Alecensa (alectinib) / Roche - LARVOL DELTA

Haematological toxicities with targeted drugs in tumors: A systematic review and network meta-analysis of randomized controlled trials (ASH 2025) - "1 patient treated with sorafenib plus chemotherapy was reported to have died as a result of pancytopenia and 1 patient treated with chemotherapy (gemcitabine plus cisplatin) died due to anemia. Our study confirmed that chemotherapy with or without a placebo, one targeted drug with chemotherapy was associated with more severe hematologic toxicities compared with the use of one targeted drug, tepotinib plus gefitinib, tivantinib plus erlotinib. In the targeted drug monotherapy category, for the primary outcome, we found that alectinib and gefitinib had a higher risk of all-grade (grade 1-5) and severe-grade (grade 3-5) anemia, respectively...Ganitumab plus chemotherapy had the highest risk of grade 1-5 anemia and thrombocytopenia. Afatinib plus chemotherapy had the highest risk of grade 3-5 anemia and thrombocytopenia. Ramucirumab plus chemotherapy had the highest risk of grade 1-5 and 3-5 neutropenia. Veliparib plus chemotherapy had the highest risk of grade 1-5 and 3-5..."

Retrospective data • Review • Febrile Neutropenia • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia

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

ALK -positive lung cancer in India: Real world barriers to precision oncology (ESMO Asia 2025) - "Concomitant mutation with TP53 was seen in 5 patients and with EGFR in 3 patients.In the first line 29(48%) patients received crizotinib,15(25%), ceritinib, 4(6%) alectinib, 6(10%) chemotherapy, 3(5%) lorlatinib. ALK positivity was seen in 10% of NSCLC patients. Survival rates of ALK positive lung cancer has improved significantly with the advent of targeted therapy. CNS progression on first generation TKI remains a challenge as most of the patients are deprived of newer generation TKI due to financial constraints."

Clinical • IO biomarker • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • TP53

A multi-centre, real-world study of treatment patterns and outcomes in Anaplastic Lymphoma Kinase (ALK)-rearranged non-small cell lung cancer: The Singapore experience (ESMO Asia 2025) - "ALK tyrosine kinase inhibitors (TKIs) such as crizotinib, ceritinib, alectinib, brigatinib and lorlatinib are among the therapeutic options. ALK TKIs are effective in treating ALK-rearranged NSCLC in the real world setting, mirroring results from randomised trials. Factors to consider in deciding 1L TKI include overall and BM efficacy and toxicities."

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

Poor efficacy of first-line alectinib or lorlatinib in advanced ALK-rearranged NSCLC with MET overexpression (ESMO Asia 2025) - "First-line alectinib or lorlatinib demonstrated poor efficacy in advanced ALK-rearranged NSCLC with concurrent MET overexpression. Further investigations are warranted to elucidate the underlying mechanisms and identify potential therapeutic strategies."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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) - P3 | "This exploratory analysis suggested that for Asian pts progressing on 1L alectinib, subsequent targeted therapy, particularly with a 3G ALKi, was associated with prolonged clinical benefit. Given the limited sample size and potential confounders, these findings should be interpreted with caution and warrant further studies."

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

Plasma cfDNA analysis of alectinib resistance-related gene alterations in the J-ALEX study (ESMO Asia 2025) - "Plasma cfDNA analysis using NGS is feasible and offers insights into alectinib resistance mechanisms. Early detection of resistance-associated mutations may guide personalized treatment strategies. Larger prospective studies are needed to validate these findings."

Cell-free DNA • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • MET • NRAS

Increased Cardiovascular Risk With Lorlatinib in Patients With ALK-Mutated Lung Cancer: A Real-World Comparative Study. (PubMed, J Am Heart Assoc) - "These findings underscore the importance of routine cardiovascular monitoring, particularly in older patients and those with atrial arrhythmias."

Journal • Real-world evidence • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Lung Cancer • Myocardial Infarction • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

Neoadjuvant Tyrosine Kinase Inhibitors. (PubMed, Thorac Surg Clin) - "However, pathologic response rates are lower than rates after neoadjuvant immunotherapy, and currently, no data demonstrate that neoadjuvant TKI use improves survival. Use of neoadjuvant TKI remains limited to limited to clinical trials, but this may change soon."

Journal • Review • Oncology

Competing Beyond the First Mover: How Late to Market Analogues Navigate Pricing and Access in Major Global Markets (ISPOR-EU 2025) - "HTA, pricing outcomes and payer perceptions for ten analogues (such as Alecensa, Zejula, Rozlytrek, Eylea, Fasenra) were analysed across seven global markets (US, Germany, France, Spain, UK, Brazil, Canada). Several distinct pricing strategies (discounting, parity or premium) were observed which were highly dependent on the level of clinical differentiation vs. earlier to market options. Analogue assessment considered clinical and other non clinical factors that impacted their pricing and access success or failure which can potentially be used as a guide for future portfolio development and optimisation. Demonstrating clinical differentiation vs. earlier entrants is the critical factor translating into positive HTA outcomes and securing a price premium."

Clinical • Pricing

Perioperative Treatment of Lung Cancer:Historical Developments, Current Evidence, and Future Perspectives (PubMed, Kyobu Geka) - "ICIs have become a standard component for resectable stageⅡ-Ⅲ NSCLC, while osimertinib and alectinib established new standards for EGFR- and ALK-positive tumors, respectively. Remaining challenges include optimal patient selection, integration with surgery, and biomarker development. Future directions point to personalized strategies incorporating circulating tumor deoxyribonucleic acid (ctDNA) monitoring and novel therapies to further enhance prognosis in resectable NSCLC."

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

Alectinib versus crizotinib as the first-line treatment in patients with advanced ALK-positive non-small cell lung cancer: a Chinese real-world cohort study. (PubMed, Transl Lung Cancer Res) - "While the presence of bone, liver, and adrenal metastasis were independent risk factors for OS. Alectinib is recommended over crizotinib in the treatment of patients with ALK-positive NSCLC."

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

Real-world first-line outcomes of alectinib and brigatinib in anaplastic lymphoma kinase-positive non-small cell lung cancer: a nationwide South Korean cohort study using the health insurance review and assessment data. (PubMed, Transl Lung Cancer Res) - "Transition to lorlatinib was associated with extended survival in both groups, reflecting its use as a later-line therapy following resistance. Alectinib demonstrated superior disease control in terms of PFS. Further research is warranted to optimize treatment sequence strategies for ALK inhibitors."

Journal • Real-world evidence • Reimbursement • US reimbursement • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Neoadjuvant Alectinib in a Patient With Anaplastic Lymphoma Kinase (ALK)-Mutant Stage III Lung Adenocarcinoma: A Case Report. (PubMed, Cureus) - "Initial treatment with chemoimmunotherapy was complicated by hypersensitivity reactions to nivolumab and paclitaxel, leading to a brief hospitalization...This case demonstrates the efficacy of neoadjuvant alectinib in managing ALK-mutant stage III lung adenocarcinoma, highlighting the potential benefits of targeted therapy in the neoadjuvant setting. Further studies are needed to establish optimal treatment protocols for patients with ALK-positive lung cancer."

IO biomarker • Journal • Immunology • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4

Detection of Targetable Genetic Alterations in SMARCA4-Deficient Neoplasms of the Lung - Further Evidence of a Relationship Between SMARCA4-Deficient Undifferentiated Tumor and Non-Small Cell Carcinoma. (PubMed, Hum Pathol) - "The patient with EML4::ALK fusion was treated with alectinib with partial response...These finding further suggest that SMARCA4d-UT and carcinomas with SMARCA4 loss may be on the same spectrum of disease, and accurate histologic distinction between these lesions may be challenging. A unified terminology may be beneficial for appropriate diagnosis and treatment."

IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Thoracic Cancer • ALK • BRAF • EGFR • EML4 • FGFR1 • KRAS • MAP2K1 • PD-L1 • SMARCA4

Survival outcomes of alectinib in postoperative recurrent ALK-rearranged lung cancer. (PubMed, Surg Today) - "These findings suggest that targeted therapy for recurrence is a valuable treatment strategy. Prospective studies are warranted to determine the optimal timing for ALK-TKI initiation."

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

Alectinib and SALL4-Targeted Fatty Acid Oxidation: A Strategy to Combat Oxaliplatin Resistance in Gastric Cancer. (PubMed, Turk J Gastroenterol) - "This research has brought to light that Alectinib targets SALL4 to modulate the FAO process, thereby reducing the oxaliplatin resistance of GC cells. These findings may open up new avenues to tackle chemoresistance in GC."

Journal • Gastric Cancer • Oncology • Solid Tumor • SALL4

Alectinib as salvage therapy for metastatic UIMT following misdiagnosis: A case enabling definitive surgery and prolonged remission. (PubMed, Gynecol Oncol Rep) - "This case highlights the significant efficacy and safety of alectinib in the management of advanced, recurrent, and aggressive UIMT, while also emphasizing the essential role of multidisciplinary management. It provides valuable insights and serves as a reference for the management of similar rare cases."

Journal • Gynecology • Infectious Disease • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health • ALK • CDKN2A • MTAP

Reducing the Burden of Interaction Studies in Cancer Patients Using a Stable Isotopically Labeled Microtracer: A Proof-of-Concept Study with Alectinib. (PubMed, Clin Pharmacol Ther) - "These results showed that the intake of a Dutch breakfast leads to a higher total exposure of alectinib. More importantly, the feasibility of a microtracer food effect study to reduce patient burden was demonstrated."

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

Brief Report: Alectinib with salvage platinum-taxane chemotherapy in a pregnant woman with ALK-rearranged NSCLC and rapid disease progression followed by a successful pregnancy. (PubMed, J Thorac Oncol) - "This is the first reported case of concurrent alectinib and cytotoxic chemotherapy during pregnancy, successfully used in the setting of progressive ALK-rearranged NSCLC. The placental findings align with observations in pregnancies complicated by FGR. This case highlights the potential feasibility and safety of intensification of systemic therapy during pregnancy, and underscores the importance of individualised multi-disciplinary care."

Journal • Cardiovascular • Ischemic stroke • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Cost-utility and budget impact analyses of anaplastic lymphoma kinase inhibitors in Thailand. (PubMed, Sci Rep) - "Sensitivity analyses confirmed that none of the ALK inhibitors were cost-effective compared to chemotherapy. The five-year BIA estimated the budget impact of ceritinib (450 mg/day, 750 mg/day), alectinib (600 mg/day, 1,200 mg/day), and brigatinib at 2,345 (63.81), 3,703 (100.76), 9,830 (267.49), 19,328 (525.92), and 9,502 (258.56) million THB (USD), respectively."

HEOR • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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 (SNO 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

A Rare Case of Hemolytic Anemia after Alectinib That Did Not Recur after Switching to Lorlatinib. (PubMed, Case Rep Oncol) - "This presentation aligns with a case reported in Japan, describing severe hemolytic anemia with morphological changes in erythrocytes under alectinib treatment. This is the first report describing a rapid increase in hemoglobin after pausing alectinib and no relapse of hemolysis after switching to lorlatinib, while the lung cancer remained stable (stable disease)."

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

A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer (clinicaltrials.gov) - P3 | N=200 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Oct 2025 ➔ May 2026 | Trial primary completion date: Oct 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Oncology

OFF-LABEL TREATMENT AND ULTRARARE SARCOMAS - SINGLE INSTITUTION REPORT (CTOS 2025) - "Off-label therapies included: atezolizumab for alveolar ASPS (n=11); ivosidenib and pazopanib for chondrosarcoma (n=11; 2 and 9); imatinib and pembrolizumab for chordoma (n=14; 5 and 9); sirolimus for epithelioid hemangioendothelioma EHE (n=8); cabozantinib for Ewing sarcoma ES (n=11); crizotinib and alectinib for inflammatory myofibroblastic tumor IMT (n=1 and 2); sorafenib for osteosarcoma (n=7); pembrolizumab for sclerosing epithelioid sarcoma SEF (n=2)... Off-label treatments can improve outcomes in ultrarare sarcoma subtypes: ASPS (atezolizumab), EHE (sirolimus), SEF (pembrolizumab). 3-year survival rates and median EFS surpass historical data. Younger patients show more aggressive disease with shorter EFS."

Clinical • Chordoma • Ewing Sarcoma • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor