GNT Biotech & Medicals Corporation has obtained approval for Tucidinostat, a new drug for treating breast cancer. Its potential in the treatment of advanced cancers has been recognized once again. In a randomized phase II clinical trial initiated by clinical researchers supported by partners, using Tucidinostat in combination with anti-PD-1 Ab + Bevacizumab (referred to as the Tucidinostat triplet combination) to treat patients with advanced colorectal cancer (MSS/pMMR) yielded excellent results, with an ORR (objective response rate) of 44% and a median PFS (progression-free survival) of 7.3 months. These results have been published in the globally renowned medical journal Nature Medicine in March.
Tucidinostat, a drug under GNTbm, obtained the first domestic oral drug certificate for breast cancer in June of 2023. It continues to invest more research and development resources to expand the indications for Tucidinostat, including late-stage liver cancer, advanced colorectal cancer (MSS/pMMR), diffuse large B-cell lymphoma, and peripheral T-cell lymphoma, aiming to help more cancer patients.
Colorectal cancer is the second most prevalent and the third deadliest cancer in Taiwan. Among them, the [(microsatellite stable, MSS; mismatch repair-proficient, pMMR)] type accounts for about 90% of all colorectal cancers. When patients progress to the advanced stage (inoperable), the choice of effective drugs for treatment is very limited, and there is a strong demand for unmet clinical needs. Every year, 6-7 thousand people in Taiwan die from advanced colorectal cancer.
GNTbm pointed out that Tucidinostat's potential in the treatment of advanced cancers has achieved crucial breakthrough clinical results in trials initiated by clinical researchers supported by partners. In a randomized phase II clinical trial using Tucidinostat in combination with triplet drugs to treat patients with advanced colorectal cancer (MSS/pMMR), these patients, who have received at least second-line systemic therapy, achieved very impressive results. The ORR was 44%, the mPFS was 7.3 months, and the mOS has not yet been reached (observed for a median of 19 months). These results have been published in the globally renowned medical journal Nature Medicine (doi: 10.1038/s41591-024-02813-1) in March.
Currently, drugs used for third-line treatment of advanced colorectal cancer (MSS/pMMR) worldwide include Regorafenib, Lonsurf, Lonsurf + Bevacizumab, and Fruquitinib, among others, with an mOS of no more than 1 year (6.4-10.8 months). GNTbm stated that the Tucidinostat triplet combination has the potential to significantly prolong mOS. The ORR of these previous drugs was also very low, making it difficult to shrink tumors significantly. The Tucidinostat triplet combination achieved an ORR of 44%, meaning that 44% of patients' tumors will significantly shrink. The mPFS of Regorafenib and Lonsurf currently used in Taiwan's National Health Insurance is not long, about 1.9 months. The Tucidinostat triplet combination achieved an mPFS of 7.3 months, indicating a significant extension of the time when patients' diseases are controlled. Many patients with advanced colorectal cancer (MSS/pMMR) will have liver metastasis, reducing the efficacy of tumor immunotherapy. However, the Tucidinostat triplet combination does not reduce the efficacy of treatment in such patients.
Advanced colorectal cancer (MSS/pMMR) belongs to "cold tumors," meaning that CTL immune cells are difficult to attract to infiltrate the tumor microenvironment, but it attracts a large number of inhibitory immune cells (Treg, MDSCs, TAM) to infiltrate the tumor microenvironment, forming an immunosuppressive environment or "immunological desert." The main function of the Tucidinostat triplet combination is to reshape the tumor microenvironment, transforming the original "cold tumor" into a "hot tumor," achieving unprecedented excellent treatment benefits, which belong to tumor immunotherapy.
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