Drug intelligence / Profile preview

cretostimogene grenadenorepvec + pembrolizumab

Development stage
Phase 2
Lead developer
CG Oncology
Modality
Oncolytic Viruses → Oncolytic Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravesical, Intravenous
01

Overview

Cretostimogene grenadenorepvec + pembrolizumab is a combination therapy under investigation for the treatment of Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC), particularly in patients with carcinoma in situ (CIS). Cretostimogene grenadenorepvec is an intravesically delivered oncolytic immunotherapy based on a type 5 adenovirus engineered to selectively replicate in bladder cancer cells with alterations in the retinoblastoma pathway. It also expresses the GM-CSF transgene, promoting tumor cell lysis and stimulating a systemic anti-tumor immune response through immunogenic cell death and antigen release. Pembrolizumab is a monoclonal antibody targeting PD-1, blocking its interaction with PD-L1/PD-L2 to enhance T-cell mediated anti-tumor activity. The combination has shown high complete response rates and durable responses in phase 2 trials, with no progression to muscle-invasive or metastatic disease observed during follow-up[1][3][5].

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Targets

CXADR (Coxsackievirus and adenovirus receptor)PDCD1 (Programmed cell death protein 1 receptor)GM-CSF (Granulocyte-macrophage colony-stimulating factor)Retinoblastoma Pathway-Altered Tumor Cell

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