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Primary patients with large B-cell lymphoma (LBCL) who are refractory to first-line treatment or who relapse ≤ 12 months after treatment have poor outcomes after standard treatment (SOC), salvage chemotherapy (CT), and autologous stem cell transplantation (ASCT).
The overall survival (OS) is short, and therapeutic drugs with new mechanisms of action are urgently needed to improve survival
.
In recent years, with the gradual rise of CAR-T cell technology, CAR-T cell therapy is gradually becoming the cornerstone therapy for hematological tumors
.
The 2021 American Society of Hematology (ASH) annual meeting announced a number of CAR-T treatments for relapsed or refractory (R/R) LBCL research progress.
Yimaitong specially invited Professor Huang Huiqiang from Sun Yat-sen University Cancer Hospital Research for interpretation
.
Yimaitong: Based on the 2021 ASH conference TRANSFORM research data, please interpret the research data of liso-cel in the treatment of relapsed or refractory (R/R) large B-cell lymphoma (LBCL) and the comparison of liso-cel with standard treatment The advantages? Professor Huang Huiqiang has a poor prognosis for patients with R/R LBCL.
The first-line treatment is to give ASCT after salvaging the chemotherapy regimen
.
Among refractory patients who progressed during the initial immunochemotherapy or within 1 year after the first remission, only 30%-40% of patients respond to salvage chemotherapy and may receive ASCT consolidation therapy later, and about 50% of these patients It will relapse after transplantation, and the prognosis is poor
.
At present, two high-level CAR-T products have been marketed in China.
A number of studies have shown that CAR-T cells have achieved greater success in the treatment of R/R LBCL
.
In the global, multicenter Phase 3 TRANSFORM trial, researchers compared the efficacy and safety of liso-cel with the current standard treatment regimen in R/R LBCL patients
.
A total of 184 patients were included in the study, and they were randomly divided into standard regimen treatment and liso-cel treatment
.
Compared with the standard treatment group, the EFS (10.
1 vs 2.
3 months), complete remission (CR) rate (66% vs 39%) and PFS (median PFS 14.
8 vs 5.
7 months) of the liso-cel group showed clinical significance Improvement
.
Although the OS data was not mature at the time of this analysis, the median follow-up time was 6.
2 months, but the numerical trend was in favor of the liso-cel group, and the liso-cel showed good safety characteristics, and no new ones were found in the second-line treatment.
Safety signal, expect longer follow-up time clinical data
.
Yimaitong: The TRANSFORM study shows that compared with standard treatment, liso-cel has significantly improved EFS, CR rate and PFS, and shows good safety characteristics.
What kind of clinical data does this data have for doctors and patients? Meaning and value? What do you think the status of CAR-T treatment will develop in the future, and will it change the treatment model? Professor Huang Huiqiang, both doctors and patients, are looking forward to drugs that can provide patients with a high remission rate, CR rate, and the remission time can be maintained
.
TRANSFORM research data show that liso-cel significantly improves the EFS, CR rate, and PFS of R/R LBCL patients, and has good safety
.
This study provides support for liso-cel as a potential new standard program for second-line treatment of R/R LBCL patients, and also increases the confidence of R/R LBCL patients and doctors
.
In recent years, CAR-T therapy has indeed provided a brand new treatment plan for the R/R LBCL group, and it is also changing the treatment pattern and treatment concept of R/R LBCL.
.
Although a small number of patients may have recurrence, new treatment experience suggests that if CAR-T treatment is moved forward, or combined with other targeted drugs or treatment methods, the patient's remission rate will be further improved, and the remission time will be further Prolonged, it is hoped that the combined treatment program containing CAR-T can improve the survival outcome of R/R LBCL patients in the future
.
Yimaitong: Based on the 2021 ASH conference OUTREACH study, would you please interpret the design of the study and the difference in efficacy and safety of liso-cel in the treatment of R/R LBCL patients in outpatients and inpatients? Professor Huang Huiqiang is concerned about the management of adverse events (AE), CAR-T therapy is mostly used in inpatient treatment, and has not specifically studied the infusion and monitoring of patients receiving CAR-T cell therapy in non-university medical centers (NMCs) and outpatient settings.
.
The OUTREACH study is the only clinical trial that evaluates CAR-T cell therapy in the NMCs outpatient setting.
It aims to observe the effectiveness and safety of liso-cel in the treatment of inpatient and outpatient R/R LBCL patients in NMC, which is of extraordinary significance
.
Outpatient treatment has strict safety requirements for liso-cel, which requires patient education, establishment of sites close to treatment, and each site has a multidisciplinary CAR-T cell therapy team and standard operating procedures (SOP) for toxicity monitoring And CRS/NE managed admission
.
The study included 71 patients who received liso-cel treatment at NMC (inpatients, n=19; outpatients, n=52), with a median age of 65 years.
The efficacy of all patients can be assessed, and the objective response rate is ORR It is 77% and the CR rate is 51%
.
Studies have shown that liso-cel has long-lasting clinical activity and good safety in both outpatient and hospitalized patients.
The incidence of severe CRS and NE is low, and the incidence of any grade of CRS and NE is in outpatients and inpatients.
Similar to patients, this study provides a supporting basis for patients to administer liso-cel in an outpatient setting
.
However, the current domestic CAR-T treatment is still in its infancy, and the hospital manpower arrangement may not be able to meet the configuration of the OUTREACH study.
Therefore, if domestic patients need CAR-T treatment, it is still recommended to be hospitalized for real-time monitoring
.
Yimaitong: CAR-T cell therapy has gradually become one of the main treatments for hematological tumors.
Benoda® (Rigiolense Injection), which has been approved in China, is a subsidiary of WuXi Junuo in Junuo Medical (a company Based on the CAR-T cell process platform of Bristol-Myers Squibb, a self-developed CD19-targeting autologous CAR-T cell immunotherapy product, what are the similarities and differences? Professor Huang Huiqiang’s liso-cel is a CAR-T cell therapy targeting CD19 antigen.
Its unique feature is that the structure of CAR-T uses a costimulatory domain of 4-1BB, and the ratio of CD8-positive and CD4-positive T cells is obtained.
Control (1:1), which can better control the side effects of cell therapy
.
Benoda ® (Rigid Orlens Injection) is a self-developed CD19-targeting autologous CAR-T cell immunotherapy product based on the CAR-T cell process platform of Junuo Medical.
4-1BB is the costimulatory domain.
Compared with CD28 costimulatory domain, CAR-T cells survive in the body for a longer time
.
In addition, Ruiqiolense injection has been clinically tested in China.
The study shows that the OS rate of R/R LBCL patients reaches 76.
8% one year after treatment, and it has the same excellent safety as liso-cel
.
Summary R/R LBCL patients have a poor prognosis, a lower response to traditional chemotherapy, and a shorter OS
.
With the gradual rise of CAR-T cell technology, CAR-T cell therapy is gradually becoming the cornerstone therapy for hematological tumors
.
The TRANSFORM study and the OUTREACH study confirmed the long-term survival benefit and good safety of liso-cel.
The TRANSFORM study showed that compared with the standard treatment group, the EFS (10.
1 vs 2.
3 months) and CR rate (66 % vs 39%) and PFS (median PFS 14.
8 vs 5.
7 months) significantly improved.
The OUTREACH study showed that liso-cel has similar efficacy and safety in inpatients and outpatients
.
In addition, the domestic approved Ruiji Orenxil injection has the same excellent safety as liso-cel.
A clinical trial RELIANCE study from China was also reported at this year's ASH conference.
The research data shows that R/R In LBCL patients, the one-year OS rate is as high as 76.
8% under the treatment of Ruiji Orenza injection
.
All in all, this year's ASH conference was brilliant, and the clinical data of CAR-T cell therapy presented in various studies brought hope to R/R LBCL patients
.
Professor Huang Huiqiang, Chief Physician, Professor, and Doctoral Supervisor, Deputy Director of the Department of Internal Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University Cancer Hospital Chief Expert of Lymphoma, Chairman of the Lymphoma Professional Committee of the Chinese Geriatric Healthcare Association, CSCO Vice Chairman of the China Anti-Lymph Alliance CSCO Thyroid Cancer Committee Chairman, Chinese Anti-Cancer Association Lymphoma Professional Committee, Vice Chairman, Chinese Anti-Cancer Association Lymphoma Professional Committee, Youth Committee, Chairman, Guangdong Anti-Cancer Association, Hematology and Oncology Professional Committee Honorary Chairman, Guangdong Provincial Society of Integrated Traditional Chinese and Western Medicine, Hematology Professional Committee, Vice Chairman Poke "read the original text", we make progress together
The overall survival (OS) is short, and therapeutic drugs with new mechanisms of action are urgently needed to improve survival
.
In recent years, with the gradual rise of CAR-T cell technology, CAR-T cell therapy is gradually becoming the cornerstone therapy for hematological tumors
.
The 2021 American Society of Hematology (ASH) annual meeting announced a number of CAR-T treatments for relapsed or refractory (R/R) LBCL research progress.
Yimaitong specially invited Professor Huang Huiqiang from Sun Yat-sen University Cancer Hospital Research for interpretation
.
Yimaitong: Based on the 2021 ASH conference TRANSFORM research data, please interpret the research data of liso-cel in the treatment of relapsed or refractory (R/R) large B-cell lymphoma (LBCL) and the comparison of liso-cel with standard treatment The advantages? Professor Huang Huiqiang has a poor prognosis for patients with R/R LBCL.
The first-line treatment is to give ASCT after salvaging the chemotherapy regimen
.
Among refractory patients who progressed during the initial immunochemotherapy or within 1 year after the first remission, only 30%-40% of patients respond to salvage chemotherapy and may receive ASCT consolidation therapy later, and about 50% of these patients It will relapse after transplantation, and the prognosis is poor
.
At present, two high-level CAR-T products have been marketed in China.
A number of studies have shown that CAR-T cells have achieved greater success in the treatment of R/R LBCL
.
In the global, multicenter Phase 3 TRANSFORM trial, researchers compared the efficacy and safety of liso-cel with the current standard treatment regimen in R/R LBCL patients
.
A total of 184 patients were included in the study, and they were randomly divided into standard regimen treatment and liso-cel treatment
.
Compared with the standard treatment group, the EFS (10.
1 vs 2.
3 months), complete remission (CR) rate (66% vs 39%) and PFS (median PFS 14.
8 vs 5.
7 months) of the liso-cel group showed clinical significance Improvement
.
Although the OS data was not mature at the time of this analysis, the median follow-up time was 6.
2 months, but the numerical trend was in favor of the liso-cel group, and the liso-cel showed good safety characteristics, and no new ones were found in the second-line treatment.
Safety signal, expect longer follow-up time clinical data
.
Yimaitong: The TRANSFORM study shows that compared with standard treatment, liso-cel has significantly improved EFS, CR rate and PFS, and shows good safety characteristics.
What kind of clinical data does this data have for doctors and patients? Meaning and value? What do you think the status of CAR-T treatment will develop in the future, and will it change the treatment model? Professor Huang Huiqiang, both doctors and patients, are looking forward to drugs that can provide patients with a high remission rate, CR rate, and the remission time can be maintained
.
TRANSFORM research data show that liso-cel significantly improves the EFS, CR rate, and PFS of R/R LBCL patients, and has good safety
.
This study provides support for liso-cel as a potential new standard program for second-line treatment of R/R LBCL patients, and also increases the confidence of R/R LBCL patients and doctors
.
In recent years, CAR-T therapy has indeed provided a brand new treatment plan for the R/R LBCL group, and it is also changing the treatment pattern and treatment concept of R/R LBCL.
.
Although a small number of patients may have recurrence, new treatment experience suggests that if CAR-T treatment is moved forward, or combined with other targeted drugs or treatment methods, the patient's remission rate will be further improved, and the remission time will be further Prolonged, it is hoped that the combined treatment program containing CAR-T can improve the survival outcome of R/R LBCL patients in the future
.
Yimaitong: Based on the 2021 ASH conference OUTREACH study, would you please interpret the design of the study and the difference in efficacy and safety of liso-cel in the treatment of R/R LBCL patients in outpatients and inpatients? Professor Huang Huiqiang is concerned about the management of adverse events (AE), CAR-T therapy is mostly used in inpatient treatment, and has not specifically studied the infusion and monitoring of patients receiving CAR-T cell therapy in non-university medical centers (NMCs) and outpatient settings.
.
The OUTREACH study is the only clinical trial that evaluates CAR-T cell therapy in the NMCs outpatient setting.
It aims to observe the effectiveness and safety of liso-cel in the treatment of inpatient and outpatient R/R LBCL patients in NMC, which is of extraordinary significance
.
Outpatient treatment has strict safety requirements for liso-cel, which requires patient education, establishment of sites close to treatment, and each site has a multidisciplinary CAR-T cell therapy team and standard operating procedures (SOP) for toxicity monitoring And CRS/NE managed admission
.
The study included 71 patients who received liso-cel treatment at NMC (inpatients, n=19; outpatients, n=52), with a median age of 65 years.
The efficacy of all patients can be assessed, and the objective response rate is ORR It is 77% and the CR rate is 51%
.
Studies have shown that liso-cel has long-lasting clinical activity and good safety in both outpatient and hospitalized patients.
The incidence of severe CRS and NE is low, and the incidence of any grade of CRS and NE is in outpatients and inpatients.
Similar to patients, this study provides a supporting basis for patients to administer liso-cel in an outpatient setting
.
However, the current domestic CAR-T treatment is still in its infancy, and the hospital manpower arrangement may not be able to meet the configuration of the OUTREACH study.
Therefore, if domestic patients need CAR-T treatment, it is still recommended to be hospitalized for real-time monitoring
.
Yimaitong: CAR-T cell therapy has gradually become one of the main treatments for hematological tumors.
Benoda® (Rigiolense Injection), which has been approved in China, is a subsidiary of WuXi Junuo in Junuo Medical (a company Based on the CAR-T cell process platform of Bristol-Myers Squibb, a self-developed CD19-targeting autologous CAR-T cell immunotherapy product, what are the similarities and differences? Professor Huang Huiqiang’s liso-cel is a CAR-T cell therapy targeting CD19 antigen.
Its unique feature is that the structure of CAR-T uses a costimulatory domain of 4-1BB, and the ratio of CD8-positive and CD4-positive T cells is obtained.
Control (1:1), which can better control the side effects of cell therapy
.
Benoda ® (Rigid Orlens Injection) is a self-developed CD19-targeting autologous CAR-T cell immunotherapy product based on the CAR-T cell process platform of Junuo Medical.
4-1BB is the costimulatory domain.
Compared with CD28 costimulatory domain, CAR-T cells survive in the body for a longer time
.
In addition, Ruiqiolense injection has been clinically tested in China.
The study shows that the OS rate of R/R LBCL patients reaches 76.
8% one year after treatment, and it has the same excellent safety as liso-cel
.
Summary R/R LBCL patients have a poor prognosis, a lower response to traditional chemotherapy, and a shorter OS
.
With the gradual rise of CAR-T cell technology, CAR-T cell therapy is gradually becoming the cornerstone therapy for hematological tumors
.
The TRANSFORM study and the OUTREACH study confirmed the long-term survival benefit and good safety of liso-cel.
The TRANSFORM study showed that compared with the standard treatment group, the EFS (10.
1 vs 2.
3 months) and CR rate (66 % vs 39%) and PFS (median PFS 14.
8 vs 5.
7 months) significantly improved.
The OUTREACH study showed that liso-cel has similar efficacy and safety in inpatients and outpatients
.
In addition, the domestic approved Ruiji Orenxil injection has the same excellent safety as liso-cel.
A clinical trial RELIANCE study from China was also reported at this year's ASH conference.
The research data shows that R/R In LBCL patients, the one-year OS rate is as high as 76.
8% under the treatment of Ruiji Orenza injection
.
All in all, this year's ASH conference was brilliant, and the clinical data of CAR-T cell therapy presented in various studies brought hope to R/R LBCL patients
.
Professor Huang Huiqiang, Chief Physician, Professor, and Doctoral Supervisor, Deputy Director of the Department of Internal Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University Cancer Hospital Chief Expert of Lymphoma, Chairman of the Lymphoma Professional Committee of the Chinese Geriatric Healthcare Association, CSCO Vice Chairman of the China Anti-Lymph Alliance CSCO Thyroid Cancer Committee Chairman, Chinese Anti-Cancer Association Lymphoma Professional Committee, Vice Chairman, Chinese Anti-Cancer Association Lymphoma Professional Committee, Youth Committee, Chairman, Guangdong Anti-Cancer Association, Hematology and Oncology Professional Committee Honorary Chairman, Guangdong Provincial Society of Integrated Traditional Chinese and Western Medicine, Hematology Professional Committee, Vice Chairman Poke "read the original text", we make progress together
