May 23, 2024

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Novartis Iscalimab for kidney transplantation: less effective than Tacrolimus!

DrNovartis Iscalimab for kidney transplantation: less effective than Tacrolimus!

Novartis Iscalimab for kidney transplantation: less effective than Tacrolimus!

Novartis terminates the Phase 2 study of CD40-targeted monoclonal antibody iscalimab in kidney transplantation: less effective than tacrolimus!

Novartis recently announced that it has decided to terminate the study after conducting an interim analysis of data from the Phase 2 CIRRUS-1 study (NCT03663335) of CD40-targeted monoclonal antibody CFZ533 (iscalimab) for the treatment of kidney transplant patients.

Analysis shows that compared with tacrolimus-based treatment, CFZ533-based treatment is less effective in preventing organ rejection in kidney transplant patients. In this study, both CFZ533 and tacrolimus were used in combination with other immunosuppressive therapies (induction therapy, mycophenolate mofetil and corticosteroids). Tacrolimus is a calcineurin inhibitor (CNI) and an immunosuppressant commonly used in kidney transplant patients and some kidney disease patients.

The CIRRUS-1 study evaluated 418 transplant patients and studied 3 different doses of CFZ533, aiming to evaluate the ability of CFZ533 to replace calcineurin inhibitor (CNI) in anti-rejection, while providing better renal function and Better safety and tolerance.

Novartis is continuing to review the data from the CIRRUS-1 study. Once completed, the results will be shared with the wider scientific community. Currently, research on CFZ533 in liver transplantation is still ongoing, and research to explore CFZ533 as a potential therapy for other diseases is also underway, such as hidradenitis suppurativa and Sjögren syndrome.


It is estimated that approximately 3.2 million people worldwide suffer from end-stage renal disease (ESRD) and require kidney transplantation. Studies have shown that less than 50% of donated kidneys can survive in transplant recipients for 10 years. Therefore, for patients undergoing or waiting for transplantation, the long-term survival of donated kidneys is a major unmet medical need. Any treatment that can prolong the life of a donated kidney will have a major impact on the availability of transplant recipients and donor organs.

CFZ533 (iscalimab) is a new, fully human monoclonal antibody that targets cluster of differentiation antigen 40 (CD40). It can regulate the CD40-CD154 costimulatory pathway and prevent CD40 pathway signal transduction and CD40+ cell type activation. It is expected to be a therapeutic New treatments for solid organ transplant rejection and related autoimmune diseases.

In June 2019, Novartis announced the early histological data of CFZ533 in kidney transplantation, indicating that CFZ533 may be more effective than tacrolimus, may be able to extend the durability of transplanted kidneys and potentially improve the long-term prognosis of kidney transplant patients.

The analysis showed that 60% of kidney transplant patients treated with CFZ533 had normal kidney histology at least one year after transplantation, while this proportion was 0 in patients treated with tacrolimus.

(source:internet, reference only)

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