluation of Anaplastic Lymphoma Kinase (ALK) Inhibitors for the First-Line Treatment of Advanced ALK-Positive Non-Small Cell Lung Cancer Based on the 2nd Edition of China's Drug Evaluation and Selection Guideline. (PubMed, Drug Des Devel Ther) - "The final assessment result scores from highest to lowest were alectinib (78.70 points), lorlatinib (78.70 points), brigatinib (78.50 points), ensartinib (73.30 points), iruplinalkib (72.55 points), ceritinib (71.50 points), envonalkib (71.15 points), crizotinib (70.60 points). Based on the second edition of China's drug evaluation and selection guideline and combined with the clinical application characteristics of ALK inhibitors, this study performed a multidimensional scoring of eight ALK inhibitors. The evaluation results could provide a reference for medical institutions in the introduction and elimination of ALK inhibitors."

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

Rescuing a refractory Leiomyosarcoma: ALK-DCTN1 fusion as a gateway to long-term control with Ceritinib. (PubMed, Gynecol Oncol Rep) - "Over the following decade, she developed progressive pelvic disease requiring multiple debulking surgeries, arterial embolizations, and pembrolizumab, which was stopped due to progression and adrenal insufficiency. This case underscores the importance of comprehensive molecular profiling in advanced uLMS. It demonstrates that targeting rare ALK rearrangements with ceritinib can achieve sustained disease control after conventional therapies have failed or were poorly tolerated."

Journal • Endocrine Disorders • Gynecology • Leiomyosarcoma • Nephrology • Oncology • Renal Disease • Sarcoma • Solid Tumor • Uterine Leiomyoma • Uterine Leiomyosarcoma • Women's Health • DCTN1

Real-world treatment patterns and time-to-treatment discontinuation among advanced ALK-positive non-small cell lung cancer patients. (ASCO 2025) - " Among 680 patients, 1L therapy distribution was as follows: crizotinib (n=366, 53.8%), alectinib (n=267, 39.3%), brigatinib (n=22, 3.2%), and ceritinib (n=25, 3.7%). This study provides real-world evidence on TTD and treatment patterns among advanced ALK+ NSCLC patients. Transition rates to 2L ALK TKIs were lower than expected based on clinical trials, with high rates of discontinuation without transition. With alectinib, brigatinib, and lorlatinib equally recommended as 1L options in US clinical guidelines, these findings provide real-world evidence to help clinicians differentiate among therapies and guide treatment sequencing decisions."

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

Clinical characteristics of ALK-positive NSCLC patients treated with sequential ALK-TKI therapies in a single-centre. (PubMed, Lung Cancer Manag) - "The drugs used were Alectinib in 10 patients, Lorlatinib in eight, Brigatinib in six, Ceritinib in three, and Crizotinib in two. Sequential treatment with different types of ALK-TKIs demonstrated a certain degree of efficacy. However, the incidence of discontinuation due to adverse events was higher for Brigatinib than for other ALK-TKIs."

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

Expert consensus on iruplinalkib for the treatment of ALK-positive non-small cell lung cancer (2026 edition) (PubMed, Zhonghua Zhong Liu Za Zhi) - "Currently, the China National Medical Products Administration (NMPA) has approved ten ALK-TKIs, including crizotinib, ceritinib, alectinib, ensartinib, brigatinib, lorlatinib, iruplinalkib, envonalkib, dirozalkib and conteltinib. This consensus provides systematic and comprehensive update of clinical research data on iruplinalkib published before June 25, 2026, based on the 2024 edition. It covers common clinical issues and provides corresponding recommendations for the use of iruplinalkib in the treatment of ALK-positive NSCLC."

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

Using Tumor Models to Determine Treatments (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: University Health Network, Toronto | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

Combined therapy with ALK inhibitors and a novel EGFR-targeting antibody‒drug conjugate as a strategy for ALK-rearranged non-small cell lung cancers. (PubMed, Oncogenesis) - "Here, we evaluated a novel combinatorial strategy using ALK inhibitors (crizotinib, ceritinib, alectinib, and lorlatinib) in combination with LR004-VC-MMAE in ALK-rearranged NSCLC models...In NCI-H3122 xenografts, this combination achieved synergistic tumor inhibition without increased toxicity compared with either treatment alone. Collectively, our findings demonstrate the synergistic antitumor activity of ALK inhibitor plus LR004-VC-MMAE against ALK-rearranged, EGFR-high NSCLC, providing a mechanistic rationale for further clinical development of this combination strategy."

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

An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: Yonsei University | Unknown status ➔ Completed | Trial completion date: Dec 2019 ➔ Jan 2026 | Trial primary completion date: Dec 2019 ➔ Jan 2026

Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

A hydrogen sulfide activated fluorescence probe for screening tumor cells and diagnosis of non-small cell lung carcinoma. (PubMed, J Photochem Photobiol B) - "Moreover, probe CerYT can exhibit enhanced fluorescence in tumor cells for sensitive tumor cell diagnosis, while simultaneously releasing the inhibitor ceritinib to induce significant damage to tumor cells. Consequently, the synergistic impact of ceritinib with H2S activation offers a highly efficacious diagnosis and therapeutic attribute for tumor cells and carcinoma."

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

Efficacy and safety of second-line treatments in ALK mutation-positive advanced non-small cell lung cancer after second- or third-generation ALK inhibitors: Turkish Oncology Group real-life study (TOG study). (PubMed, Clin Transl Oncol) - "The efficacy of second-line ALK inhibitors is limited in patients receiving potent treatments such as second- and third-generation ALK inhibitors. These findings highlight the limited efficacy of currently available second-line treatment options after failure of potent ALK inhibitors and underscore the need for improved treatment strategies in this setting. Lorlatinib is the most important treatment option in second line, and our results are consistent with real-life data."

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

INFANTILE MYOFIBROMATOSIS OF THE ESOPHAGOGASTRIC JUNCTION: A RARE SOLITARY VISCERAL PRESENTATION (ESPGHAN 2026) - "We report a rare case of solitary visceral IM involving the esophagus and stomach in an infant who exhibited a favorable therapeutic response to ceritinib...The favorable response to ROS1 inhibition highlights the potential utility of targeted therapy in selected patients. Contact e-mail address [email protected]"

Gastrointestinal Disorder • Solid Tumor • CD34

The efficacy of targeted therapy in ALK-positive non-small-cell lung cancer patients and analysis of MET/PD-L1 expression status. (PubMed, Ther Adv Med Oncol) - "Crizotinib showed no significant difference in progression-free survival (PFS) or overall survival (OS) between first-line and post-chemotherapy use (PFS: p = 0.803; OS: p = 0.761). For second-generation ALK-TKIs, first-line treatment had numerically longer PFS compared to post-chemotherapy (alectinib: 41 vs 24 months; ceritinib: 30 vs 8 months), but these differences were not statistically significant after adjustment (p = 0.120 and 0.284, respectively)...Among patients treated with alectinib, there appears to be a trend toward shorter PFS and OS in those with MET overexpression. In a limited number of matched samples, PD-L1 expression did not change significantly after TKI resistance, although a slight increase was observed."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • MET • PD-L1

ALK rearrangements and resistance mutations in non-small cell lung cancer: molecular mechanisms and therapeutic implications. (PubMed, Cancer Chemother Pharmacol) - "ALK inhibitors, including crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib has significantly improved clinical outcomes in ALK-rearranged NSCLC patients. To overcome these resistance mechanisms, the development of novel therapeutic strategies are required. By integrating structural biology, mutation evolution patterns, and emerging therapeutic approaches, this review underscores the need for next-generation inhibitors to overcome resistance and improve long-term outcomes in patients with ALK-positive NSCLC."

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