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Chimeric antigen receptor T cell (CAR-T) therapy, as a disruptive innovative therapy, is booming in China
.
On June 22, 2021, Yikaida® (Akilunza injection) was officially approved by the National Medical Products Administration (NMPA), becoming China’s first CAR-T therapy drug targeting CD19 for the treatment of relapse/ Adult patients with refractory B-cell lymphoma (R/R LBCL) bring new treatment options to patients with R/R LBCL
.
At present, it has been approved in 38 countries around the world, and has accumulated nearly 5,000 patient experience
.
In order to promote the development of China's CAR-T field, build China's CAR-T star treatment center, and cooperate with international and domestic diagnosis and treatment
.
"CCSC (China CAR-T Star Center)-Kylinhui International Connection" continues! September 18, 2021-The new phase of Kylin Club International Connection was successfully held
.
Professor Li Jianyong of Jiangsu Provincial People’s Hospital was invited to chair this conference; Professor Lin Yi from the Department of Hematology and Experimental Pathology of Mayo Clinic Rochester District, and Professor Xu Wei from Jiangsu Provincial People’s Hospital as speakers; Wang Li from Jiangsu Provincial People’s Hospital Professor Cao Lei from Jiangsu Provincial People’s Hospital, Professor Liang Jinhua from Jiangsu Provincial People’s Hospital, Professor Wang Sanmei from Jiangsu Provincial People’s Hospital, Professor Wu Jiazhu from Jiangsu Provincial People’s Hospital, Professor Wu Wei from Jiangsu Provincial People’s Hospital, and a number of top domestic experts as panelists, focusing on CAR -A cutting-edge topic in the field of T cell therapy, in-depth discussions and exchanges on Fosun Kate's CAR-T cell therapy drug Akirensai injection
.
Below, I will take you to review the wonderful links of this conference.
I hope that this conference can expand clinicians' understanding of the clinical efficacy of Akirensai injection and further improve the clinical benefits of patients
.
From real world data to see CAR-T's actual combat experience in lymphoma Speech
.
Professor Lin Yi briefly introduced the current regulatory standards of CAR-T therapy in the United States and the FDA's risk assessment and mitigation strategy (REMS), and then demonstrated the entire management of CAR-T therapy through a real case, combined with ZUMA-1 Research and a number of real-world studies illustrate the screening strategies of patients and the effective management of adverse events when CAR-T is applied in the real world
.
Regarding the screening of patients before CAR-T treatment, Professor Lin Yi mentioned that the upper limit of the age of patients in ZUMA-1, JULIET, TRANSCEND NHL and other studies is 76 years old, while the upper limit of the age of patients in the real world can reach 83 years old
.
The results of the MDACC retrospective cohort study and the CIBMIT study showed that the efficacy and safety of CAR-T treatment in elderly patients with diffuse large B-cell lymphoma (DLBCL) ≥65 years old were not significantly different from those of patients <65 years old
.
Regarding the management of cytokine release syndrome (CRS) and neurotoxicity during CAR-T treatment, the FDA-approved REMS strategy recommends tocilizumab as the first-line treatment and steroids as the second-line treatment
.
The results of the ZUMA-1 study showed that the overall response rate (ORR), complete response rate (CR) and disease progression of patients with CRS or neurotoxicity after treatment with tocilizumab or steroids were compared with those without CRS or neurotoxicity.
There was no significant difference compared to toxic patients
.
In real-world studies, the incidence of CRS and neurotoxicity in patients is similar to that in the ZUMA-1 study, but the use of tocilizumab and steroids is higher
.
Real World Evidence for CAR-T Treatment of Lymphoma Next, Professor Xu Wei from Jiangsu Provincial People's Hospital shared a speech titled "Real World Evidence for CAR-T Treatment of Lymphoma"
.
Professor Xu Wei first introduced the current status of treatment for adult patients with DLBCL.
For patients with relapsed/refractory (r/r) DLBCL, the current treatment options are very limited, with poor efficacy and high unmet clinical needs
.
In recent years, many new treatment methods including CAR-T cell therapy have emerged, bringing new hope to patients with r/r DLBCL
.
Subsequently, Professor Xu Wei introduced the key ZUMA-1 trial in detail.
The results of the study showed that the overall survival (OS) rate of patients with r/r DLBCL after 4 years of treatment with Axicabtagene ciloleucel was 44% and was safe.
The sex is good, and no adverse events related to the new treatment of akirensai injection have been reported
.
In the real world, the survival and safety of Akirensai injection in the treatment of r/r DLBCL patients are basically equivalent to those of ZUMA-1
.
In the clinical use of CAR-T to treat patients, the cooperation between referrals and CAR-T treatment centers is very important, including patient identification, discharge and patient monitoring
.
The ZUMA-7 and ZUMA-12 studies have advanced the number of treatment lines of Akirensai injection.
The results show that compared with the combination chemotherapy regimen, the use of Akirensai injection significantly improved the patient’s event-free survival rate (EFS).
) And CR
.
The results of the ZUMA-5 study show that Akirensai injection has a good effect in the treatment of follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Compared with the SCHOLAR 5 study, it shows a clear survival advantage
.
Discussion Session: Chinese and foreign thoughts collide, exploring the clinical application of CAR-T therapy.
What are the differences between the several CAR-T products that have been marketed in clinical practice? What factors should be considered when choosing? At present, the FDA has approved a number of CAR-T products on the market.
The differences between different CAR-T products are mainly reflected in the following aspects: The costimulatory domain structure of Akirensai injection is CD28, while Tisagenlecleucel (Tisa-cel) and The costimulatory domain of Lisocabtagene maraleucel (Liso-cel) is 4-1BB.
CAR-T products with costimulatory domain of 4-1BB have a longer amplification time in the body, and the occurrence of CRS is usually delayed
.
In addition, when expanded in vitro, the CD4 and CD8 in Liso-cel are expanded in equal proportions, but there is no research showing that the ratio of CD4 and CD8 is related to the efficacy and safety of CAR-T
.
When choosing CAR-T products for clinical treatment, product efficacy is the first consideration
.
Akirensai injection has been on the market earlier, and the accumulated clinical experience is relatively rich.
The ZUMA series of studies also provide sufficient research evidence
.
In terms of safety, the occurrence of adverse events of CAR-T products currently on the market are all within a controllable range, and the management of CRS and neurotoxicity is relatively mature
.
For patients who have undergone disease progression after allogeneic hematopoietic stem cell transplantation (allo-HSCT), what factors should be considered for CAR-T treatment? At present, there are few studies on CAR-T treatment after allo-HSCT.
If the patient does not develop severe graft-versus-host disease (GvHD) after allo-HSCT treatment, CAR-T treatment can be considered
.
At the same time, it is also necessary to consider the time for the patient to receive allo-HSCT treatment, improve relevant examination data, and consider whether it is suitable for CAR-T treatment according to the patient's specific physical condition
.
Summary At the end, Professor Xu Wei made a summary of the meeting and expressed his gratitude to the experts participating in the meeting for their meticulous preparation.
He also hoped that CAR-T treatment could bring more hope to Chinese patients
.
The meeting ended successfully in the heated discussion of experts and scholars! Poke "read the original text", we make progress together
.
On June 22, 2021, Yikaida® (Akilunza injection) was officially approved by the National Medical Products Administration (NMPA), becoming China’s first CAR-T therapy drug targeting CD19 for the treatment of relapse/ Adult patients with refractory B-cell lymphoma (R/R LBCL) bring new treatment options to patients with R/R LBCL
.
At present, it has been approved in 38 countries around the world, and has accumulated nearly 5,000 patient experience
.
In order to promote the development of China's CAR-T field, build China's CAR-T star treatment center, and cooperate with international and domestic diagnosis and treatment
.
"CCSC (China CAR-T Star Center)-Kylinhui International Connection" continues! September 18, 2021-The new phase of Kylin Club International Connection was successfully held
.
Professor Li Jianyong of Jiangsu Provincial People’s Hospital was invited to chair this conference; Professor Lin Yi from the Department of Hematology and Experimental Pathology of Mayo Clinic Rochester District, and Professor Xu Wei from Jiangsu Provincial People’s Hospital as speakers; Wang Li from Jiangsu Provincial People’s Hospital Professor Cao Lei from Jiangsu Provincial People’s Hospital, Professor Liang Jinhua from Jiangsu Provincial People’s Hospital, Professor Wang Sanmei from Jiangsu Provincial People’s Hospital, Professor Wu Jiazhu from Jiangsu Provincial People’s Hospital, Professor Wu Wei from Jiangsu Provincial People’s Hospital, and a number of top domestic experts as panelists, focusing on CAR -A cutting-edge topic in the field of T cell therapy, in-depth discussions and exchanges on Fosun Kate's CAR-T cell therapy drug Akirensai injection
.
Below, I will take you to review the wonderful links of this conference.
I hope that this conference can expand clinicians' understanding of the clinical efficacy of Akirensai injection and further improve the clinical benefits of patients
.
From real world data to see CAR-T's actual combat experience in lymphoma Speech
.
Professor Lin Yi briefly introduced the current regulatory standards of CAR-T therapy in the United States and the FDA's risk assessment and mitigation strategy (REMS), and then demonstrated the entire management of CAR-T therapy through a real case, combined with ZUMA-1 Research and a number of real-world studies illustrate the screening strategies of patients and the effective management of adverse events when CAR-T is applied in the real world
.
Regarding the screening of patients before CAR-T treatment, Professor Lin Yi mentioned that the upper limit of the age of patients in ZUMA-1, JULIET, TRANSCEND NHL and other studies is 76 years old, while the upper limit of the age of patients in the real world can reach 83 years old
.
The results of the MDACC retrospective cohort study and the CIBMIT study showed that the efficacy and safety of CAR-T treatment in elderly patients with diffuse large B-cell lymphoma (DLBCL) ≥65 years old were not significantly different from those of patients <65 years old
.
Regarding the management of cytokine release syndrome (CRS) and neurotoxicity during CAR-T treatment, the FDA-approved REMS strategy recommends tocilizumab as the first-line treatment and steroids as the second-line treatment
.
The results of the ZUMA-1 study showed that the overall response rate (ORR), complete response rate (CR) and disease progression of patients with CRS or neurotoxicity after treatment with tocilizumab or steroids were compared with those without CRS or neurotoxicity.
There was no significant difference compared to toxic patients
.
In real-world studies, the incidence of CRS and neurotoxicity in patients is similar to that in the ZUMA-1 study, but the use of tocilizumab and steroids is higher
.
Real World Evidence for CAR-T Treatment of Lymphoma Next, Professor Xu Wei from Jiangsu Provincial People's Hospital shared a speech titled "Real World Evidence for CAR-T Treatment of Lymphoma"
.
Professor Xu Wei first introduced the current status of treatment for adult patients with DLBCL.
For patients with relapsed/refractory (r/r) DLBCL, the current treatment options are very limited, with poor efficacy and high unmet clinical needs
.
In recent years, many new treatment methods including CAR-T cell therapy have emerged, bringing new hope to patients with r/r DLBCL
.
Subsequently, Professor Xu Wei introduced the key ZUMA-1 trial in detail.
The results of the study showed that the overall survival (OS) rate of patients with r/r DLBCL after 4 years of treatment with Axicabtagene ciloleucel was 44% and was safe.
The sex is good, and no adverse events related to the new treatment of akirensai injection have been reported
.
In the real world, the survival and safety of Akirensai injection in the treatment of r/r DLBCL patients are basically equivalent to those of ZUMA-1
.
In the clinical use of CAR-T to treat patients, the cooperation between referrals and CAR-T treatment centers is very important, including patient identification, discharge and patient monitoring
.
The ZUMA-7 and ZUMA-12 studies have advanced the number of treatment lines of Akirensai injection.
The results show that compared with the combination chemotherapy regimen, the use of Akirensai injection significantly improved the patient’s event-free survival rate (EFS).
) And CR
.
The results of the ZUMA-5 study show that Akirensai injection has a good effect in the treatment of follicular lymphoma (FL) and marginal zone lymphoma (MZL).
Compared with the SCHOLAR 5 study, it shows a clear survival advantage
.
Discussion Session: Chinese and foreign thoughts collide, exploring the clinical application of CAR-T therapy.
What are the differences between the several CAR-T products that have been marketed in clinical practice? What factors should be considered when choosing? At present, the FDA has approved a number of CAR-T products on the market.
The differences between different CAR-T products are mainly reflected in the following aspects: The costimulatory domain structure of Akirensai injection is CD28, while Tisagenlecleucel (Tisa-cel) and The costimulatory domain of Lisocabtagene maraleucel (Liso-cel) is 4-1BB.
CAR-T products with costimulatory domain of 4-1BB have a longer amplification time in the body, and the occurrence of CRS is usually delayed
.
In addition, when expanded in vitro, the CD4 and CD8 in Liso-cel are expanded in equal proportions, but there is no research showing that the ratio of CD4 and CD8 is related to the efficacy and safety of CAR-T
.
When choosing CAR-T products for clinical treatment, product efficacy is the first consideration
.
Akirensai injection has been on the market earlier, and the accumulated clinical experience is relatively rich.
The ZUMA series of studies also provide sufficient research evidence
.
In terms of safety, the occurrence of adverse events of CAR-T products currently on the market are all within a controllable range, and the management of CRS and neurotoxicity is relatively mature
.
For patients who have undergone disease progression after allogeneic hematopoietic stem cell transplantation (allo-HSCT), what factors should be considered for CAR-T treatment? At present, there are few studies on CAR-T treatment after allo-HSCT.
If the patient does not develop severe graft-versus-host disease (GvHD) after allo-HSCT treatment, CAR-T treatment can be considered
.
At the same time, it is also necessary to consider the time for the patient to receive allo-HSCT treatment, improve relevant examination data, and consider whether it is suitable for CAR-T treatment according to the patient's specific physical condition
.
Summary At the end, Professor Xu Wei made a summary of the meeting and expressed his gratitude to the experts participating in the meeting for their meticulous preparation.
He also hoped that CAR-T treatment could bring more hope to Chinese patients
.
The meeting ended successfully in the heated discussion of experts and scholars! Poke "read the original text", we make progress together
