89% Complete Response Rate Achieved with Oncolytic Virus CG0070 and Keytruda Combination in Phase 2 Trial for BCG-Unresponsive NMIBC

Today, CG Oncology announced that its oncolytic virus therapy CG0070, in combination with MSD's anti-PD-1 antibody Keytruda, achieved positive interim results in a Phase 2 clinical trial for the treatment of non-muscle invasive bladder cancer. These patients did not respond to BCG treatment. The interim results showed that three months after treatment, among 18 evaluable patients, the combination therapy achieved an 89% complete response rate. Notably, this innovative therapy has also been approved for clinical trials in China, with Lepu Biopharma holding the development rights in China.

Oncolytic viruses are a class of viruses that can selectively lyse cancer cells. They can infect tumor cells and cause cell lysis, and the molecules released during the lysis process can induce innate and adaptive immune responses, attracting more immune cells to continue killing residual tumor cells. In addition, many oncolytic viruses can also carry therapeutic transgenes to enhance anti-tumor efficacy.

CG0070 is based on a modified adenovirus type 5 (Ad5) backbone, including a tumor-specific promoter and a granulocyte-macrophage colony-stimulating factor (GM-CSF) transgene. After lysing tumor cells, GM-CSF is released along with tumor-specific antigens and other danger signals. GM-CSF can activate dendritic cells (DC), which recognize tumor antigens and present them to cytotoxic and helper T cells, thereby promoting their maturation. These T cells can then circulate throughout the body, identifying and attacking residual tumor cells.

▲Mechanism of Action of CG0070 (Image Source: CG Oncology Official Website)

The latest data presented at the AACR Annual Meeting showed that 85% (n=13) of patients maintained complete remission for more than 6 months, 78% (n=9) maintained complete remission for over 9 months, and this figure was 75% (n=8) when assessed after 12 months of treatment.

"These interim results continue to support the potential of CG0070 in treating BCG-unresponsive bladder cancer patients," said Arthur Kuan, CEO of CG Oncology. "As this study approaches completion, we look forward to continuing to observe positive outcomes from the combination of CG0070 and Keytruda."

References:

[1] CG Oncology Presents Interim Phase 2 Data with CG0070 in Combination with KEYTRUDA® (pembrolizumab) in Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin. Retrieved April 13, 2022, from https://www.businesswire.com/news/home/20220413005043/en

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