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In order to promote academic exchanges and scientific and technological cooperation in the field of clinical oncology in China, and actively promote the development of the discipline, the 24th session is hosted by the Chinese Society of Clinical Oncology (CSCO), Beijing Hisco Clinical Oncology Research Foundation, and the Cancer Hospital of the Chinese Academy of Medical Sciences The National Clinical Oncology Conference and the 2021 CSCO Annual Conference will be held online from September 25th to 29th, 2021
.
With the theme of "Focus on Innovative Research, Leading the Original Future", this year's National Clinical Oncology Conference brought together well-known experts at home and abroad, focused on the clinical frontiers of oncology, and presented a gluttonous academic feast
.
On this occasion, Yimaitong sincerely invites Professor Ying Zhitao from Peking University Cancer Hospital to accept an interview to share the relevant clinical experience in the screening of the chimeric antigen receptor T cell (CAR-T) treatment benefit population and the optimization of the efficacy and benefit
.
Professor Ying Zhitao, Doctor of Medicine, Peking University Cancer Hospital, Associate Chief Physician, Young Committee Member, Hematology Oncology Committee, Chinese Anti-Cancer Association, Member, Chinese Geriatric Hematology Lymphoma Group, Youth Committee, Chinese Medical Association Oncology Branch, Chinese Society of Clinical Oncology (CSCO) Youth Expert Committee Member of the Professional Committee of Clinical Research and Evaluation of Chinese Elderly Health Care Association.
Graduated from Peking University Medical School in 2009 and received a doctorate degree in oncology.
He started working in the Lymphoma Department of Peking University Cancer Hospital in 2009.
The main research direction is the standardized diagnosis and treatment of lymphoma.
Maitong: For patients with r/r DLBCL, CAR-T therapy is an important cellular immunotherapy
.
Patient screening before treatment is very important to improve the efficacy of CAR-T.
In clinical practice, what factors are mainly considered for patient selection? In the process of commercial application of CAR-T cells after the market, Professor Ying Zhitao needs to consider many factors in the selection of patients, mainly including the following aspects: age factor CAR-T treatment-related clinical research adopts the age of the enrolled patients In accordance with strict standards, the ages of patients enrolled in key clinical studies are all less than 80 years old
.
In several foreign real-world studies conducted after the commercialization of CAR-T products on the market, the upper age limit of the enrolled patients has increased.
Among them, patients over 90 years of age have received CAR-T treatment1
.
Therefore, in real-world clinical practice, CAR-T therapy may be considered for elderly patients
.
The physical status score of most key clinical studies of CAR-T treatment of patients enrolled in the Eastern Cooperative Oncology Group (ECOG) score of 0-1 points, few studies included patients with ECOG score ≥ 2 points
.
However, in the real world, some patients have poor physical status.
When these patients receive CAR-T treatment, we should consider their higher tumor burden and corresponding organ functions
.
If the patient's physical status is poor, bridging treatment may be required, otherwise, some serious toxic and side effects related to the treatment may occur after CAR-T treatment
.
Organ function status Before CAR-T treatment, it is necessary to evaluate the patient's organ function and whether it meets the criteria for receiving CAR-T treatment
.
During CAR-T treatment, some treatment-related toxic and side effects may occur.
If the patient's organ function is poor, the possibility of corresponding risks will be higher
.
Previous treatment status The current approved indications of CAR-T are used to treat patients who have received at least 2 line treatments and have failed the treatment, or have failed autologous hematopoietic stem cell transplantation
.
Therefore, before CAR-T treatment, it is necessary to evaluate the patient's previous treatment and whether it meets the criteria for receiving CAR-T treatment
.
Yimaitong: China is a big country with hepatitis B.
Many patients will be infected with or carry the hepatitis B virus.
Can hepatitis B virus carriers be treated with CAR-T? If CAR-T treatment can be accepted, what management is needed? Professor Ying Zhitao's treatment of B-cell lymphoma combined with hepatitis B is a very important issue in China
.
Several key marketing clinical study abroad CAR-T are not included in relapsed or refractory B-cell lymphoma patients with HBV
.
However, in clinical studies as well as some domestic foreign small sample of patients enrolled included patients with hepatitis B
.
The results of the study show that patients with hepatitis B are relatively safe when receiving CAR-T treatment, but the premise is to strictly monitor the level of hepatitis B virus DNA and liver function before and after treatment2,3
.
At the same time, adequate antiviral precautions should be taken to prevent the use of nucleoside (acid) analogs (NAs) to prevent the reactivation of hepatitis B virus4
.
Under the premise of strict monitoring, after the commercialized CAR-T products are on the market, it is possible to try to treat patients with relapsed and refractory B-cell lymphoma and hepatitis B, but for patients with hepatitis B virus in an activated state, the infusion needs to be delayed.
Note CAR-T
.
Yimaitong: Can patients with primary or secondary central nervous system invasion be treated with CAR-T? If so, what management needs to be done? Professor Ying Zhitao may cause neurotoxicity due to the side effects associated with CAR-T treatment.
In theory, patients with central nervous system violations are more likely to have central nervous system toxicity.
Therefore, there are fewer relevant research data, but there are also some small samples.
A large number of clinical studies are doing related explorations
.
At the 2021 International Malignant Lymphoma Conference, a retrospective clinical study in France reported on the use of CAR-T therapy for patients with primary central nervous system invasion
.
The study enrolled 9 patients.
After receiving CAR-T treatment, the complete remission (CR) rate was 56%, and the 6-month overall survival rate was >80%5
.
During the study, no serious central nervous system toxicity events occurred
.
For patients with secondary central nervous system invasion using CAR-T treatment, some small sample size clinical research data show good curative effect, and does not significantly increase the occurrence of central nervous system toxicity
.
Therefore, after the commercialized CAR-T products are on the market, some explorations can be made for patients with primary or secondary central nervous system invasion
.
Yimaitong: Can patients with other diseases such as gastrointestinal invasion, serous effusion, and autoimmune diseases be treated with CAR-T? How to manage these patients in clinical application? Professor Ying Zhitao gastrointestinal invasion In clinical studies of CAR-T treatment, gastrointestinal invasion is not an indication for the exclusion of patients in the group
.
Patients with gastrointestinal invasion need to analyze their specific conditions.
If endoscopy shows that the risk of active bleeding or perforation is very high, then after CAR-T treatment, the patient’s bleeding and perforation risk will also be Very high, so be very cautious when performing CAR-T treatment
.
If endoscopy shows that the risk of active bleeding or perforation is low, and there is no large area ulcer, such patients can consider CAR-T treatment
.
At present, some patients have been enrolled in the clinical study of CAR-T treatment.
The few patients with gastrointestinal invasion enrolled by Peking University Cancer Hospital have not experienced bleeding or perforation
.
The results of clinical studies on serous effusion show that the incidence and severity of side effects in patients with serous effusion after CAR-T treatment is higher than that of patients without serous effusion
.
Theoretically, CAR-T cells can enter the serosal cavity effusion, continuously expand and release cytokines, resulting in serious side effects
.
Therefore, patients with serous effusion should be fully evaluated before treatment, try to drain serous effusion to reduce serous effusion, thereby reducing the incidence of toxic and side effects caused by CAR-T cells
.
Autoimmune diseases In clinical studies of CAR-T therapy, patients with autoimmune diseases were not included
.
Because immunosuppressants used to treat autoimmune diseases may affect the efficacy of CAR-T cells
.
After the commercialized CAR-T products are on the market, the treatment of patients with autoimmune diseases is a problem that the clinic needs to face
.
Such patients should fully evaluate their autoimmune diseases and their combined medications before receiving treatment, and whether they will affect the subsequent expansion of CAR-T cells
.
Yimaitong: Could you please talk about the future direction of the people who are suitable for CAR-T treatment? Professor Ying Zhitao’s current CAR-T treatment is still relatively narrow.
The approved indications abroad and domestic include: relapsed/refractory diffuse large B-cell lymphoma (DLBCL), relapsed/refractory acute Lymphocytic leukemia, relapsed/refractory multiple myeloma, relapsed/refractory follicular lymphoma, relapsed/refractory mantle cell lymphoma
.
The scope of application of CAR-T treatment is mainly focused on relapsed and refractory hematological tumors.
In the future, there will be the following exploration directions: CAR-T treatment is advanced, and the effect is better.
Large B-cell lymphoma that recurs after first-line treatment is usually Will receive second-line chemotherapy combined with autologous hematopoietic stem cell transplantation
.
At present, there are many clinical studies exploring the advancement of CAR-T treatment, and patients who have relapsed after first-line treatment are included in the study
.
Among them, the TRANSFORM study of Junuo Medical has preliminarily confirmed that the efficacy of CAR-T treatment is better than that of second-line chemotherapy combined with autologous hematopoietic stem cell transplantation
.
The previous data of the ZUMA-7 study of KitePharma (a company of Gilead) in the United States also confirmed this conclusion
.
However, the recently published data from Novartis's BELINDA study failed to support this conclusion7
.
The three main clinical studies on the advancement of CAR-T treatment are still in progress, and the follow-up efficacy and long-term survival follow-up data are still to be announced
.
Expansion of indications to benefit more patients In addition to the currently approved indications, related studies are also exploring the application of CAR-T therapy in acute myeloid leukemia and T cell-derived lymphoma
.
Two domestic CAR-T products have been approved for marketing in China.
Among them, Regiorense Injection (Benoda®) is currently approved for LBCL
.
In the future, indications for relapsed and refractory follicular lymphoma and relapsed and refractory mantle cell lymphoma are also progressing very smoothly
.
The exploration of CAR-T therapy in solid tumors.
The application of CAR-T therapy in solid tumors has been advancing.
The current research data shows that the efficacy of CAR-T in the treatment of solid tumors is still far behind the treatment of hematological tumors
.
However, in the future, with technological breakthroughs and the increase in clinical trial data, CAR-T treatment will bring clinical benefits to more solid tumor patients
.
com/news/media-releases/novartis-provides-update-belinda-study-investigating-kymriah-second-line-treatment-aggressive-b-cell-non-hodgkin-lymphoma.
RECOMMEND recommended reading 1.
Professor Jin JieDLBCL Entering 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 innovation frontiers and accumulating Chinese experience-the first class 1 new drug CAR-T product leads the development of anti-tumor therapy 4.
2021 CSCO | WuXi Juno Satellite Meeting : Based on China, forging ahead, Benoda ® helps patients with long-term survival benefit.
"Read the original text" and we will make progress together
.
With the theme of "Focus on Innovative Research, Leading the Original Future", this year's National Clinical Oncology Conference brought together well-known experts at home and abroad, focused on the clinical frontiers of oncology, and presented a gluttonous academic feast
.
On this occasion, Yimaitong sincerely invites Professor Ying Zhitao from Peking University Cancer Hospital to accept an interview to share the relevant clinical experience in the screening of the chimeric antigen receptor T cell (CAR-T) treatment benefit population and the optimization of the efficacy and benefit
.
Professor Ying Zhitao, Doctor of Medicine, Peking University Cancer Hospital, Associate Chief Physician, Young Committee Member, Hematology Oncology Committee, Chinese Anti-Cancer Association, Member, Chinese Geriatric Hematology Lymphoma Group, Youth Committee, Chinese Medical Association Oncology Branch, Chinese Society of Clinical Oncology (CSCO) Youth Expert Committee Member of the Professional Committee of Clinical Research and Evaluation of Chinese Elderly Health Care Association.
Graduated from Peking University Medical School in 2009 and received a doctorate degree in oncology.
He started working in the Lymphoma Department of Peking University Cancer Hospital in 2009.
The main research direction is the standardized diagnosis and treatment of lymphoma.
Maitong: For patients with r/r DLBCL, CAR-T therapy is an important cellular immunotherapy
.
Patient screening before treatment is very important to improve the efficacy of CAR-T.
In clinical practice, what factors are mainly considered for patient selection? In the process of commercial application of CAR-T cells after the market, Professor Ying Zhitao needs to consider many factors in the selection of patients, mainly including the following aspects: age factor CAR-T treatment-related clinical research adopts the age of the enrolled patients In accordance with strict standards, the ages of patients enrolled in key clinical studies are all less than 80 years old
.
In several foreign real-world studies conducted after the commercialization of CAR-T products on the market, the upper age limit of the enrolled patients has increased.
Among them, patients over 90 years of age have received CAR-T treatment1
.
Therefore, in real-world clinical practice, CAR-T therapy may be considered for elderly patients
.
The physical status score of most key clinical studies of CAR-T treatment of patients enrolled in the Eastern Cooperative Oncology Group (ECOG) score of 0-1 points, few studies included patients with ECOG score ≥ 2 points
.
However, in the real world, some patients have poor physical status.
When these patients receive CAR-T treatment, we should consider their higher tumor burden and corresponding organ functions
.
If the patient's physical status is poor, bridging treatment may be required, otherwise, some serious toxic and side effects related to the treatment may occur after CAR-T treatment
.
Organ function status Before CAR-T treatment, it is necessary to evaluate the patient's organ function and whether it meets the criteria for receiving CAR-T treatment
.
During CAR-T treatment, some treatment-related toxic and side effects may occur.
If the patient's organ function is poor, the possibility of corresponding risks will be higher
.
Previous treatment status The current approved indications of CAR-T are used to treat patients who have received at least 2 line treatments and have failed the treatment, or have failed autologous hematopoietic stem cell transplantation
.
Therefore, before CAR-T treatment, it is necessary to evaluate the patient's previous treatment and whether it meets the criteria for receiving CAR-T treatment
.
Yimaitong: China is a big country with hepatitis B.
Many patients will be infected with or carry the hepatitis B virus.
Can hepatitis B virus carriers be treated with CAR-T? If CAR-T treatment can be accepted, what management is needed? Professor Ying Zhitao's treatment of B-cell lymphoma combined with hepatitis B is a very important issue in China
.
Several key marketing clinical study abroad CAR-T are not included in relapsed or refractory B-cell lymphoma patients with HBV
.
However, in clinical studies as well as some domestic foreign small sample of patients enrolled included patients with hepatitis B
.
The results of the study show that patients with hepatitis B are relatively safe when receiving CAR-T treatment, but the premise is to strictly monitor the level of hepatitis B virus DNA and liver function before and after treatment2,3
.
At the same time, adequate antiviral precautions should be taken to prevent the use of nucleoside (acid) analogs (NAs) to prevent the reactivation of hepatitis B virus4
.
Under the premise of strict monitoring, after the commercialized CAR-T products are on the market, it is possible to try to treat patients with relapsed and refractory B-cell lymphoma and hepatitis B, but for patients with hepatitis B virus in an activated state, the infusion needs to be delayed.
Note CAR-T
.
Yimaitong: Can patients with primary or secondary central nervous system invasion be treated with CAR-T? If so, what management needs to be done? Professor Ying Zhitao may cause neurotoxicity due to the side effects associated with CAR-T treatment.
In theory, patients with central nervous system violations are more likely to have central nervous system toxicity.
Therefore, there are fewer relevant research data, but there are also some small samples.
A large number of clinical studies are doing related explorations
.
At the 2021 International Malignant Lymphoma Conference, a retrospective clinical study in France reported on the use of CAR-T therapy for patients with primary central nervous system invasion
.
The study enrolled 9 patients.
After receiving CAR-T treatment, the complete remission (CR) rate was 56%, and the 6-month overall survival rate was >80%5
.
During the study, no serious central nervous system toxicity events occurred
.
For patients with secondary central nervous system invasion using CAR-T treatment, some small sample size clinical research data show good curative effect, and does not significantly increase the occurrence of central nervous system toxicity
.
Therefore, after the commercialized CAR-T products are on the market, some explorations can be made for patients with primary or secondary central nervous system invasion
.
Yimaitong: Can patients with other diseases such as gastrointestinal invasion, serous effusion, and autoimmune diseases be treated with CAR-T? How to manage these patients in clinical application? Professor Ying Zhitao gastrointestinal invasion In clinical studies of CAR-T treatment, gastrointestinal invasion is not an indication for the exclusion of patients in the group
.
Patients with gastrointestinal invasion need to analyze their specific conditions.
If endoscopy shows that the risk of active bleeding or perforation is very high, then after CAR-T treatment, the patient’s bleeding and perforation risk will also be Very high, so be very cautious when performing CAR-T treatment
.
If endoscopy shows that the risk of active bleeding or perforation is low, and there is no large area ulcer, such patients can consider CAR-T treatment
.
At present, some patients have been enrolled in the clinical study of CAR-T treatment.
The few patients with gastrointestinal invasion enrolled by Peking University Cancer Hospital have not experienced bleeding or perforation
.
The results of clinical studies on serous effusion show that the incidence and severity of side effects in patients with serous effusion after CAR-T treatment is higher than that of patients without serous effusion
.
Theoretically, CAR-T cells can enter the serosal cavity effusion, continuously expand and release cytokines, resulting in serious side effects
.
Therefore, patients with serous effusion should be fully evaluated before treatment, try to drain serous effusion to reduce serous effusion, thereby reducing the incidence of toxic and side effects caused by CAR-T cells
.
Autoimmune diseases In clinical studies of CAR-T therapy, patients with autoimmune diseases were not included
.
Because immunosuppressants used to treat autoimmune diseases may affect the efficacy of CAR-T cells
.
After the commercialized CAR-T products are on the market, the treatment of patients with autoimmune diseases is a problem that the clinic needs to face
.
Such patients should fully evaluate their autoimmune diseases and their combined medications before receiving treatment, and whether they will affect the subsequent expansion of CAR-T cells
.
Yimaitong: Could you please talk about the future direction of the people who are suitable for CAR-T treatment? Professor Ying Zhitao’s current CAR-T treatment is still relatively narrow.
The approved indications abroad and domestic include: relapsed/refractory diffuse large B-cell lymphoma (DLBCL), relapsed/refractory acute Lymphocytic leukemia, relapsed/refractory multiple myeloma, relapsed/refractory follicular lymphoma, relapsed/refractory mantle cell lymphoma
.
The scope of application of CAR-T treatment is mainly focused on relapsed and refractory hematological tumors.
In the future, there will be the following exploration directions: CAR-T treatment is advanced, and the effect is better.
Large B-cell lymphoma that recurs after first-line treatment is usually Will receive second-line chemotherapy combined with autologous hematopoietic stem cell transplantation
.
At present, there are many clinical studies exploring the advancement of CAR-T treatment, and patients who have relapsed after first-line treatment are included in the study
.
Among them, the TRANSFORM study of Junuo Medical has preliminarily confirmed that the efficacy of CAR-T treatment is better than that of second-line chemotherapy combined with autologous hematopoietic stem cell transplantation
.
The previous data of the ZUMA-7 study of KitePharma (a company of Gilead) in the United States also confirmed this conclusion
.
However, the recently published data from Novartis's BELINDA study failed to support this conclusion7
.
The three main clinical studies on the advancement of CAR-T treatment are still in progress, and the follow-up efficacy and long-term survival follow-up data are still to be announced
.
Expansion of indications to benefit more patients In addition to the currently approved indications, related studies are also exploring the application of CAR-T therapy in acute myeloid leukemia and T cell-derived lymphoma
.
Two domestic CAR-T products have been approved for marketing in China.
Among them, Regiorense Injection (Benoda®) is currently approved for LBCL
.
In the future, indications for relapsed and refractory follicular lymphoma and relapsed and refractory mantle cell lymphoma are also progressing very smoothly
.
The exploration of CAR-T therapy in solid tumors.
The application of CAR-T therapy in solid tumors has been advancing.
The current research data shows that the efficacy of CAR-T in the treatment of solid tumors is still far behind the treatment of hematological tumors
.
However, in the future, with technological breakthroughs and the increase in clinical trial data, CAR-T treatment will bring clinical benefits to more solid tumor patients
.
com/news/media-releases/novartis-provides-update-belinda-study-investigating-kymriah-second-line-treatment-aggressive-b-cell-non-hodgkin-lymphoma.
RECOMMEND recommended reading 1.
Professor Jin JieDLBCL Entering 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 innovation frontiers and accumulating Chinese experience-the first class 1 new drug CAR-T product leads the development of anti-tumor therapy 4.
2021 CSCO | WuXi Juno Satellite Meeting : Based on China, forging ahead, Benoda ® helps patients with long-term survival benefit.
"Read the original text" and we will make progress together
