Ilaris (canakinumab) / Novartis - LARVOL DELTA

Efficacy and safety of canakinumab in patients with Adult-Onset Still's Disease: Results from an open-label Phase III study in Japan. (PubMed, Mod Rheumatol) - "Although the primary endpoint was not met, week 28 analysis showed that canakinumab treatment led to improvements in various efficacy outcome measures in Japanese patients with AOSD, with no unexpected safety signals."

Journal • P3 data • Immunology • Infectious Disease

Biological Therapies for Urate Lowering and Inflammation Control in Gout Management. (PubMed, J Inflamm Res) - "Pegloticase achieves sustained urate reduction in refractory gout. Concomitant immunomodulatory therapy using methotrexate or mycophenolate substantially improves response rates by mitigating antidrug antibody formation...Anakinra accumulated extensive off-label evidence over two decades without formal approval, while rilonacept faced regulatory rejection in 2012 despite demonstrating efficacy. Canakinumab received Food and Drug Administration (FDA) approval in August 2023 after its initial rejection in 2011, becoming the first biologic formally indicated for gout in the United States...OLT1177 has advanced through clinical development after incorporating safety lessons from the hepatotoxicity experience associated with MCC950...Remaining challenges include immunogenicity management, treatment costs that limit accessibility, and incomplete long-term safety characterization. Future progress depends on refining patient selection through predictive biomarkers and..."

Journal • Review • Chronic Kidney Disease • Gout • Immunology • Inflammation • Inflammatory Arthritis • Nephrology • Renal Disease • Rheumatology • Solid Organ Transplantation • Transplantation • NLRP3

Multi-Omics analysis of SAR445399, an IL-1R3 antagonist: anti-inflammatory effects in skin challenges from Phase 1 study (AAD 2026) - "Background: In an innovative proof-of-mechanism study, we evaluated SAR445399, a first-in-class anti-IL-1R3 antibody, in healthy subjects using lipopolysaccharide (LPS) and imiquimod (IMQ) as challenge models, with spesolimab and canakinumab as comparators. SAR445399 effectively modulates key inflammatory mediators and pathways at skin level after LPS and IMQ challenge as demonstrated by comprehensive proteomic and transcriptomic profiling. This observed effect strongly supports the rationale for further clinical development in dermatological conditions where IL-1 and IL-36 signaling play crucial pathogenic roles."

P1 data • Dermatitis • Inflammation • IL17A • IL17C • IL1RAP • IL6

Evidence-Based Information on Newer Drugs for Chronic Spontaneous Urticaria (AAD 2026) - " Bruton Tyrosine Kinase inhibitors, remibrutinib and fenebrutinib, are fast-acting, oral medications with a favorable safety and efficacy in CSU and greater potency in type IIb autoimmune urticaria...Quilizumab, canakinumab, Tezepelumab, and benralizumab are not beneficial in CSU. BTK inhibitors are efficacious in CSU and may be superior to omalizumab for type IIb autoimmune urticaria, where disease control is often delayed and limited with anti-IgE agents. Ligelizumab and dupilumab are safe and effective alternatives to omalizumab for anti-histamine-resistant CSU."

Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL4 • IL4R

A case of cryopyrin-associated periodic syndrome presenting with abdominal symptoms due to a novel mutation NLRP3 p.Ile257Met. (PubMed, Clin J Gastroenterol) - No abstract available

Journal • Inflammation • NLRP3

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=627 | Recruiting | Sponsor: Novartis Pharmaceuticals | Initiation date: Dec 2018 ➔ Apr 2015

Trial initiation date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=627 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=673 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Jun 2022 ➔ Jul 2021

Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=673 | Terminated | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2026 ➔ Jan 2026 | Active, not recruiting ➔ Terminated; Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns

Trial completion date • Trial termination • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=627 | Recruiting | Sponsor: Novartis Pharmaceuticals | Initiation date: Apr 2015 ➔ Dec 2018

Trial initiation date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=673 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jun 2027 ➔ May 2026

Trial completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=673 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=673 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jul 2024 ➔ Jun 2027

Trial completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=627 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: May 2021 ➔ Jun 2022

Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=675 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2023 ➔ Sep 2023

Trial completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=627 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P3 trial • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=673 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=627 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=627 | Recruiting | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov) - P3 | N=675 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2023 ➔ Jul 2024

Trial completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Concomitant use of canakinumab may lead to steroid-free dosing of pegloticase (EULAR 2026) - No abstract available

Phenotype-genotype correlation and treatment outcomes in mevalonate kinase deficiency: A large Turkish cohort. (PubMed, Semin Arthritis Rheum) - "The variability in clinical manifestations and treatment responses across genotypes highlights the complexity and heterogeneity of MKD, suggesting that factors beyond genotype may influence disease expression and therapeutic outcomes. We also confirm that heterozygous individuals may express the disease phenotype."

Journal • Amyloidosis • Dermatology • Hidradenitis Suppurativa • Immunology • Musculoskeletal Pain • Otorhinolaryngology • Pain • Pancreatitis • Pediatrics • Rheumatology

Demyelination Reported with Biologic Therapies for Rheumatologic and Inflammatory Bowel Diseases: Insights from FAERS (AAN 2026) - "Mechanistic classes included: anti–tumor necrosis factor (TNF)-α agents, anti-integrin antibodies (excluding natalizumab), anti-interleukin agents (including IL-12/23, IL-23, IL-17, IL-6, and IL-1 inhibitors), B-cell targeted therapies (excluding rituximab), and T-cell co-stimulation modulators... Safety signals for demyelination were identified with TNF-α inhibitors (infliximab, adalimumab, certolizumab pegol, golimumab, and etanercept) with a PRR of 7.34 (95% CI: 6.75–7.98), and abatacept, a selective T-cell co-stimulation modulator (PRR: 2.12; 95% CI: 1.41–3.20). No safety signals were observed for IL-12/23 inhibitors (ustekinumab), IL-17 inhibitors (secukinumab, ixekizumab, bimekizumab), IL-23 inhibitors (mirikizumab, guselkumab, tildrakizumab, risankizumab), and anti-α4β7 integrin (vedolizumab). Reporting counts were insufficient for IL-6 inhibitors (tocilizumab and sarilumab), IL-1 inhibitors (anakinra, canakinumab, and rilonacept), and B-lymphocyte stimulator..."

Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • IL12A • IL17A • IL23A

The use of non-TNF targeted biologics in Behçet's Disease: Real-life data from the International AIDA Network Behçet's Disease Registry. (PubMed, Rheumatology (Oxford)) - "Biologics targeting IL-1, IL-6, IL-17, and IL-12/23 pathways may offer therapeutic alternatives in BD patients unresponsive to TNF-α inhibitors. The treatment efficacy varies across phenotypes, highlighting the need for individualized treatment decisions."

Journal • Ankylosing Spondylitis • Immunology • Musculoskeletal Diseases • Rare Diseases • Seronegative Spondyloarthropathies • Spondylarthritis • IL12A • IL17A • IL6

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