Alecensa (alectinib) / Roche - LARVOL DELTA

Beyond Risk Factors: A Young Non-smoker's Battle With Metastatic Lung Cancer (ATS 2025) - "Molecular testing revealed an ALK fusion, leading to the initiation of alectinib, an effective targeted therapy for ALK-positive NSCLC...Future research should focus on identifying genetic alterations associated with early-onset, advanced NSCLC to improve understanding and management. Early diagnosis and targeted therapies can significantly improve outcomes, emphasizing the importance of clinician awareness."

Clinical • Metastases • Cardiovascular • Endocrine Disorders • Endometriosis • Gynecology • Hematological Malignancies • Lung Adenocarcinoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Pain • Pulmonary Embolism • Respiratory Diseases • Solid Tumor • Women's Health • ALK • NKX2-1

Caught in the Lung Crossfire: Fatal Case of Lorlatinib-induced Pneumonitis and ARDS in a Patient With ALK-positive NSCLC (ATS 2025) - "Lorlatinib-induced pneumonitis is infrequently reported, but early recognition is crucial as it can progress to life-threatening respiratory failure.Case Description: We present a case of a 63-year-old non-smoker man who was initially diagnosed with stage IIIA NSCLC, underwent left upper lobectomy, followed by adjuvant chemotherapy with four cycles of Alimta and Cisplatin, followed by adjuvant Alectinib. Early drug discontinuation and corticosteroid therapy are critical, but even with aggressive management, outcomes may be poor. This case highlights the need for further research into the pathophysiology and risk factors associated with TKI-induced pneumonitis to improve outcomes and guide future therapy."

Clinical • Acute Respiratory Distress Syndrome • Infectious Disease • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • ALK

Resistance to Anti EGFR Through the Successive and Cumulative Acquisition of Two New Oncogenic Addictions: BRAF and ALK (ATS 2025) - "She received Gefitinib on the first line...Following progression on chemotherapy, the patient receives targeted therapies combining Dabrafenib, Trametinib and Osimertinib. Due to a dissociated response after 4 months of treatment, a 5th line of Paclitaxel Bevacizumab was initiated. Following a new progression and the presence of an ALK rearrangement on the re-biopsy, treatment with Alectinib was then proposed. The response was dissociated and a final line was therefore proposed before stopping active treatments for toxicity and deterioration in general condition. This case reports a resistance to anti-EGFR by the successive and cumulative acquisition of two new oncogene addictions and emphasizes the importance of rebiopsy at each progression on targeted therapy if feasible."

CNS Disorders • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Psychiatry • Solid Tumor • ALK • BRAF

Beyond the Lung: A Case of Alectinib-Induced Hypertriglyceridemia Pancreatitis (ATS 2025) - "However, a severe case leading to respiratory failure has been reported. Despite documented increases in amylase levels in clinical trials, pancreatitis is often overlooked as a potential side effect of ALK inhibitors due to its infrequent reporting."

Clinical • Anemia • Dyslipidemia • Hematological Disorders • Hepatology • Hypertriglyceridemia • Immunology • Liver Failure • Lung Adenocarcinoma • Lung Cancer • Myositis • Non Small Cell Lung Cancer • Oncology • Pain • Pancreatitis • Respiratory Diseases • Solid Tumor • ALK

ECMO in a Stage IV Lung Cancer Patient: A Case for Expanding Indications in the Era of Cancer Remission (ATS 2025) - "However, as cancer treatments improve and patients with advanced disease achieve remission, the need to reevaluate these institutional policies should be explored.This case illustrates the successful use of ECMO in a patient with stage 4 lung cancer who presented with ARDS.Case Presentation: A 54-year-old male with a history of stage 4 lung cancer with brain metastasis, currently in remission after three years of treatment with Alectinib, was admitted with a vasovagal syncopal episode, and headache, however on day three of admission he was diagnosed with hospital-acquired pneumonia...As oncology continues to evolve, with many patients achieving prolonged remissions in the era of rapidly changing cancer treatments, critical care protocols should adapt to consider the potential benefits of ECMO in patients with metastatic cancer. This case advocates for a broader application of ECMO and challenges the current contraindications to not consider in advance cancer patients."

Clinical • Metastases • Acute Respiratory Distress Syndrome • Brain Cancer • Infectious Disease • Lung Cancer • Oncology • Pain • Pneumonia • Respiratory Diseases • Solid Tumor

CUPISCO: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (clinicaltrials.gov) - P2 | N=528 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Nov 2024

Trial completion • Trial completion date • Oncology

IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - P3 | N=1000 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology

SPRING: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Peking University Shenzhen Hospital

Biomarker • New P2 trial • Oncology

Advancing targeted therapies in oncology: The role of alectinib in managing ALK-positive non-small cell lung cancer. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Alectinib in children and adolescents with solid or CNS tumors harboring ALK-fusions: A data update from the iMATRIX alectinib phase I/II open-label, multi-center study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT04774718 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P1/2 data • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Efficacy and safety of alectinib in pediatric and adult patients with ALK altered advanced solid tumors: Results from the TACKLE phase II trial, a MASTER KEY substudy (NCCH1712/MK003). (ASCO 2025) - "Clinical Trial Registration Number: jRCT2091220364 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Oncology • Pediatrics • Solid Tumor

Neladalkib (NVL-655), a highly selective anaplastic lymphoma kinase (ALK) inhibitor, compared to alectinib in first-line treatment of patients with ALK-positive advanced non-small cell lung cancer: The phase 3 ALKAZAR study. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT06765109 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Clinical relevance of starting alectinib at a reduced dose in patients with ALK-positive non-small cell lung cancer. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Real-world comparative outcomes of alectinib and brigatinib in ALK-positive non–small cell lung cancer: A retrospective cohort analysis using HIRA data. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Alectinib as neoadjuvant treatment in potentially resectable stage III ALK-positive NSCLC: Final analysis of ALNEO phase II trial (GOIRC-01-2020-ML42316). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05015010 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Semaglutide impairs bioavailability of alectinib: a note of warning based on a cross-over pharmacokinetic drug-drug interaction study. (PubMed, Cancer Commun (Lond)) - No abstract available

Journal • PK/PD data

Alectinib Pharmacokinetic in Patients With NSCLC (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Instituto Nacional de Cancerologia de Mexico | Trial primary completion date: Dec 2024 ➔ Dec 2025

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

Efficacy and safety of toripalimab adjuvant therapy of high-risk factors in stage IA2-IB NSCLC without EGFR and ALK mutation after complete resection treatment (TORAT): A prospective, single-arm study (AACR 2025) - "ADUARA study showed that in the IB subgroup of patients with EGFR mutations, postoperative use of osimertinib can reduce the risk of recurrence or death by 61%, ALINA shows that postoperative use of alectinib can reduce the risk of recurrence or death by 79% in IB patients with ALK mutations...Keynote091 shows that pembrolizumab prolongs the DFS effect in postoperative adjuvant therapy (53.6 vs 42.0; HR 0.76)...Exploratory endpoints include the correlation between genomic changes (mutations, copy number changes (CNV), structural changes, etc.), gene expression profiles, and the efficacy of trastuzumab in pre-treatment lesions and peripheral blood, tumor recurrence and peripheral blood during treatment, and the recurrence mechanism of trastuzumab in early NSCLC. 8 of planned 51 patients have been enrolled by December 31, 2024."

Clinical • IO biomarker • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-1

Disproportionality Analysis of ALK Inhibitor-Induced Hemolytic Adverse Events: A Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database. (PubMed, Can J Physiol Pharmacol) - "The findings highlight alectinibs potential hemolytic risk, necessitating hematologic monitoring. Proposed mechanisms include immune-mediated hemolysis, direct cytotoxicity, and metabolic variability. Routine hemoglobin and bilirubin assessments, along with clinical vigilance, are essential. Further studies are needed to elucidate mechanisms of causality and optimize patient safety."

Adverse events • Journal • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Clinical Relevance of Starting Alectinib at a Reduced Dose in Patients with ALK-Positive Non-Small Cell Lung Cancer. (PubMed, Cancer Res Treat) - "Alectinib at 300 mg twice daily seems an acceptable dose in East Asians with ALK-positive NSCLC. Notably, our data favor 300 mg twice daily in patients with lower body weight and no baseline brain metastasis, considering the more tolerable safety profiles and the potential to reduce medical costs."

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

Case Report: A novel ELMOD3-ALK and EML4-ALK double-fusion responses to neoadjuvant alectinib in a lung adenocarcinoma patient. (PubMed, Front Pharmacol) - "This is the first report of one lung adenocarcinoma patient with a novel ELMOD3-ALK, EML4-ALK double-ALK fusion. This double-ALK fusion variant is sensitive to alectinib, suggesting patients with an ELMOD3-ALK, EML4-ALK double-ALK fusion could achieve clinical survival benefit from alectinib."

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

Impact of Recurrence Modelling on Cost-Effectiveness of New Treatments for Early Cancers (ISPOR 2025) - "This study addressed these challenges using a cost-effectiveness analysis of alectinib as an adjuvant therapy for resected ALK-positive non-small-cell lung cancer as an example. A three-state partitioned survival model (recurrence free, progressive disease, and death) was developed using digitized trial data from ALINA for RFS and overall survival (OS) data from ANITA for chemotherapy... Accounting for recurrence and related impacts over long-term is important for evaluating early cancer treatments. Cost-effectiveness results are significantly influenced by recurrence survival modeling, time horizons and subsequent treatment costs. Future economic evaluations of early cancer treatments should address these uncertainties with more mature survival data and consider all relevant costs over patient's lifetime."

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

Do Utility Scores Derived From Different Preference-Based Measurements Influence the Results of Cost-Effectiveness Analysis? (ISPOR 2025) - "The model B was built to compare sintilimab with camrelizumab as 1st-line therapy. The model C was built to compare anlotinib with support care as 3rd-line therapy...Utilities were derived from a multicenter cross-sectional study involving 20 hospitals in 18 regions of China, which collected EQ-5D-5L and SF-6Dv2 data from 947 patients with NSCLC. In model A, when utilities were measured by Q-5D-5L, compared with chemotherapy, alectinib provided 1.91 additional QALYs (10.08 QALYs vs. 8.18 QALYs)... The utilities measured by EQ-5D-5L were higher than those measured by SF-6Dv2, and the utilities measured by SF-6Dv2 were more clustered across different health states. Compared to using the utilities measured by SF-6Dv2, using EQ-5D-5L results in a higher QALY and larger incremental QALY. This difference would further expand as the patient's survival time increases."

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

Challenges in Projecting Treatment Journeys for ALK-mutated NSCLC: Addressing Uncertainty in PPS and Immature Overall Survival Data (ISPOR 2025) - "We aimed to evaluate the incorporation of RWE to address the PPS using data from 126 patients with ALK-mutated stage IV NSCLC from Oncoclínicas&Co/MedSir, Brazil between 2007 and 2024. We analyzed RCTs and RWE for patients with ALK-mutated stage IV NSCLC treated with third-generation TKIs: lorlatinib, alectinib, and brigatinib. The lack of a defined PPS standard and immature OS data increases uncertainty in treatment projections. While RWE mitigates gaps, robust sensitivity analyses remain critical to account for variability in post-progression outcomes."

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

Optimized Treatment Sequences for ALK+ Stage IV NSCLC: Cost-Effectiveness Analysis From RCT data and Real-World Evidence (ISPOR 2025) - "This study aims to analyze the cost-effectiveness relationship between randomized clinical trials (RCT) and real-world evidence (RWE) involving 126 patients with ALK-mutated stage IV NSCLC from Oncoclínicas&Co/MedSir, Brazil, between 2007 and 2024. An analytical decision model was developed, considering transitions between six health states: first-line progression-free survival (PFS) with tyrosine kinase inhibitors (TKIs; lorlatinib, alectinib, brigatinib), first-line post-progression survival (PPS), second-line PFS with TKIs, third-line PFS with chemotherapy, PPS, and death. RWE clarified some uncertainties in the model, but the cost-effectiveness ratio remains unfavorable across both models, likely due to the high costs of the evaluated technologies."

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