ASCO2020 , new breakthrough in immunotherapy for lung squamous cancer, Baiji Shenzhou shows the value of China's "research"

May 29, 2020, the annual event of the global oncology community - the Annual Meeting of the American Society of Clinical Oncology (ASCO) officially opened, China's local biopharmaceutical company Baiji Shenzhou at this year's ASCO annual meeting in an oral report and three posters to announce its anti-PD-1 antibody drug Baczean ® (generic name: Tirelli bead monoantigen injection) and BTK inhibitor BRUKINSatM (Zebini) clinical dataAmong them, The data of Phase 3 clinical trial (Rationale-307 study) for the treatment of patients with first-line squamous non-small cell lung cancer ("Lung squamous cancer") are published for the first time, which is the first successful first-line immunotherapy phase 3 clinical study in China, and the first successful phase 3 study in China in the fieldherds of stags, focusing on the rise of Chinese groups of immuno-cancer drugs
in recent years, the incidence of lung cancer in China has been increasingIn 2018, there were about 770,000 new cases of lung cancer and about 690,000 deaths in the countryAs the leading cause of cancer-related death in China, lung cancer has been the focus of global and local pharmaceutical companiesIt is understood that in 2019 the domestic cancer clinical trials involved in 335 drug varieties, lung cancer-related drugs, about 23.3%, ranked firstAlthough a large number of clinical studies are being advanced, there have been limited treatments in the field of lung squamous cancerLung squamous cancer accounts for nearly 30% of non-small cell lung cancer (NSCLC) cases, but due to the significantly low proportion of driving gene mutations, patients with advanced pulmonary squamous cancer have long been unable to have suitable targeted drugs and rely mainly on chemotherapyProfessor Wang Jie, Director of the Oncology Hospital of rationale-307 research and the Chinese Academy of Medical Sciences, said: "For more than 10 years, the treatment of patients with squamous cancer has lagged behind the treatment of patients with lung adenocarcinoma, and there is no suitable targeted treatment drug optionThe emergence of immunotherapy has changed this stateInternationally, the KEYNOTE-407 study (PD-1 inhibitor Pablo Pearl mono-anti-chemotherapy) has obtained positive data, but in this study of China's extended study, the Chinese group has only 125 cases, the sample size is relatively small, so there is an urgent need for a large-scale, for Chinese group of lung squamous cancer patients clinical research, in this context, by the local enterprise Baiji Shenzhou independently developed anti-PD-1 antibody drug Baizean ® (The Reilly Pearl monolith) "
Rationale-307 study is a randomized, multi-center, open phase 3 clinical study for patients with first-stage pulmonary squamous cancer, and consists of three therapeutic groups: two therapeutic groups (including the Terelli Pearl mono-anti-co-purple rosinol-caplatinum treatment group and the Terri-Rey-Single Anti-Co-albumol-Caplatinum Treatment Group) compared to the simple chemotherapy group (sequoia-caratherapy group)According to data released at the ASCO meeting, the main endpoint of the study, PFS (No Progress Time), achieved positive results, with a significant improvement in PFS in patients and a 52% reduction in the risk of disease progression In addition, the objective remission rate was more than 70% in the combined therapy group, nearly 25% higher than in the chemotherapy group, and the duration of remission in the combined therapy group was more than 8 months Professor Wang Jie said: "These data show that in the treatment of patients with lung squamous cancer, the treatment of Drelizumab-combination chemotherapy has significantly improved compared to the simple chemotherapy regimen, and this result is clinically instructive." "It is reported that the application for new indications for treating patients with first-line advanced lung squamous cancer has been accepted by the State Drug Administration (NMPA) comprehensive layout, for domestic lung cancer patients to bring a new dawn of treatment
According to the previously published data, according to the current research in the field of non-small cell lung cancer comprehensive coverage of squamous and non-squamous cancer, in addition to the 307 research published scale cancer results, the combination of darellizumab monoantigen The Rationale-304 study on the first-line treatment of advanced non-squamous cancer patients of chemotherapy was also announced in April this year to reach the main endpoint, which means that Terrei Pearl is the first Chinese-developed anti-PD-1 antibody drug to be fully developed in China to achieve the successful first-line registered clinical study of advanced squamous cancer and non-squamous cancer in addition to the 307, 304 study, the global multi-center 3 registered clinical study (Rationale-303 study) for patients with advanced second/third-line NSCLC treatment of Terrey Pearl single-drug monodruga treatment has completed global patient intake, and clinical research (Rationale-312) for patients with a wide range of small cell lung cancer (SCLC) patients in the first-line small cell lung cancer (Rationale-312) has been completed globally "The Rationale-307 study is the first successful clinical study in China for the first phase of the first-stage clinical study for the treatment of advanced squamous cancer in China, and is the only large-scale clinical study with the largest sample size to publish research data, including 360 Chinese patients, of whom 239 patients received treatment for the combination chemotherapy program." This provides important guiding significance for the clinical practice of immunotherapy in patients with lung squamous cancer in China Professor Lu also served as lead PI in the Rationale-304 study of Baiji Shenzhou In his opinion, Baiji Shenzhou's Treli Zhu dan resistance can be in the scale cancer and non-scale cancer two first-line clinical research results have been positive results, is very proud of the results, but also reflects the advanced research and development technology and concepts of Baiji Shenzhou Terri Josie is the world's first immuno-oncology treatment drug, approved in December 2019 in China, has been approved for recurrent/ incurable classic Hodgkin lymphoma and local late or metastatic urinary disease treatment Unlike other anti-PD-1 antibody drugs, Terrey Zumai has been genetically engineered to optimize the Fc segment of the antibody, minimizing the binding to Fc'r in macrophages, thus eliminating the cell-mediated phagocytomy (ADCP) of antibody dependence, reducing T-cell consumption and increasing anti-tumor activity The antigen binding epitope, which is unique to the terelli bead monoantigen, overlaps the binding surface on PD-1 with the PD-L1 of the tumor, and can more widely block the binding of PD-1 and tumor PD-L1, and has a higher affinity it is understood that at present, The Telli-Zhu dan resistance is in 23 countries and regions around the world to carry out 15 registered or potential registered clinical trials, of which 11 are 3 clinical trials, covering lung cancer, liver cancer, esophageal squamous cell carcinoma, stomach cancer and other high-risk cancer species, a total of more than 5000 patients into the group With differentiated product design and excellent clinical performance, Baiji Shenzhou is accelerating the expansion of terrei Zuma's indications for solid and blood tumors through a series of clinical trials of monotherapy and combination therapies