Drug intelligence / Profile preview

durvalumab + BCG

Development stage
Unknown
Lead developer
AstraZeneca
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous, Intravesical
01

Overview

**Durvalumab + BCG** is a combination therapy consisting of **durvalumab**, a human IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), and **BCG (Bacillus Calmette-Guérin)**, a live attenuated strain of Mycobacterium bovis used as an intravesical immunotherapy. Durvalumab inhibits PD-L1, enabling T-cell activation and anti-tumor responses; BCG stimulates a localized immune response in the bladder mucosa, inducing a broad inflammatory milieu that targets tumor cells. This combination is being developed to enhance the immune-mediated eradication of **non–muscle-invasive bladder cancer (NMIBC)**, particularly in high-risk or BCG-unresponsive settings. Recent phase 1 and phase 3 trials demonstrate that co-administration is feasible and safe, with preliminary data suggesting an improved complete response (CR) rate and disease-free survival (DFS) compared to BCG alone. The main ongoing development is for high-risk NMIBC, both BCG-naive and BCG-unresponsive populations[1][2][3][4][6].

Brand names
Imfinzi
Other names
Bacillus Calmette-GuérinBacillus Calmette-Guerindurvalumab plus BCG
02

Targets

CD274 (Programmed cell death protein 1 ligand 1)

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