Three months after it was approved, the world's first ADC to treat triple-negative breast cancer has finally revealed the results of the phase 3 study.

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July 8, 2020 / emedclub news / - April 22, 2020, antibody coupled drug (ADC drug) trodelvy (sacituzumab govitecan hziy) of immunomedics Co., Ltd, Immu-132) has been approved by FDA to treat patients with metastatic triple negative breast cancer (mtnbc) who have received at least two previous treatments.recommended reading: FDA has approved the first ADC drug for metastatic triple negative breast cancer, and the efficacy of ADC drug for metastatic triple negative breast cancer is outstanding. Immunomedics shares have soared with a market value of more than $4 billion. It is reported that trodelvy's approval is based on the positive results of its phase 3 confirmatory study called ascent.two weeks before approval for listing, immunomedics chose to terminate the ascent study ahead of time on the recommendation of the independent data Oversight Committee (DSMC). But what data led the DSMC to make such a recommendation? Dr. Behzad Aghazadeh, executive chairman of immunomedics, also commented at the time: "we do not know the full content of their decision, but it is clear that the trial has reached the main end point."three months later, immunomedics finally released the results of ascent, including progression free survival (PFS) and overall survival (OS).excellent trial data the ascent trial was designed to verify the safety and efficacy of trodelvy in the treatment of mtnbc patients who had received various pre treatments.the primary endpoint of the study was progression free survival (PFS), and the secondary endpoints included overall survival (OS) and objective response rate (ORR).the newly published data show that the primary end point of progression free survival (PFS) has been reached, and the key secondary endpoint has also been achieved; the median PFS of patients in trodelvy treatment group is 5.6 months, and that of chemotherapy group is 1.7 months. Br / > the most common adverse events of < 3 grade neutropenia or neutropenia observed by the US FDA were consistent with the safety level of < 3.the prescription information for trodelvy includes a black box warning that the drug may cause severe neutropenia and severe diarrhea, but there are no treatment-related deaths, no severe neuropathy or interstitial lung disease.it was pointed out in the press release that the full results of the experiment will be published at a medical conference in the near future.lead researcher, Dr. Aditya Bardia, associate professor of breast cancer center, mass cancer center and medicine at Harvard Medical School, said: "the results of the global phase 3 ascent study confirm our preliminary observation that trodelvy has the potential to change the standard treatment of mtnbc.based on these data, trodelvy provides a new benchmark of scientific and clinical innovation for mtnbc patients, and provides a novel alternative method for common drugs in current clinical practice.importantly, the main data of ascent also verified the safety and easy management of sacituzumab govitecan, making it a combination therapy combined with other therapies, including immunotherapy."in addition, trodelvy, as the first approved third line ADC drug for adult patients with mtnbc, is currently undergoing clinical trials in China.on April 21, according to the official website of the drug evaluation center (CDE) of China's State Drug Administration, the drug was approved for a clinical trial in China. The indication is: metastatic triple negative breast cancer who has received at least two lines of previous treatment. The application was submitted by Everest.strong sales potential of trotelvy. Prior to the release of the trial data, although investors were optimistic about the treatment and immunomedics, as Cowen analyst Phil Nadeau commented, "investors underestimated trotelvy's sales potential.".analysts believe that trodelvy will be rapidly used as the standard treatment for recurrent / refractory mtnbc, and will generate $1 billion in global revenue by 2025.however, this does not take into account the potential of trotelvy in ER + / HER2 metastatic breast cancer or urothelial carcinoma. Given the data from ascent, troldvy also has sufficient potential. ▲ Shares of immunomedics (image source: finance.sina ）On the day of the data release, the shares of immunomedics rose 3.09% to $40.63 per share. In fact, since trodelvy was approved for listing in April, the company's stock has been on the rise, with a market value of about $4 billion in April to $9.381 billion today, which is not far from breaking the $10 billion mark. focusing on four popular biomedical fields, such as tumor immunity, new antibodies, stem cell regenerative medicine and gene therapy, the 2020 bpit biopharmaceutical innovation technology conference will be held in Nanjing International Youth Culture Center, China, on July 19-21, 2020! Click the picture above to view the agenda of the conference