Professor Zhou Cun: GemStone-302 Research Update, Schogly Mummy has strong and secure coexistence |
Author:Cancer Channel of the Medical Time:2022.06.10
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Listen to Professor Zhou Cun's latest data from Gemstone-302 and Schoglyab Features.
lung cancer is the second largest malignant tumor globally, and it is also one of the most common causes of malignant tumors to death. 80%~ 85%of primary lung cancer are non -small cell lung cancer (NSCLC), and most of them are in advanced disease at the time of diagnosis, and have lost their chances of surgery. With the continuous release of immune new drugs and related clinical studies, immunotherapy has completely changed the treatment of lung cancer. In December 2021, based on the results of the Gemstone-302 research, Schurge Mutterum was approved by the first-line treatment for patients with advanced NSCLC in China. In 2022, the results of the Gemstone-302 research on the Annanian Society of the United States Clinical Oncology (ASCO) Conference confirmed the excellent clinical efficacy of Schogly MeticidalThe main study of Gemstone-302 research in the medical circles of the medical community Professor Zhou Cun, Shanghai Lung Department, interpret the research data and drug characteristics and share his academic insights.
Gemstone-302 Study Study :
The clinical design of innovation brings excellent clinical efficacy
Gemstone-302 Study is a multi-centered, random, and double-blind phase III clinical trial. Anti -combined chemotherapy comparative placebo combination of chemotherapy, the effectiveness and safety of unprecedented, IV -stage NSCLC patients. This study is the first III clinical trial that China has covered scales and non -scale first -centered NSCLC patients at the same time. It is not only under the current treatment situation, but also in line with medical ethics, while saving a lot of R \u0026 D costs and research time. In 2022, the ASCO conference announced the overall survival (OS) mid-term analysis data of Gemstone-302 research:
As of November 22, 2021, 51 and 7 of all 479 patients were included in the group. For example, patients are still receiving the treatment of Schogly Micometer combined with chemotherapy or placebo. The mid -range follow -up time of the Schurli Meticuke and the placebo group was 25.4 months and 24.9 months, respectively. The median OS of the Schurli single resistance group is 25.4 months, the median OS of the placebo group is 16.9 months, HR \u003d 0.65; the 2 -year OS rate is 51.7%and 35.6%, respectively. OS benefits are observed in all sub-groups including different tumor tumors and PD-L1 expression levels.
Among the people who care about the treatment of the crowd, the median of the Schogly Single Anti -Group is not progressingThe storage period (PFS) was 9.0 months, while the comfort group was 4.9 months (HR \u003d 0.49), and the 2 -year PFS rate was 20.8% VS 7.3%, respectively. The Asian group analysis showed that among patients with PD-L1 ≥ 1%, the median PFS of the two groups was 10.9 months VS 4.9 months (HR \u003d 0.48). Among the patient metastasis patients, compared with the placebo group, Schutery Mippling improved the patient's OS (HR \u003d 0.45) and PFS (INV-PFS, HR \u003d 0.33) evaluated by the patient's intracranial researcher. The results of security are consistent with the results of previous reports.
The HR of Schogley Midella is relatively low,
Prefer to treat scerm carcinoma
Different clinical research data often has a large difference in baseline characteristics, and it is inevitable that it is inevitable Data is deleted. HR duty is less affected by data structure and maturity, comprehensive and stable, and can fully reflect the overall treatment effect during the treatment and follow -up. Professor Zhou Cun said that by indirect comparison of the research of the same type of immunotherapy, the minimum HR of Schgley Midelia was found to have a significant effect on patients with squamous and non -squamous carcinoma. What's more worth mentioning is that the advantages of Schurge Micometer's combined chemotherapy on lung \u0026 squamous carcinoma are more obvious. They are 8.3 months VS 4.8 months, and HR is as low as 0.34, which is significantly reduced by 66%of the progress of disease and death [2].
Although there is no head -of -head comparison data at present, Schogly Micometer's combined chemotherapy scheme is not worse than other immunohistochemical point inhibitors. The Schurli Meticuke Joint Plan is expected to become a new standard of first -line therapy for patients with advanced NSCLC. In particular, patients with squamous carcinoma can give priority to the Schurley Meticuke joint scheme.
The efficacy originated from the drug design:
The unique machine manufacturing of the Schogley Midtoch is extraordinary efficacy
The clinical effect of the excellent clinical efficacy of Shogley Metarius originated from its unique efficacy In the mechanism, Professor Zhou Cun pointed out that Schurli Mipoly is a natural G -type immunoglobulin 4 (IGG4) monoclonal anti -anti -anti -anti -anti -anti -anti -anti -anti -anti -anti -anti -anti -anti -anti -anti -anti -antidote drug, which has uniquely retained the FC segment so that it can be combined with the FC γ receptor on the surface of the macrophage to mediate and mediates The tumor cells of PD-L1 in macrophages express PD-L1, that is, the phagocytosis (ADCP) of antibody-dependent cells is produced. It has upgraded the efficacy of the effect of maintaining the good safety of the PD-L1 inhibitor. In addition, Schurli Micide also avoids cytotoxic effects (ADCC) that antibody -dependent cell -dependent cells dependent. As a monoclonal resistance of PD-L1, Schurli Monopoly only blocks the combination of PD-1/PD-L1 to retain the combination of PD-1/PD-L2, reducing its own attack on the human body's high expression of PD-L2, so The incidence of adverse incidents of immunity is relatively low.
Therefore, based on the unique pharmaceutical design and efficacy mechanism of Schogly Mupping, it can play a strong and safe role in clinical practice, and it is a late NSCLC suffer fromThe new choice of high -efficiency and low toxicity is expected to reshape the NSCLC's treatment pattern. It is expected that pharmaceutical companies will strengthen investment in the future and carry out more research mechanisms to continue to explore Schogly Midumi.
Expert Introduction
Professor Zhou Cun
Professor: Chief physician, professor, doctoral supervisor, enjoy the special allowance of the State Council;Unit: Shanghai Lung Department, Affiliated to Tongji University, Institute of Cancer Research Institute of Tongji University School of Medicine
CSCO Society: Executive Member
Other Society's position:
International Core member of the Board of Directors of the Lung -Cancer Association (IASLC)
CSCO non -small cell lung cancer special committee chairman
Chairman of the Chinese medical association chest tumor branch
Shanghai anti -anti Cancer Association's Chairman of the Council of Pulmonary Cancer Molecular targeted and immunotherapy
Leader of China East and West Lung Cancer Research Cooperation (E-WEST)
Committee
The chairman of the Cancer Clinical Research Committee of the China Anti -Cancer Association
Member of the Education Commission of the International Lonion Cancer Research Association (IASLC)
IASLC Research Association (IASLC ) Member of the tobacco control committee
Good -looking field/long -term engaging in: accurate treatment of lung cancer, lung cancer immunotherapy, early diagnosis of lung cancer, lung cancer transformation research
Main achievements: Shanghai leading talent, Shanghai regaining middle school The person in charge of the key discipline of respiratory diseases has been funded by various scientific research projects, including the National 863 Plan, and the National Natural Science Foundation of China. Lead or participate in more than 30 large -scale clinical research, including Optimal, Beyond, etc.
Article: Published more than 200 articles, Lancet Oncology, JCO, Lancet Respiratory, Annals of Oncology, JTO, IJC, Cancer et al.
Award: National Science and Technology Progress Award, Shanghai Science and Technology Progressive prize, the first prize of the China Anti -Cancer Association Science and Technology, the first prize of the Huaxia Medical Science and Technology Award, the first prize of the Shanghai Medical Science and Technology Award, Shanghai Good Doctor
References:
[ 1] Wang Yong. In advanced non -small cell lung cancer (NSCLC) targeted therapy two or three things [j]. Health must read, 2020, (21): 229.
[2] zhou c, Wang Z, Sun y, et al. MA13.07 Gemstone-302: A Phase 3 Study of Platinum-BasedChemotherapy with Placebo or Sugemalimab, A PD-L1 Mab, for Metastatic NSCLC [J]. Journal of Thoracic Oncology, 2021, 16 (10): S926-S927.
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