Immunomedics' ADC drug Triple Negative Breast Cancer III was successful

April 6, Immunomedics announced the early termination of its Phase III ASCENT study on the treatment of metastasis triple-negative breast cancer (TNBC) with its ADC drug sacituzumab govitecan, as recommended by the Independent Data Monitoring Board.The ASCENT study aims to assess the efficacy and safety of sacituzumab govitecan for the treatment of metastasis triple negative breast cancer. The main endpoint is no progress survival, the secondary end point includes the total survival rate and objective response rate.The FDA has accepted applications for listing of the drug from Immunomedics on July 18, 2018 and granted priority review eligibility. However, the listing application was temporarily rejected on 1/17/2019 due to chemical, production and control issues. On December 26, 2019, Immunomedics' re-filed application for the drug's listing was accepted by the FDA on PDUFA date of 2020/6/2. Previously, the FDA has awarded the drug breakthrough therapy and fast-track qualification for the treatment of triple-negative breast cancer.TNBC is an invasive disease that accounts for 12-20% of all breast cancers, as estrogen-infusions (ERs), progesterone-like bodies (PR) and human skin growth factor 2 (HER2) are all negative expressions; hair and metastasis; insensitive to hormone therapy and targeted therapies such as Hessetin), the treatments available are almost only chemotherapy, but most patients develop resistance quickly and have poor prognosis, and if they spread to other parts of the body, the survival period is usually only 12-15 months, so there is an urgent need to develop new and effective treatment strategies.Sacituzumab Govitecan is a combination of the humanized monoclonal antibody hRS7 IgG1 and the cytotoxic compound SN-38, which targets Trap-2. Trop-2 is an overexposed trans-membrane calcium signaling sensor in a variety of epithelocytic cell carcinomas that stimulates cancer cell growth. The protein has a 90 percent expression rate in TNBC patients. SN-38 is a metabolite of the chemotherapy drug irinotecan, a topological isomer I inhibitor that can kill tumor cells. When the antibody hRS7 binds to Trap-2 on cancer cells, high concentrations of SN-38 can be delivered directly to tumor cells. (Medical Rubik's Cube)