Alecensa (alectinib) / Roche - LARVOL DELTA

BFAST: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2/3 | N=1000 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Aug 2028 ➔ Oct 2026 | Trial primary completion date: Aug 2028 ➔ Oct 2026

Trial completion date • Trial primary completion date • Tumor mutational burden • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF

Does Sex Matter? Real-World Progression-Free Survival of Patients Treated with Alectinib for ALK+ mNSCLC (ESMO 2025) - No abstract available

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

A Real-World Efficacy and Safety Analysis of Alectinib Versus Crizotinib as Adjuvant Therapy in Resectable ALK-Positive Non-Small-Cell Lung Cancer (ESMO 2025) - No abstract available

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

Adjuvant alectinib versus platinum-based chemotherapy in resected stage IB–IIIA ALK+ NSCLC: a cost-effectiveness analysis in the French context (ESMO 2025) - No abstract available

Clinical • Cost effectiveness • HEOR • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 2 Trial of Alectinib in ALK-altered Solid Tumours and NSCLC with Negative Standard Care Testing: Australian Molecular Screening and Therapeutics (MoST) Substudy 14 (ESMO 2025) - No abstract available

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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) - No abstract available

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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) - No abstract available

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

WHEN TARGETED THERAPIES BACKFIRE: A CASE OF ALECTINIB-INDUCED LUNG INJURY (CHEST 2025) - No abstract available

Clinical • Respiratory Diseases

Study Investigates Tailored Sequencing Strategies to Extend Survival in ALK-Positive Advanced NSCLC (Cancer Nursing Today) - "The study...was presented as an abstract at the 2025 World Conference on Lung Cancer....Although the analysis of OS remains in progress, according to the available PFS findings, lorlatinib in the first line demonstrated the longest PFS of approximately 5 additional years compared with alectinib or brigatinib in the first line....The investigators stated that first-line lorlatinib as the initial step in treatment sequencing for ALK-positive advanced NSCLC 'may yield the longest PFS' compared with second- generation therapies, 'regardless of types of subsequent treatments'."

Clinical data • Non Small Cell Lung Cancer

In Vitro and In Vivo Evaluation of Alectinib-Loaded Dendrimer Nanoparticles as a Drug Delivery System for Non-Small Cell Lung Carcinoma. (PubMed, Pharmaceutics) - "Pharmacokinetic analysis indicated enhanced absorption (shorter Tmax), prolonged systemic circulation (longer half-life), and higher bioavailability (increased AUC) for the dendrimer-complexed drug. These findings suggest that the G4-NH2-PAMAM dendrimer system significantly improves Alectinib's pharmacokinetics and therapeutic potential, making it a promising approach for NSCLC treatment."

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

Immune-Related Gene Expression Profiling and ALK-TKI Efficacy for Patients With ALK-Rearranged Non-Small Cell Cancer (IASLC-WCLC 2025) - P=N/A | "Conclusions : High CD8 positive T cells infiltration in ALK -rearranged tumor might be associated with longer duration of alectinib efficacy. Anti-angiogenic therapies may enhance anti-tumor immunity and potentially augment the efficacy of alectinib in patients with ALK -rearranged NSCLC harboring low CD8 positive T cells infiltration."

Clinical • Gene expression profiling • IO biomarker • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • ALK • ANGPT2 • CD8 • CDH1 • CXCL10 • CXCL9 • FLT1 • IDO1 • LAG3 • SNAI1

Comprehensive genomic profiling to guide personalized targeted and immunotherapy in gastrointestinal tumors: Subgroup analysis of the ROME trial (ESMO-GI 2025) - P2 | "Funding: Erlotinib, Pertuzumab, Vemurafenib, Trastuzumab Emtansine, Alectinib, Vismodegib, Cobimetinib, Atezolizumab, Trastuzumab, Ipatasertib (GDC-0068), Entrectinib and Pralsetinib were provided by Roche; Everolimus, Lapatinib, Alpelisib were provided by Novartis, Palbociclib and Talazoparib were provided by Pfizer, Ipilimumab and Nivolumab were provided by Bristol Myers Squibb (BMS); Brigatinib was provided by Takeda Pharmaceutical Co.; Ponatinib, Itacitinib (INCB039110), Pemigatinib (INCB054828) were provided by Incyte; Selpercatinib was provided by Eli Lilly; Tepotinib was provided by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945). CGP with MTB-guided TT may identify patients with GI cancer who benefit from targeted therapies not routinely available in clinical practice. The roles of TMB and potential disease-specific thresholds deserve further investigation."

IO biomarker • Tumor mutational burden • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA • TMB

Phase 3 Trial of Crizotinib vs Observation for Surgically Resected Early-Stage ALK+ NSCLC (IASLC-WCLC 2025) - " 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. Adjuvant crizotinib does not prolong DFS in resected ALK+ NSCLC"

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Sensitive analysis of tyrosine kinase inhibitors in plasma using polypropylene fabric-solid phase extraction combined with liquid chromatography-tandem mass spectrometry. (PubMed, J Chromatogr A) - "Integrated with liquid chromatography-tandem mass spectrometry (LC-MS/MS), the method enabled sensitive determination of eight clinically relevant TKIs (afatinib, alectinib, ceritinib, dasatinib, sunitinib, pazopanib, tamoxifen, and ibrutinib) in plasma. Its practical applicability was validated in spiked plasma under a single-blind design, yielding relative errors of -8.2 % to 5.4 %. Compared to traditional SPE methods, PPF-SPE offers significant advantages in operational simplicity, cost-effectiveness, high throughput, and environmental sustainability."

Journal

Incidence and risk factors of pneumonitis in ALK-rearranged non-small cell lung cancer patients treated with alectinib and thoracic radiotherapy. (PubMed, Transl Lung Cancer Res) - "The combined use of alectinib and TRT significantly increased the risk of TRP. Clinicians should consider the elevated risks and related dosimetric factors when deciding on combination treatment for ALK-rearranged NSCLC patients."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • ALK

Alectinib as Adjuvant Therapy in Resected ALK-Positive NSCLC: A Prospective Multicenter Cohort Study in China (IASLC-WCLC 2025) - P | "The safety profile of alectinib as an adjuvant treatment in resected ALK-positive NSCLC in routine clinical practice will be evaluated. The study also explores prognostic factors of recurrence, the healthcare utilization before or after the recurrence, the alterations of ALK or other biomarkers identified between the recurrence and initiation of the next anticancer therapy, and treatment options after recurrence."

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

STRN/ALK Fusion-Positive Papillary Thyroid Carcinoma Following Childhood Craniospinal Radiation (ATA 2025) - "ALK inhibitors, such as crizotinib and alectinib, have shown efficacy in treating ALK-rearranged non-small cell lung cancer and are being explored in thyroid cancers harboring ALK fusions. We describe STRN/ALK fusion-positive PTC in a patient with a complex oncologic history related to childhood craniospinal radiation. Given the potential for targeted treatment, molecular testing for ALK fusions should be considered in PTC patients, especially those with aggressive disease features or resistance to conventional therapies"

Clinical • Brain Cancer • Lung Cancer • Medulloblastoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma • ALK • BRAF • EML4 • STRN

Economic Burden of Disease Management and Recurrences After Complete Resection of Early-Stage ALK+ Non-Small Cell Lung Cancer (NSCLC) in Spain (IASLC-WCLC 2025) - "Introduction : Adjuvant alectinib has shown a significant benefit with respect to disease-free survival as compared with adjuvant platinum-based chemotherapy (PbCH) in early-stage ALK rearranged non-small cell lung cancer (NSCLC) patients, as well as a mainly low-grade safety profile...Conclusions : Although the number of patients with ALK+ early-stage NSCLC is low, the cost of recurrences (particularly those requiring systemic therapies) represents a substantial burden for the National Health System. Early intervention and the incorporation of more efficacious adjuvant therapies to mitigate recurrence risk are critical to optimize disease management."

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

Precision medicine in colorectal cancer: Personalizing treatment for improved outcomes? (ESMO-GI 2025) - "Other MTT: KRAS G12C inhibitor + Cetuximab (N=18), pan-RAS inhibitor for KRAS G12Cm (N=1), Encorafenib + Cetuximab (N=14) and Dabrafenib + Trametinib (N=1) for BRAF V600Em, Trastuzumab Deruxtecan (N=3) and Tucatinib + Trastuzumab for HER2m/a (N=1), Trametinib for MEKm (N=2), anti LGR5-EGFR bispecific antibody for EGFRm (N=1), Niraparib + Dostarlimab for ARID1Am (N=1), Alectinib for ALKf(N=1) and Inavolisib for PIK3CAm (N=1). Despite no obvious OS benefit of MTT due to small pts number and late MTT lines, this study highlights the different potential targetable MA in 28.9% of pts excluding non G12C RASm. Impact of novel RAS inhibitors and other MTT might change mCRC precision medicine."

IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • ALK • ARID1A • BRAF • KRAS

Final Analysis of Brighstar: LCT With Brigatinib in Tyrosine Kinase Inhibitor-Naïve ALK-Rearranged Metastatic NSCLC (IASLC-WCLC 2025) - P1, P3 | "Individual patient data from a phase 3 trial of brigatinib vs crizotinib (ALTA-1L, NCT02737501) were retrospectively compared...One patient with grade 3 pneumonitis successfully transitioned to full-dose alectinib after resolution with corticosteroids...Conclusions : Brigatinib with LCT is safe in patients with ALK-rearranged advanced NSCLC and yielded promising results when compared to historical outcomes from brigatinib alone. Patients who received comprehensive LCT had superior outcomes, and baseline ctDNA status and radiological volumetric measurements may serve as prognostic biomarkers for treatment response."

Metastases • Anemia • Endocrine Disorders • Gastrointestinal Disorder • Hematological Disorders • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Pneumonia • Renal Disease • Solid Tumor • ALK

A treatment-impact model of alectinib for the prediction of recurrence and associated costs in treating resectable ALK+ non-small cell lung cancer. (PubMed, Lung Cancer) - "Adjuvant alectinib treatment improved population-level clinical outcomes and was predicted to generate cost savings in the US. Predicted alectinib benefits were maximized when all indicated patients were tested for the ALK biomarker."

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

Real-world costs, treatment patterns, and clinical outcomes associated with treatments for advanced anaplastic lymphoma kinase-positive non-small cell lung cancer. (PubMed, J Manag Care Spec Pharm) - "Among 696 patients, the 1L therapy distribution was crizotinib (n = 366), alectinib (n = 267), brigatinib (n = 22), ceritinib (n = 25), and lorlatinib (n = 16). This study highlights the economic burden and variable clinical outcomes among patients with advanced ALK+ NSCLC. These real-world estimates inform cost-effectiveness analyses and clinical decision-making regarding treatment sequencing, particularly given uncertainty surrounding multiple preferred 1L options in clinical guidelines."

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

Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy (clinicaltrials.gov) - P=N/A | N=800 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Mar 2029 ➔ Nov 2029 | Trial primary completion date: Mar 2029 ➔ Jun 2029

Real-world evidence • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Multi-Institutional Study of ALK-Positive Large B-Cell Lymphoma: Outcomes in the Era of ALK Inhibitors and Biologically Informed Therapies. (PubMed, Am J Hematol) - "Twelve patients received ALK inhibitors, with alectinib showing more durable responses than crizotinib. Lenalidomide and immune checkpoint inhibitors also demonstrated activity, including durable complete responses...In conclusion, our findings highlight the limited benefit of chemotherapy, even when intensified or followed by ASCT, and support the integration of biologically targeted therapies, which may have contributed to improved OS in our cohort compared to historical outcomes. Prospective, collaborative studies are needed to better understand disease biology and define optimal use of modern therapies in this rare lymphoma."

Clinical • Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • ALK

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Ulrik Lassen | Trial completion date: Apr 2025 ➔ Apr 2030 | Trial primary completion date: Apr 2024 ➔ Apr 2029

Trial completion date • Trial primary completion date • Oncology