Roche Taishengqi® immune combination therapy program approved in China for the treatment of hepatocellular carcinoma

On October 28, 2020, Roche announced that China's State Drug Administration (NMPA) had approved its cancer immuno-innovative drug Atiliju monoanti (trade name: Tai Sanqi ®, Tecentriq®) to treat patients with non-excisible hepatocellular carcinoma (HCC) who had not previously received systematic treatment.
was based on the results of phase III clinical trial IMbrave150, which included an analysis of 194 Chinese sub-group patients.
primary liver cancer is the 4th most common malignant tumor and the 2nd cause of tumor death in China.
Chinese accounts for only 18.4% of the world's population, but each year new cases of liver cancer account for 55.4% of the world's total, and 53.9% of deaths worldwide, equivalent to more than 1,000 patients diagnosed with liver cancer every day, of which HCC accounts for 85% to 90%.
, the five-year survival rate of Chinese patients is only 12.2%, and people's lives and health are seriously threatened by liver cancer.
study showed that the combination therapy significantly reduced the risk of death and disease progression and risk of death compared to standard treatment, and that patients reported better quality of life and deterioration of function than standard therapy.
group IMbrave150 study in China were consistent with global results.
safety of the "T-A" is consistent with previously known safety characteristics of individual medications, and no new safety signals have been detected.
results were published in the New England Journal of Medicine on May 14, 2020.
recent years, more and more clinically urgently needed innovative drugs have been introduced to China more quickly, benefiting more Chinese patients, driven by a deepening drug review and approval system.
, China's State Drug Administration granted priority review qualifications for "T-A" combination therapy for first-line treatment of late-stage non-removable hepatocellular carcinoma.
May, the U.S. Food and Drug Administration approved a combination of "T-A" therapies for the treatment of non-removable or metastatic hepatocellular carcinoma patients who had not previously received systematic treatment.
, there are a number of domestic and foreign clinical guidelines to "T-A" as the first-line treatment of advanced hepatocellular carcinoma priority recommended therapy.
Professor Qin Shuxuan, lead Chinese researcher on the IMbrave150 study and chairman of the Committee of Experts on Liver Cancer of the Chinese Society of Clinical Oncology, said: "Unlike liver cancer in Europe and the United States, about 77% of liver cancer in China is caused by the hepatitis B virus (HBVV) Infection, and has the characteristics of basic liver disease, hidden disease, symptoms are not typical, treatment is difficult, poor prognosis and so on, most patients are in the middle and late stage of diagnosis, lost surgery or other local treatment opportunities;
, there is an urgent need for effective innovative drugs and treatments to break through.
the 'T-A' immunotherapy has a completely new mechanism of action, through large-sample clinical trials have fully demonstrated that first-line therapy can significantly reduce the risk of death in patients with advanced non-surgical excision of hepatocellular carcinoma, and significantly improve the quality of life.
, the Chinese sub-group of 194 Chinese patients in the IMbrave150 trial and the extended trial produced better data results than the global population.
this important breakthrough of the joint treatment drugs / program was finally approved in my, from then on will benefit the vast number of liver cancer patients, really is gratifying! Zhou Hong, President of Roche Pharmaceuticals China, said, "The combination therapy of 'T-A' has received widespread attention and recognition as a new treatment with transformative significance in the treatment pattern of liver cancer.
TaiSage® Hepatocellular Carcinoma Adaptive Disease has been approved in China to provide new treatment options for patients who unfortunately develop this type of aggressive cancer and currently have limited treatment options to better meet the unfinished needs of the liver cancer treatment field.
At the same time, with an innovative portfolio from diagnosis to treatment, Roche also hopes to work with partners in a variety of areas, including disease cognition, diagnostic testing, treatment and monitoring, to curb the spread of chronic liver disease and ultimately achieve the goal of preventing and curing hepatocellular carcinoma.
"Tai Sanqi® is a monoclonal antibody designed to bind directly to PD-L1 ligation proteins expressed directly on tumor cells and tumor-immersed immune cells, blocking their interaction with PD-1 and B7.1 receptors.
by blocking the PD-L1 path, T-® can effectively activate T cells.
as an innovative cancer immunotherapy treatment, Tysantsch® is expected to be used as a base drug for combination therapy, in combination with other immunotherapy, targeted drugs and various chemotherapy drugs for the treatment of a variety of cancers.
Roch has developed an extensive development program for Tysanci® (Atili-Juju monotherapy), which includes a number of ongoing and planned Phase III studies covering lung cancer, reproductive urinary system tumors, skin cancer, breast cancer, digestive tumors, gynaecological tumors and head and neck cancers, including studies aimed at evaluating Tesantsch®s monotherapy and immunotherapy with other drugs.
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