Alecensa (alectinib) / Roche - LARVOL DELTA

Diffuse cutaneous ALK-immunoreactive histiocytosis with MEF2C::FLT3 fusion. (PubMed, JAAD Case Rep) - No abstract available

Journal • Oncology • MEF2C

GO42286: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Feb 2028 ➔ Feb 2032

Trial primary completion date • Brain Cancer • CNS Tumor • Pediatrics • Solid Tumor • ALK

A successful case report: response to Alectinib and local Radiotherapy in an ALK rearranged non-small cell lung cancer patient harboring multiple brain metastases (WFNOS 2025) - "This case highlights the potential of combining targeted therapies, neurosurgery, and localized radiotherapy to achieve complete CNS responses in ALK+ NSCLC brain metastases, reinforcing the value of personalized, multimodal treatment strategies in oligometastatic ALK+ NSCLC."

Case report • Clinical • CNS Tumor • Colorectal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • CDX2 • KRAS • MET • Napsin A • NKX2-1 • NTRK1 • NTRK2 • NTRK3 • ROS1 • SMAD4

"Tumor mutational burden (TMB) and proliferation as negative prognostic factors for ALK+ lung cancer - first results from the randomized ABP phase 2 trial" (DGHO 2025) - "Aurora kinase A was the most significant member of all three categories with HR 2.33 (p=7E-6) and 2.84 (p=0.0027) for PFS and OS per doubling of gene expression.Brigatinib and alectinib upfront result in comparable median PFS of 2.5 - 3 years. Despite low values, TMB reveals a stronger link with clinical outcomes than other features, while a proliferation signature emerges as potential novel molecular risk factor."

Biomarker • Clinical • P2 data • Tumor mutational burden • Lung Cancer • Oncology • Solid Tumor • ALK • AURKA • EML4 • HRD • TMB • TP53

Clinical characteristics and efficacy of targeted therapy in NSCLC with rare ALK fusions (DGHO 2025) - "Alectinib was the predominant choice of first-line TKI in the rare ALK and in EML4::ALK cohort (around 50%), respectively. Patients with rare ALK fusions derive similar benefit from treatment with ALK-TKI and they should be preferred over platinum-based therapy as first-line palliative treatment."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Palliative care • Solid Tumor • Squamous Cell Carcinoma • ALK • EML4

A case of ALK-translocation in squamous-cell carcinoma of the lung with development of beta-amyloid associated angiitis (DGHO 2025) - "Definitive radiotherapy with 33 fractions of 2 Gy and simultaneous chemotherapy with cisplatin and vinorelbine was performed...Durvalumab had been stopped and treatment was switched to lorlatinib, leading to significant size reduction of the subcutaneous metastasis within 2 weeks... Tumour regression under targeted therapy with lorlatinib was observed within 2 weeks. No exact aetiology for ABRA is known, but autoimmune inflammatory complications of either RA or checkpoint-inhibitor therapy cannot be ruled out."

Clinical • IO biomarker • Immunology • Inflammatory Arthritis • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Squamous Cell Carcinoma • Vasculitis • ALK • EML4 • NKX2-1 • PD-L1 • TTF1

Response to a combination of T-DXd (Trastuzumab-Deruxtecan) plus Alectinib in a patient with ALK-TKI resistant ALK+ NSCLC harboring a common polymorphism MET N375S (DGHO 2025) - "From 2021 to 2023 the patient received sequential ALK-TKIs, including alectinib (9 months, mixed response ), lorlatinib (4 months, PD), brigatinib (4 months, PD) followed by atezo/bev/pac/carbo with a partial remission lasting for 6 months At no time point, on- or off target resistance alterations were detectable. In molecular pathology, NGS is primarily appointed to detect clinically relevant alterations, with a focus on hotspot mutations in driver oncogenes. However, a multitude of putatively benign polymorphisms are detected alongside and their contribution to a given therapy may be complex and potentially underestimated. Close genetic disease monitoring, continuous updates of annotation databases and discussions in molecular tumor boards may help to guide treatment options."

Clinical • Genetic Disorders • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Respiratory Diseases • Solid Tumor • ALK • EML4 • LRRTM4 • TP53

Outcomes of relapsed or refractory mature T/NK-cell lymphomas in the era of novel agents: A nationwide observational Study in Japan (ASH 2025) - P | "The median TTNT of each SA after 2nd- or later-linetherapies (mo, 95% CI) was 10.7 (3.9–17.3) for brentuximab vedotin (BV; n = 53, 21%), 5.0 (2.7–7.1) fortucidinostat (n = 36, 14%), 3.9 (2.6–4.8) for romidepsin (n = 80, 31%), 2.1 (0.4–5.2) for darinaparsin (n = 7,3%), 1.8 (1.3–2.5) for pralatrexate (n = 58, 23%), 1.5 (0.6–NE) for forodesine (n = 8, 3%), 1.1 (0.4–2.4) formogamulizumab (n = 22, 9%), 0.7 (0.4–3.5) for denileukin diftitox (n = 5, 2%), and NR (NE–NE) for alectinib(n = 1, 0.4%). In patients with TFHL, romidepsin (44%) and tucidinostat (18%) yielded median TTNTs (mo,95% CI) of 4.0 (2.6–8.7) and 5.5 (1.9–7.8), respectively... To the best of our knowledge, this study reports the most recent treatment patterns andprognoses for patients with R/R MTNKL. No standard of care has been established, as diverse treatmentpatterns have been observed. SAs resulted in similar survival outcomes to CCs in 2nd-line therapy,despite distinctive clinical Background of the groups."

Clinical • Observational data • Bone Marrow Transplantation • Cutaneous T-cell Lymphoma • Dermatology • Extranodal Natural Killer/T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK

Integration of ALK gene mutations and targeted therapies in pediatric high-risk neuroblastoma: advancements in precision oncology. (PubMed, Ann Med Surg (Lond)) - "Several ALK inhibitors, like crizotinib, ceritinib, lorlatinib, repotrectinib, and alectinib, have shown different levels of success, but resistance to these treatments is still a big challenge. While ALK inhibitors have shown promise, resistance mechanisms necessitate the development of combination therapies and next-generation inhibitors. Future research should focus on optimizing targeted treatment strategies to improve survival outcomes in pediatric patients with ALK-positive neuroblastoma."

Journal • Review • Neuroblastoma • Oncology • Pediatrics • Solid Tumor • ALK

Real world adoption of off-label combination treatment to treat non-small cell lung cancer resistance (AACR-NCI-EORTC 2025) - "The median duration of treatment with off-label combination therapy was 7 months (range: 1-35 months), and was longest for alectinib and capmatinib (15 months ongoing & 25 months, ongoing) and gefitinib and selpercatinib (35 months, ongoing). Evidence to support combination regimens included retrospective cohort studies (n=3), published case reports/series (n=3), and a prospective cohort study (n=1).ConclusionOff-label combination therapy to treat targeted therapy resistance in advanced NSCLC is feasible in an academic health-safety net setting. Additional real-world evidence is needed to clarify best practices with this emerging approach."

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EML4

Sex differences in the tolerability to novel targeted therapies: Insights from a French lung cancer data system (ESMO 2025) - "The most used TTs were Osimertinib (71.5%), Alectinib (15.1%), Lorlatinib (5.4%), Brigatinib (3.9%), Dabrafenib+Trametinib (6.3%), Sotorasib (1.7%), Trastuzumab and Amivantamab (0.6% each), others comprising 1.5%. Our study underscore the need for sex-informed supportive care strategies and inclusive toxicity reporting in clinical trials of TTs. Legal entity responsible for the study Gustave Roussy."

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

PANOBINOSTAT OUTPERFORMS TARGETED THERAPIES IN SYNOVIAL SARCOMA PATIENT-DERIVED TUMOR XENOGRAFT ORGANOIDS (PDXOS) (SIOP 2025) - "While current therapies for SS include ifosfamide and doxorubicin, their efficacy is limited, and surgical resection combined with radiotherapy remains the standard for localized disease...PDXO-1 was treated with panobinostat (HDAC inhibitor), selumetinib, trametinib (MEK inhibitors), and alectinib, brigatinib, lorlatinib (ALK inhibitors) for 24 and 48 hours...These findings highlight the potential of HDAC inhibition as a promising therapeutic approach for SS, particularly for cases with limited response to current treatments. Acknowledgments: FAPESP (2023/14392-0); PRONON SIPAR 25000.211368/2019-41."

Clinical • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • SS18

ANAPLASTIC LARGE CELL LYMPHOMA PRESENTING WITH LEUKEMIA AND REFRACTORY CENTRAL NERVOUS SYSTEM INVOLVEMENT RESPONSIVE TO COMBINATION OF CHEMOTHERAPY, BRENTUXIMAB AND ALECTINIB (SIOP 2025) - "Treatment included COG ANHL12P1 and HLH 2004 (without cyclosporin) with 2 weeks...She proceed with cranio-spinal radiation 1800cGy followed by haploidentical with Stem cell transplant with post-trasplant cyclophosphmaide, conditioning TBI with etoposide. Alectinib may be considered as salvage treatment for ALCL/leukemia ALK-1 + and CNS involvement, further prospective studies are required to confirm this finding."

Anemia • Fatigue • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Thrombocytopenia • ALK

TARGETED MOLECULAR THERAPY AND TUMOR SUPPRESSOR GENE ASSOCIATION IN NEUROBLASTOMA (SIOP 2025) - "These findings suggest that Alectinib primarily exerts its effect through necrosis. The increased expression of tumor suppressor genes following Alectinib treatment may play a role in this process. This highlights the need for careful evaluation of treatment resistance associated with tumor heterogeneity."

Neuroblastoma • Oncology • Solid Tumor • ANXA5 • ATRX • HOXB6 • PHOX2B • TP53

EFFICACY AND SAFETY OF ALECTINIB IN PEDIATRIC PATIENTS WITH ALK-ALTERED ADVANCED/METASTATIC SOLID TUMORS: RESULTS OF THE PEDIATRIC COHORT FROM THE TACKLE PHASE II TRIAL (NCCH1712/MK003) (SIOP 2025) - "Conclusions Pediatric patients with ALK alterations treated with alectinib achieved sustained antitumor activity. The role of alectinib as a tumor-agnostic therapy was supported for pediatric patients as in adults."

Clinical • Metastases • P2 data • Brain Cancer • Glioma • Neuroblastoma • Oncology • Pediatrics • Solid Tumor • ALK

Subsequent therapy and outcomes after first-line alectinib in Asian patients with ALK-positive (ALK+) non-small cell lung cancer (NSCLC): a post-hoc analysis of the ALESIA study (ESMO Asia 2025) - No abstract available

Clinical • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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

EARLY ONSET METASTATIC LUNG ADENOCARCINOMA IN A YOUNG ADULT: A CASE REPORT ON UNCOMMON PRESENTATION AND MULTIDISCIPLINARY MANAGEMENT (CHEST 2025) - "The patient was initiated on alectinib 600 mg twice daily with good tolerance, The initial presentation—dyspnea, cough, and fever—mimicked benign conditions such as pneumonia or tuberculosis, delaying definitive diagnosis... The rising incidence of lung cancer in never-smokers and younger adults necessitates further research into etiological factors, such as genetic predisposition or environmental exposures. Clinicians must prioritize early biopsy and comprehensive molecular testing in this population to optimize outcomes. This case reinforces that age and smoking history alone cannot exclude malignancy and emphasizes the importance of aggressive diagnostic pursuit in the face of ambiguous initial data."

Case report • Clinical • Metastases • Cough • Infectious Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Tuberculosis • ALK • EGFR • EML4 • Napsin A • NKX2-1 • ROS1 • TP53

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

Patient-derived organoid facilitating personalized medicine in non-small cell lung cancer: two case reports. (PubMed, Front Oncol) - "The corresponding PDO model demonstrated sensitivity to a combination of pemetrexed, carboplatin, and osimertinib, but insensitivity to osimertinib monotherapy...The patient had progressed on multiple lines of therapy, including alectinib and lorlatinib. The PDO model showed sensitivity to brigatinib but insensitivity to ensartinib. Subsequent treatment with brigatinib induced a PR that was sustained for 5.8 months; the patient survived for a total of 9 months following the initiation of this PDO-guided therapy. These two cases suggests that PDOs derived from primary and metastatic lesions may help optimize treatment regimens for patients with lung cancer brain metastases, thereby enabling personalized therapy and potentially improving survival outcomes."

Journal • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • EML4 • NRXN1

Successful and On-going Long-Term Disease Control (>24 Months) with Gilteritinib in an ALK+ NSCLC Patient with Brain Metastasis Who Has Progressed on Multiple ALK TKIs. A Case Report and Review of Literature on Gilteritnib. (PubMed, Lung Cancer (Auckl)) - P1 | "Despite the approval to date of 3 generations of ALK tyrosine kinase inhibitors (TKIs) and the clinical development of a 4th-generation ALK TKI, neladalkib (NVL-655), patients still eventually progress on sequential treatment of various generations of ALK TKIs...Since then, she has been treated with multiple ALK TKIs including crizotinib, alectinib, brigatinib, and lorlatinib sequentially (from age 75 to 80) but requiring dose reduction and interruption of lorlatinib due to neurocognitive toxicity from previous stereotactic brain radiation and resection and eventual discontinuation of lorlatinib...This is the first patient case report with >24 months on-going follow-up demonstrating that gilteritinib could be repurposed as a potent and tolerable ALK inhibitor based on previously reported pre-clinical activity and with potential CNS activity. A Phase 2 trial of gilteritnib in alectinib- or lorlatinib-refractory ALK+ NSCLC is being planned (NCT07140016)."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AXL • EML4 • ROS1

Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma induces apoptosis and is highly effective in preclinical studies (AACR-NCI-EORTC 2025) - "Non-Small Cell Lung Carcinoma (NSCLC) bearing the EML4-ALK fusion (Echinoderm microtubule-associated protein-like 4- Anaplastic Lymphoma Kinase) occurs in approximately 5% of NSCLC. We are also currently monitoring the mice for survival, and tumor measurements recorded at 2 weeks after the end of treatment indicate that tumors in mice that received single drug treatment are regrowing faster than tumors in mice that received combined treatment of QO and alectinib, further emphasizing the clinical relevance of this novel combination in ALK+ NSCLC. Taken together, our in vitro and in vivo data suggest that QO mediated overexpression of TUSC2 in ALK+ NSCLC is effective in decreasing growth and proliferation through the activation of apoptotic pathways, thereby paving the way for a potential clinical trial."

Late-breaking abstract • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CASP3 • CASP7 • EML4 • TUSC2

Induction alectinib or crizotinib for stage III NSCLC harboring ALK fusion: A study with 4-year follow-up. (PubMed, Chin Med J (Engl)) - "Induction ALK-TKIs provided a clinically efficient and well-tolerated therapeutic strategy in locally advanced ALK-positive NSCLC."

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

Real-World Prevalence, Treatment Patterns, and Economic Impact of EGFR- and ALK-Targeted Therapies in Non-Small Cell Lung Cancer: A Nationwide Analysis from Greece. (PubMed, Curr Oncol) - "This nationwide analysis highlights the rapid adoption of second- and third-generation TKIs for EGFR- and ALK-positive NSCLC in Greece, reflecting evolving clinical practice patterns. Although the target patient populations are relatively small, the associated economic burden is considerable. To ensure long-term sustainability of the Greek healthcare system, policymakers should critically assess the cost-effectiveness of these innovative therapies and align resource allocation with value-based care principles."

HEOR • Journal • Real-world evidence • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

A UNIQUE CASE OF LUNG ADENOCARCINOMA WITH CONCURRENT ALK REARRANGEMENT AND DE NOVO MET EXON 14 SKIPPING MUTATION (CHEST 2025) - "To the best of our knowledge, this is the first reported case of metastatic lung adenocarcinoma harboring both ALK and de novo METex14 mutation on presentation, treated successfully with combination ALK-Tyrosine kinase inhibitors (TKI) and MET inhibitor therapy, without any significant adverse effects. The combination of Alectinib and Tepotinib may represent an effective treatment option for ALK+ NSCLC with de novo METex14 mutation. This case also highlights the potential for de novo METex14 mutations to serve as a mechanism of intrinsic resistance to ALK-TKIs, reflecting the importance of early detection of such mutations."

Clinical • Back Pain • Lung Adenocarcinoma • Lung Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • ALK • BRAF • EGFR • EML4 • HER-2 • KRAS • MET • ROS1