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    Home > Active Ingredient News > Blood System > 2021 CSCO WuXi Juno Satellite Symposium: Based on China, forging ahead, Benoda® helps patients benefit from long-term survival

    2021 CSCO WuXi Juno Satellite Symposium: Based on China, forging ahead, Benoda® helps patients benefit from long-term survival

    • Last Update: 2021-10-11
    • Source: Internet
    • Author: User
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    In recent years, Chimeric Antigen Receptor T Cell Therapy (CAR-T), as a new method of tumor treatment, has achieved surprising results in hematological tumors, and CAR-T-related new drugs have been listed in the country one after another
    .

    As a leading cellular immunotherapy company, WuXi Biopharmaceuticals has launched China's first CAR-T therapy approved for Category 1 biological products-Benoda® (Rigid Orenza Injection)
    .

    During the 2021 CSCO conference, WuXi Junuo hosted a CAR-T special satellite conference.
    Professor Shen Zhixiang from Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Professor Ma Jun from Harbin Institute of Hematology and Tumor, and Professor Zhu Jun from Peking University Cancer Hospital were invited as the chairpersons of the conference.
    Massachusetts General Hospital/Harvard Medical School/Dana-Farber Cancer Institute Jeremy Abramson, MD, Professor Song Yuqin from Peking University Cancer Hospital gave wonderful special reports
    .

    The opening speech of the conference chairman Professor Ma Jun said in his speech: Domestic CAR-T treatment has entered the clinical application stage and has become a powerful "weapon" for the treatment of relapsed/refractory large B-cell lymphoma
    .

    Professor Zhu Jun said that after the successful launch of WuXi Biotech's Ruiji Orenza injection, it has brought new choices and new hopes for Chinese patients.
    Through the continuous efforts and trials of clinicians, he hopes to accumulate more for Chinese patients.
    More treatment experience
    .

    Professor Zhixiang Shen also said that CAR-T therapy has attracted widespread attention among Chinese hematologists, and he hopes that this conference will help clinicians to understand CAR-T therapy more deeply, and it will also help the clinical practice of Ruiji Oransay injection.
    The application provides relevant experience
    .

    Special report: the origin of liso-cel and the interpretation of TRANSCEND research data.
    Subsequently, Professor Jeremy Abramson used two cases in the report to specifically explain the good effect of liso-cel in the treatment of relapsed/refractory diffuse large B-cell lymphoma
    .

    The good curative effect of liso-cel is closely related to its structure.
    The costimulatory domain of liso-cel is 4-1BB.
    Compared with CAR-T products whose costimulatory domain is CD28, it lasts longer in the body, so it has an effective duration.
    It takes longer
    .

    In addition, unlike other approved CAR-T products, the CD4 and CD8 CAR-active T cells in liso-cel are made in equal proportions at the target dose
    .

    In an in vivo modeling experiment conducted by the Fred Hutch Cancer Center, an equal proportion of CD4 and CD8 CAR active T cells effectively increased the survival rate of mice
    .

    The TRANSCEND NHL 001 study is a multi-stage, multi-center, key trial.
    The trial enrolled 269 patients.
    It is currently the only one enrolled in secondary central nervous system invasion lymphoma, transforming non-follicular Key CAR-T clinical trials for patients with indolent non-Hodgkin's lymphoma (NHL) and grade 3B follicular lymphoma, as well as patients who have previously received autologous hematopoietic stem cell transplantation
    .

    The results of the study showed that among the 256 surviving patients, the objective response rate was 73%, 53 patients achieved complete remission, the median response duration was not reached at the last follow-up, and the proportion of patients who sustained a response for 12 months was 55%.

    .

    In terms of adverse reactions, the incidence of cytokine release syndrome (CRS) of any grade is 42%, the incidence of CRS ≥3 is 2%; the incidence of neurotoxicity of any grade is 30%, and the incidence of neurotoxicity ≥3 The rate is 10%
    .

    Special report: Interpretation of long-term survival data of the RELIANCE study of Ruiji Orensai injection.
    Subsequently, Professor Song Yuqin mentioned in the report that the ideal CAR-T product should seek a balance between efficacy and safety, and the optimized CARs structure and Robust technology and rigorous quality control in the production process are the key to ensuring the efficacy and safety of CAR-T products and bringing more benefits to patients
    .

    01 Optimized CARs structure At present, most of the products that have been approved for marketing in the world are second-generation CAR-T products
    .

    4-1BB is currently the most mainstream costimulatory molecule.
    CAR-T cells based on 4-1BB continue to expand in vivo, survive longer, and have better safety
    .

    02 Robust process and rigorous quality control WuXi Genuo's robust process control is reflected in every production step to ensure the consistency and stable quality of the final product
    .

    From the original, auxiliary materials to the final product release of Ruiji Orensai injection, about 100 quality control testing procedures ensured that its production success rate reached 99%
    .

    Subsequently, Professor Song Yuqin interpreted the long-term survival data of the RELIANCE study
    .

    The RELIANCE study is currently the largest CAR-T registered clinical study in China.
    A total of 10 centers participated and more than 80 patients were reinfused
    .

    The RELIANCE study evaluated the clinical efficacy and clinical efficacy of CD19 CAR-T cells (relma-cel) in Chinese adult patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) who had previously received multi-line (≥2 lines) treatment.
    Security
    .

    03 Significant efficacy and long-term benefits for patients.
    The results of the RELIANCE study showed that the best objective response rate (ORR) at 6 months was as high as 75.
    9%, and the best complete response rate (CR) was as high as 51.
    7%
    .

    The RELIANCE study confirmed that patients with CR at 3 months can achieve long-term remission, and the 1-year overall survival (OS) rate of the intention-to-treat (ITT) population is 76.
    8%, which can provide long-term benefits
    .

    04 Good safety, low use rate of commonly used drugs to deal with adverse reactions In terms of safety, the incidence of CRS at any level is 47.
    5%, the incidence of CRS ≥3 is 5.
    1%; the incidence of neurotoxicity at any level is 20.
    3%, ≥ The incidence of grade 3 neurotoxicity was 3.
    4%
    .

    In addition, the use rate of commonly used drugs to deal with adverse reactions is relatively low.
    The use rate of tocilizumab is 28.
    8%, the use rate of glucocorticoids is 15.
    2%, and the rate of ICU admission is 1.
    7%
    .

    Prof.
    Song Yuqin then shared a case of stage IV diffuse large B-cell lymphoma (DLBCL).
    The patient has been treated with Regiorenzane injection and has been CR for nearly 3 years
    .

    Finally, Professor Song Yuqin emphasized that Ruiji Orensai injection is currently the most extensively verified and practiced CAR-T product in the Chinese R/R LBCL population, and more than 120 cases of reinfusion in the Chinese population have been successfully completed
    .

    Conference summary At the end, Professor Shen Zhixiang made a conference summary: through the interpretation of the current CAR-T key trial data by two experts, everyone has a better understanding of the efficacy and safety of Ruiji Orenza injection
    .

    Ruijio Lun Sai injection has been approved for marketing.
    How to maximize the benefits of patients in clinical use and whether CAR-T treatment should be advanced, there are still many problems that need to be solved urgently
    .

    Professor Ma Jun said: The patient's life is paramount, which is the purpose of hematological oncologists
    .

    In order to prolong the survival period of patients, in order to achieve cure for more patients, it is necessary to accumulate more clinical CAR-T treatment experience
    .

    Professor Zhu Jun said: Through the joint efforts of everyone, CAR-T therapy will definitely bring more survival benefits to Chinese patients.
    Finally, he summed up China's clinical treatment experience and contributed Chinese treatment plans
    .

    After the meeting, Professor Zhang Huilai commented on currently newly diagnosed LBCL patients using chemotherapy regimens, such as R-CHOP regimen (rituximab combined with cyclophosphamide, doxorubicin, vincristine and prednisone) after standard course of treatment, chemotherapy The median survival time of refractory patients is only about 6 months, and the effective rate of second-line or third-line treatment is only about 20%
    .

    In general, patients with R/R LBCL have a poor prognosis, and treatment needs have not been met
    .

    As an important immunotherapy, CAR-T therapy has brought great survival benefits to patients with R/R LBCL
    .

    A number of studies have confirmed that for patients with relapsed/refractory DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), including double-hit, triple-hit, and TP53 mutation patients, CAR-T treatment The effect is better than the previous treatment plan
    .

    In particular, WuXi Genuo's Regi-Olenza injection significantly prolonged the survival period of patients.
    The results of the RELIANCE study showed that the 12-month overall survival (OS) rate was as high as 76.
    8%
    .

    This is closely related to the structure of the product itself and the quality control in the production process
    .

    Therefore, after Ruiji Orensai injection is on the market, it is expected that it will bring more survival benefits to R/R LBCL patients in China! Professor Zhang Huilai Doctor of Oncology, Chief Physician, Doctoral Supervisor, Director of the Department of Lymphoma, Tianjin Medical University Cancer Hospital, Deputy Chairman of the Lymphoma Professional Committee of the Chinese Anti-Cancer Association, Member of the Standing Committee of the Chinese Society of Clinical Oncology (CSCO) Anti-Lymphoma Alliance China Healthcare Vice Chairman of the Oncology Branch of the International Exchange Promotion Association Vice Chairman of the Lymphoma Professional Committee of the Chinese Geriatric Health Association Vice Chairman of the Standing Committee of the Chinese Society of Clinical Oncology (CSCO) Oncology and Cardiology Committee Member of the Lymphoma Group of the Chinese Medical Association Oncology Branch Chinese Anti-Cancer Association Member of the Special Committee of Integrated Oncology and Cardiology, Chairman of the Lymphoma Professional Committee of Tianjin Anti-Cancer Association, Vice Chairman of Tianjin Hematology Quality Control Center, Vice Chairman of Hematologist Branch of Tianjin Medical Association Main research direction: Molecular diagnosis of malignant lymphoma And personalized treatment RECOMMEND recommended reading 1.
    Professor Jin JieDLBCL enters a new era of precision therapy, CAR-T therapy brings new hope 2.
    Professor Song Yuqin76.
    8%! RELIANCE studies the one-year OS rate to help patients benefit from long-term survival 3.
    Professor Zhu Jun | Sharing the cutting edge of innovation, accumulating Chinese experience-the first class 1 new drug CAR-T product leads the development of anti-tumor therapy stamp "Read the original text", we make progress together
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