Ilaris (canakinumab) / Novartis - LARVOL DELTA

Genetic test utilization in adult patients with suspected inborn errors of immunity presenting with rheumatic and musculoskeletal disease: A retrospective single-center study (ACR Convergence 2026) - "Therapeutic modifications were implemented in 25 patients (39.1%), including genotype-driven interventions such as canakinumab and immunoglobulin replacement therapy... Integrated genetic and multidisciplinary evaluation identified IEI-related disorders in a substantial subset of adults with RMD phenotypes, particularly among diagnostically challenging non-ID/AID patients. Combined clinical-genetic assessment may facilitate disease reclassification and support optimal therapeutic decision-making in adult rheumatology practice."

Retrospective data • Genetic Disorders • Immunology • Inflammation • Musculoskeletal Diseases

Comparative Effectiveness, Safety, and Drug Retention of Biologic Therapies in Still's Disease: A Nationwide Real-World Cohort Study (ACR Convergence 2026) - "Drug retention, drug retention excluding remission-related discontinuations, and time to low and very low dose (≤7.5 mg/day and ≤5 mg/day prednisone equivalent) steroid were analyzed using Kaplan-Meier methods and compared with the log-rank test. The study included 114 patients...Anakinra (ANA) was used more frequently in patients with MAS, whereas non-MAS disease activity was the predominant indication for the other biologics. Biologic treatment sequencing also differed among groups, with ANA and tocilizumab (TOCI) more commonly used as a first-line biologic, whereas tumor necrosis factor inhibitors (TNFi) and canakinumab (CANA) were more frequently administered after prior biologic exposure (p< 0.001)... Biologic selection appeared to be influenced by disease phenotype, with ANA preferentially used in MAS and TNFi in chronic articular disease. TOCI showed superior long-term drug retention, while allergic reactions were more common with ANA. Despite differences in..."

Clinical • HEOR • Real-world • Real-world evidence • Immunology

Canakinumab in combination with first-line (1L) pembrolizumab plus chemotherapy for advanced non‑small cell lung cancer (aNSCLC): Results from the CANOPY-1 phase 3 trial (AACR 2022) - "Patients with previously untreated stage IIIB/C or IV NSCLC, of any histology and no known EGFR or ALK alterations, were randomized 1:1 and stratified based on PD-L1 status, geographic region, and histology to canakinumab 200 mg or PBO every 3 weeks, plus pembrolizumab and histology-guided PDC for 4 cycles, followed by maintenance canakinumab or PBO, with pembrolizumab ± pemetrexed. The addition of canakinumab to pembrolizumab plus PDC did not statistically improve PFS nor OS for 1L treatment of patients with aNSCLC. No unexpected safety findings were observed with the addition of canakinumab to pembrolizumab plus PDC."

Clinical • Combination therapy • IO biomarker • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • IL1B • PD-L1

Clinical and laboratory manifestations and treatment of children with TNFRSF1A gene variants. (PubMed, World J Clin Pediatr) - "Variants in the TNFRSF1A gene may cause a wide range of clinical symptoms, including eye and intestinal lesions that are not typical of sJIA. All patients with fever and unusual sJIA symptoms should have molecular genetic testing for TNFRSF1A variants to confirm or exclude AID early. Early diagnosis enables timely therapy and prevents complications. Tocilizumab (39.3%), canakinumab (33.3%), and TNF inhibitors (21.2%) achieved remission in children with TNFRSF1A variants. Some patients required multiple bDMARD switches to achieve remission, highlighting the complexity of treatment decisions in this group."

Journal • Amyloidosis • CNS Disorders • Gastrointestinal Disorder • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Oncology • Otorhinolaryngology • Pain • Pediatrics • Rheumatology • Ventriculomegaly • TNFRSF1A

Atypical Localized Papular Eruption as a Cutaneous Manifestation of Adult-onset Still's Disease During Canakinumab Therapy: a Case Report (EADV 2026) - No abstract available

Case report • Clinical • Immunology

CANOPY-A: Phase III study of canakinumab (CAN) as adjuvant therapy in patients (pts) with completely resected non-small cell lung cancer (NSCLC) (ESMO 2022) - P3 | "Methods CANOPY-A (NCT03447769) is a Phase III study of adult pts with Stage II–IIIB (AJCC/UICC v8), completely resected NSCLC who had received adjuvant, cisplatin-based chemotherapy (CTx; if applicable) and thoracic radiotherapy (if applicable). Conclusions CANOPY-A did not show a DFS benefit with CAN vs PBO after surgery and adjuvant CTx in pts with resected, Stage II–IIIB NSCLC. No new safety signals were identified with CAN treatment."

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IL1B

Predictive molecular signatures for successful tapering of canakinumab in systemic juvenile idiopathic arthritis. (PubMed, Ann Rheum Dis) - "Serum inflammatory markers and targeted gene expression signatures identify patients with sJIA at higher risk of flare during canakinumab tapering. Combined molecular biomarker profiling may enable individualised tapering strategies and support precision medicine approaches for Still's disease."

Journal • Idiopathic Arthritis • Immunology • Inflammation • Rheumatology • ATF6 • BCL6 • CXCL9 • IL18 • IL1B • MAPK1 • PPARG • SLC25A3 • SLC25A37 • SLC5A7 • TNFAIP3

A targeted and safe strategy for post-infarction anti-inflammatory therapy: cardiac-restricted NLRP3 inhibition via a biomimetic nanocarrier (ESC 2026) - "While IL‑1β blockade (e.g., canakinumab) reduces events, it elevates fatal infection risk, highlighting the need for more precise approaches... In preclinical model, macrophage membrane-coated nanoparticles enabled targeted delivery of MCC950 to the infarcted hearts, robustly inhibiting NLRP3/GSDMD‑driven pyroptosis and improving cardiac recovery without systemic toxicity. These findings offer a proof‑of‑concept for a feasible and safe targeted nanotherapy that decouples anti‑inflammatory efficacy from off‑target risks, offering a targeted approach to mitigate post‑infarction inflammatory injury."

Cardiovascular • Myocardial Infarction • Myocardial Ischemia • Reperfusion Injury • CASP1 • IL1B • NLRP3

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: NYU Langone Health | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2027 ➔ Jan 2028 | Initiation date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2027 ➔ Jan 2028

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Orthopedics • Psoriatic Arthritis • Rheumatology

A Non-Randomized Phase 2 Trial of Nadunolimab in Patients With a Smoking History and High-Risk Lung Nodules (IASLC-WCLC 2026) - "Early antagonism of IL-1α and IL-1β in these models delayed progression to invasive lung cancer, a finding consistent with the secondary analysis of the CANTOS trial, which demonstrated reduced lung cancer incidence among patients treated with the IL-1β inhibitor canakinumab. Patients will have imaging performed at 3 months, 6 months, and 12 months following the start of therapy as well as serial blood draws to investigate immunodynamic changes in response to treatment, including analysis of blood cytokines, proteomics, and transcriptomics. The trial will be a Simon's optimal two-stage design, with an initial enrollment of 20 patients in the first stage."

Clinical • P2 data • Lung Cancer • Solid Tumor • IL1B

Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial. (PubMed, J Clin Oncol) - P3 | "CANOPY-A did not show a DFS benefit of adding canakinumab after surgery and adjuvant cisplatin-based chemotherapy in patients with resected, stage II-III NSCLC. No new safety signals were identified with canakinumab."

Clinical • Journal • Cardiovascular • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombosis • CRP • IL1B • IL6

Targeting Inflammation Across the Myocardial Infarction Continuum: Biomarkers, Imaging, and Emerging Therapies. (PubMed, J Clin Med) - "Canakinumab and low-dose colchicine have demonstrated cardiovascular benefit in selected secondary-prevention populations, although recent neutral trials highlight heterogeneity across clinical settings. Integrating inflammatory biomarkers, multimodality imaging, and targeted therapies may improve risk stratification and support personalized secondary prevention. Further evidence is needed to define optimal patient selection and determine whether biomarker- or imaging-guided anti-inflammatory strategies improve clinical outcomes."

Biomarker • Journal • Review • Atherosclerosis • Cardiovascular • Inflammation • Myocardial Infarction • CRP • IL6 • MPO • NLRP3

Targeting Inflammation in Atherosclerosis: Mechanistic Rationale, Clinical Trials, and Regulatory Considerations. (PubMed, Rev Cardiovasc Med) - "Clinical evidence demonstrates that targeting inflammation, independent of lipid lowering, reduces cardiovascular events, as exemplified by agents such as canakinumab and colchicine. Precision medicine approaches, drug repurposing, and innovative delivery systems may help accelerate development. Ultimately, the management of atherosclerosis is shifting toward a multifaceted approach that integrates lipid-lowering, inflammation resolution, and genetic correction to achieve durable cardiovascular protection."

Journal • Review • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Heart Failure • Hematological Disorders • Infectious Disease • Inflammation • Peripheral Arterial Disease • Thrombosis • APOB • CRP • IL1B • NLRP3

Renal Amyloidosis in Pediatric Autoinflammatory Syndromes: Subclinical Onset, Early Biomarkers, and Clues for Timely Characterization and Interventions. (PubMed, J Clin Med) - "Critically, nutcracker syndrome has emerged as the leading cause of proteinuria in colchicine-treated FMF cohorts, accounting for up to 67.5% of proteinuria cases and representing a clinically significant confounder. IL-1 inhibition with either anakinra or canakinumab has demonstrated histological regression of established amyloid deposits in different cohorts of pediatric patients, reinforcing the potential therapeutic value of earlier identification and intervention before overt irreversible glomerular damage comes out...Conventional reliance on 'proteinuria' as the primary surveillance threshold is potentially misleading. A biomarker-guided monitoring approach incorporating serum amyloid-A, urinary NGAL, and renal elastography might offer a clinically actionable pathway toward earlier nephrology referral and targeted IL-1 blockade, with the potential to improve renal prognosis of these children."

Biomarker • Journal • Review • Amyloidosis • Genetic Disorders • Inflammation • Nephrology • Pediatrics • Renal Disease • IL6 • LCN2

A Study to Assess the Effectiveness and Safety of Canakinumab in Clinical Use in Patients With Schnitzler's Syndrome (clinicaltrials.gov) - P=N/A | N=10 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2032 ➔ Nov 2032 | Trial primary completion date: Jun 2032 ➔ Nov 2032

Trial completion date • Trial primary completion date

Effect of Clonal Hematopoiesis Mutations and Canakinumab Treatment on Incidence of Solid Tumors in the CANTOS Randomized Clinical Trial. (PubMed, Cancer Prev Res (Phila)) - P3 | "The cumulative incidence of at least one reported malignancy was lower for patients with TET2 mutations treated with canakinumab vs those treated with placebo. These findings support a potential role for canakinumab in cancer prevention and provide evidence of IL-1β blockade cooperating with CH mutations to modify the disease course."

Clinical • Journal • Cardiovascular • Myocardial Infarction • Solid Tumor • Thrombosis • DNMT3A • IL1B • TET2

Canakinumab or emavusertib for anemia in lower-risk MDS: results of the CANFIRE and LUCAS phase 2, open-label, multicenter trials. (PubMed, Commun Med (Lond)) - P2 | "Inhibition of IL-1β or IRAK4 signaling with canakinumab or emavusertib did not result in hematologic improvement in patients with LR-MDS."

Journal • P2 data • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • IL1B • IRAK4

Targeting Interleukin-1beta to Overcome Adaptive Immune Resistance in Renal Cell Carcinoma (KCRS 2023) - P1 | "We therefore initiated a clinical trial of neoadjuvant anti-IL1ß (canakinumab) plus anti-PD-1 (spartalizumab) in localized ccRCC. We will also identify novel immunotherapy targets in ccRCC, which will be tested in murine models and a high-throughput organoid T cell co-culture system to rapidly accelerate the development of novel combination regimens for ccRCC. This application addresses the KCRP focus on novel therapeutic targets and strategies for kidney cancer."

Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Immune Modulation • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • IL1B

IL-1ß-Driven Inflammatory Networks Define Stage-Specific Vulnerabilities and Inform Lung Precancer Interception (IASLC-WCLC 2026) - P2 | "Furthermore, we conducted a single-arm Phase 2 clinical trial (Can-Prevent-Lung, NCT04789681) evaluating interleukin 1 β (IL-1β) blockade by canakinumab in patients with persistent high-risk (presumably precancerous) IPNs...These findings provide clinical proof-of-concept for IL-1β blockade as a strategy for LUAD precancer interception and highlight that cancer biology—including therapeutic vulnerability—is stage-specific. Together, this supports the development of stage-tailored approaches for lung cancer prevention and treatment."

Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • IL1B • IL1R1

Plasma signals of lung tumor promotion and the ubiquitous challenge of biomarker specificity. (PubMed, Diagnosis (Berl)) - "This opinion paper examines a recently reported 14-biomarker plasma panel designed to predict lung cancer development and identify patients who might benefit from preventive canakinumab treatment...Ultimately, because these markers lack organ specificity, they are not utilized for early detection. The logical next step for this field will be the development of a single multiplex assay to quantify all 14 proteins simultaneously."

Biomarker • Journal • Lung Cancer • Oncology • Solid Tumor • CEACAM5 • MUC16

Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. (PubMed, J Clin Oncol) - "The addition of canakinumab to first-line pembrolizumab and CT did not prolong PFS or OS in patients with NSCLC."

Clinical • Combination therapy • IO biomarker • Journal • Metastases • Hematological Disorders • Infectious Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pain • Pulmonary Disease • Solid Tumor • ALK • CRP • EGFR • IL6

The IL-1β inhibitor canakinumab in previously treated lower-risk myelodysplastic syndromes: a phase 2 clinical trial. (PubMed, Nat Commun) - P2 | "Sequential post-hoc prospective single-cell RNA sequencing analyses of HSPCs and bone marrow mononuclear cells at different time points during therapy showed that canakinumab's on-target effects in hematopoietic populations expressing the IL-1β receptor decreased the TNF-mediated inflammatory signaling pathway but rescued ineffective erythropoiesis only in the context of lower genetic complexity. This study demonstrates that better stratification strategies could target lower-risk MDS patients more effectively."

Journal • P2 data • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • IL1B

Comparative effectiveness of anti-inflammatory therapies for atherosclerotic cardiovascular disease: a systematic review and network meta-analysis of 16 randomised trials (ESC 2026) - "Canakinumab 150 mg and colchicine both significantly reduce MACE in patients with atherosclerotic cardiovascular disease, though colchicine's benefit appears driven by MI prevention rather than mortality reduction. Darapladib and methotrexate are ineffective. The MACE benefit of colchicine persists even after incorporating the neutral CLEAR SYNERGY trial, but the absence of any mortality signal and low confidence of evidence for hard endpoints warrant cautious interpretation and continued investigation."

HEOR • Retrospective data • Review • Atherosclerosis • Cardiovascular • Myocardial Infarction

A phase 2 study of canakinumab in patient with myelofibrosis: Results from part 1 (ASH 2025) - "Introduction Myelofibrosis (MF) is a myeloproliferative neoplasm (MPN) for which the only approved therapies are JAKinhibitors which improve splenomegaly and disease-related symptoms. Given the encouraging impact onMF symptoms, blood counts and reassuring safety profile, the study was amended to enroll pts on astable dose of a JAK inhibitor (ruxolitinib, fedratinib, momelotinib, or pacritinib) who have the potential tobenefit from additional therapy. Part 2 is currently enrolling at multiple sites and updated clinical andcorrelative data will be presented at the meeting."

Clinical • P2 data • Cardiovascular • Fibrosis • Immunology • Myelofibrosis • Myeloproliferative Neoplasm • Thrombocytopenia • CRP • IL1B

Nanomaterial-Based Strategies Targeting IL-1 Signalling in Inflammatory Bowel Disease: Therapeutic Applications and Mechanistic Insights. (PubMed, J Inflamm Res) - "Although biological agents targeting IL-1, such as Anakinra and the neutralizing antibody Canakinumab, have demonstrated anti-inflammatory effects in animal studies and certain clinical trials, challenges including low bioavailability, short half-life, and insufficient targeting specificity remain unresolved. This review summarizes the role of the IL-1 family in the pathogenesis of IBD and advances in nanomaterial-based targeting strategies. Furthermore, by exploring Quality-by-Design (QbD) approaches and personalized nanocarriers, we aim to provide a new theoretical foundation and research direction for the evolution of IBD therapy toward stratified precision medicine."

Journal • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • NLRP3