Ilaris (canakinumab)

These findings underscore significant safety signals associated with canakinumab, including infections, gastrointestinal/hepatobiliary disorders in children, and neoplasms in older patients. The dual temporal pattern of AEs underscores the need for both short- and long-term surveillance.

P1, N=17, Completed, Columbia University | Active, not recruiting --> Completed

P2, N=120, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting

P=N/A, N=160, Not yet recruiting, Novartis Pharmaceuticals

P=N/A, N=5000, Recruiting, Duke University | Trial primary completion date: Sep 2026 --> Mar 2027

P1, N=9, Active, not recruiting, NYU Langone Health | Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Jul 2026

Therapeutic blockade of the IL-1 pathway with agents, such as anakinra, canakinumab, or rilonacept, reduces tumor growth, metastasis, and immune suppression in preclinical PDAC models. Summarily, IL-1R1 is a central driver of PDAC aggressiveness and a therapeutic target. Targeting this pathway may enable biomarker-guided strategies to improve outcomes in this disease.

Pharmacological agents like metformin, SGLT2 inhibitors, and statins demonstrate promising anticancer effects in addition to glycemic control, while biologics such as canakinumab and tocilizumab modulate inflammatory processes relevant to both disease states. Ultimately, dual-targeting strategies represent an emerging and promising therapeutic framework for managing patients with overlapping cancer and metabolic disease, with potential to optimize outcomes, reduce therapy-related toxicities, improve long-term survival. Future research must prioritize biomarker-guided precision therapies, multidisciplinary management and the inclusion of metabolic parameters in oncology trial designs.

P3, N=673, Terminated, 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

In this pediatric cohort of cr-FMF patients, both anakinra and canakinumab were effective in reducing disease activity and inflammation. Anakinra offered rapid symptom relief but had frequent injection site reactions. Canakinumab provided sustained control with fewer local side effects but required monitoring for rare complications.

P3, N=673, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2027 --> May 2026

IL-1 inhibitors, such as anakinra, rilonacept, and canakinumab, have been introduced as adjunctive treatments...The control group consisted of patients receiving colchicine treatment only...However, differences were noted in FSH, total testosterone, and GH levels, with higher FSH and GH in the control group and higher testosterone in the experimental group. Although IL-1 plays a role in hormone secretion pathways, further studies are needed to better understand the effect of IL-1 antagonists on pituitary function, as no significant adrenal or pituitary insufficiencies were observed.