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Indolent B-cell lymphoma is a relatively common type of lymphoma.
Although the development rate is slower and the patient's survival period is longer, the patient usually cannot be completely cured
.
In recent years, the treatment of indolent B-cell lymphoma has gradually shifted from the optimization of treatment plans to the optimization of therapeutic drugs
.
New drugs led by a new generation of anti-CD20 monoclonal antibody otuzumab have shown better efficacy and safety in the treatment of indolent B-cell lymphoma, bringing more benefits to patients
.
In this regard, Yimaitong was fortunate to connect with Professor Wang Xin of Shandong Provincial Hospital to give a detailed explanation on the treatment progress of new drugs led by otuzumab in indolent B-cell lymphoma
.
Q1: First of all, could you please briefly introduce the current status of treatment of indolent B-cell lymphoma at home and abroad? Professor Wang Xin indolent B-cell lymphoma is a relatively common type of lymphoma, which develops slowly and is less aggressive
.
Patients with indolent B-cell lymphoma survive longer, and most patients survive for more than 10 years
.
But indolent B-cell lymphoma usually cannot be completely cured, and patients will experience repeated disease relapses
.
At present, some patients with relapsed indolent B-cell lymphoma, including follicular lymphoma (FL) patients with early disease progression, and patients with relapsed and refractory marginal zone lymphoma (MZL) still lack effective treatment options
.
In recent years, the treatment of indolent B-cell lymphoma has gradually shifted from the optimization of treatment plans to the optimization of therapeutic drugs
.
New drugs represented by the new generation of anti-CD20 monoclonal antibody otuzumab have demonstrated excellent efficacy and safety in indolent B-cell lymphoma
.
The emergence of many new drugs is expected to bring new changes to the treatment of indolent B-cell lymphoma
.
Q2: Could you please introduce the application status of otuzumab in indolent B-cell lymphoma? Professor Wang Xin Otuzumab is the world's first type II glycosylated humanized CD20 monoclonal antibody.
In the treatment of CD20-positive B-cell lymphoma, otuzumab is a new drug across the age
.
According to the currently reported data, otuzumab has achieved significant benefits in the treatment of indolent lymphoma
.
The GALLIUM study is a global multicenter, randomized controlled phase III clinical study that compared the efficacy of otuzumab (G) combined with chemotherapy and rituximab (R) combined with chemotherapy for induction treatment of newly treated FL patients
.
Compared with R-chemotherapy, G-chemotherapy reduces the risk of disease progression, recurrence and death by 34%, prolongs the time to next treatment (TTNT) by 28%, and reduces the risk of disease progression (POD24) by 46% within 24 months
.
The GADOLIN study is a global, multi-center, randomized controlled phase III clinical study.
FL patients with relapsed and refractory rituximab were enrolled to receive bendamustine monotherapy and otuzumab combined with benda.
Mustine (GB regimen) treatment
.
The results of the study show that compared with bendamustine single agent, the GB regimen has a significant effect
.
At a median follow-up of 31.
8 months, the risk of disease progression in the GB regimen was reduced by 43%, the median progression-free survival (PFS) was extended to 25.
8 months, and overall survival (OS) was significantly prolonged (P=0.
0269)
.
Whether it is initial treatment of FL or relapsed and refractory FL, the otuzumab combination program has shown excellent efficacy and provides a better treatment plan for FL patients
.
In addition to FL, otuzumab has also carried out related studies to observe the efficacy and safety of other indolent B-cell lymphomas
.
The CLL14 study showed that compared with the combination of otuzumab and chlorambucil, the combination of otuzumab and the Bcl-2 inhibitor venecla regimen can bring significant benefits to patients with chronic lymphocytic leukemia (CLL)
.
At a median follow-up of 39.
6 months, the 3-year PFS rate (81.
9% vs 49.
5%) of the combination of otuzumab and venecla regimen was higher, and the negative rate of peripheral blood minimal residual disease (MRD) 3 months after the end of treatment ( 75.
5% vs 35.
2%) and the MRD negative rate in the bone marrow (56.
9% vs 17.
1%) is also higher
.
In addition, compared with the regimen of otuzumab combined with chlorambucil, otuzumab combined with BTK inhibitor ibrutinib can be used in CLL or small lymphocyte lymph nodes with high risk factors (IGHV not mutated or TP53 abnormal).
Patients with tumor (SLL) also brought significant PFS benefits, with PFS rates at 30 months of 79% and 31%, respectively
.
Related real-world studies have also verified the efficacy of otuzumab
.
The GO-CLLEAR study included 63 CLL patients from 10 centers who were treated with otuzumab combined with chlorambucil regimen
.
The results of the study showed that the total response rate (ORR) of otuzumab combined with chlorambucil reached 76%, the complete response (CR) rate reached 30%, and the median event-free survival (EFS) was 49.
0 months.
.
The efficacy of the combination regimen of otuzumab in CLL patients in real-world studies is consistent with prospective clinical studies, which can bring better prognosis for CLL patients
.
Although CLL/SLL patients can obtain a better prognosis and longer survival through treatment with small molecule drugs such as BTK inhibitors, drug resistance is still a difficult problem in the treatment of CLL/SLL patients
.
In related studies, the associated combination of otuzumab has shown excellent efficacy and safety in CLL/SLL patients, and will provide more treatment options for CLL/SLL patients, and further improve the prognosis and quality of life of CLL/SLL patients
.
Q3: Otuzumab is also used in the treatment of other indolent B-cell lymphomas.
Can you introduce it? Professor Wang Xin Otuzumab has become one of the hotspots in the treatment of other indolent B-cell lymphomas.
Its mode of action includes induction of antibody-dependent cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and direct cell death (DCD)
.
Otuzumab combined with Ibrutinib and Venecla showed synergistic effects in preclinical models of mantle cell lymphoma
.
The phase I/II OAIs (NCT02558816) study aims to determine the maximum tolerated dose of venecola combined with fixed-dose ibrutinib and otuzumab in patients with relapsed mantle cell lymphoma (MCL), and at the same time for relapse and initial Open the extended cohort to treat patients to determine the safety and effectiveness of the program
.
The study enrolled 48 patients with MCL from October 14, 2015 to May 29, 2018
.
At the end of the sixth cycle of treatment, PET-CT assessed the CR rate of 86.
6% of patients with newly treated MCL, and the CR rate of patients with relapsed MCL was 67%
.
At a median follow-up of 17 months, the 2-year PFS rate of the combined regimen in patients with relapsed MCL was 69.
5%, and the 2-year OS rate was 68.
6%
.
At a median follow-up of 14 months, the 1-year PFS rate of the combined regimen in newly treated MCL patients was 93.
3%
.
The otuzumab combination regimen has shown considerable efficacy and good safety in patients with relapsed and refractory MCL.
For patients with relapsed and refractory MCL, especially rituximab-resistant relapsed and refractory MCL patients, Austria The combination of touzumab is expected to provide new treatment options
.
At various academic conferences in recent years, the combination of otuzumab and other drugs has shown excellent efficacy in the field of indolent lymphoma.
We look forward to the exploration of more therapeutic combinations in the future and the publication of larger sample research data
.
Q4: What do you think is the prospect of otuzumab in the treatment of other indolent lymphomas? Professor Wang Xin still has many unmet needs in patients receiving anti-CD20 therapy
.
Many patients will face problems such as repeated disease relapses, shortened duration of remission, and reduced quality of treatment
.
With the development of new anti-CD20 monoclonal antibodies, the understanding of the mechanisms of relapse and resistance continues to deepen, and new anti-CD20 monoclonal antibodies will bring more benefits to patients with indolent lymphoma
.
As a new type of humanized CD20 antibody, otuzumab may achieve better efficacy in more combination programs
.
Preclinical models of otuzumab combined with ibrutinib and veneclax in the preclinical model of MCL and preliminary data in the treatment of newly-treated MCL have shown good efficacy and safety; in CLL patients (CLL11) and rituximab Prolongation of OS has been observed in patients with refractory FL (GADOLIN)
.
Currently, otuzumab is combined with a variety of drugs, including BTK inhibitors, Bcl-2 inhibitors, immunomodulators and other related clinical studies are underway
.
Otuzumab has been on the market for more than two months in China, and many patients with indolent lymphoma in our department have also benefited from the use of otuzumab.
I believe that with the application of otuzumab in China, it will further improve The survival of lymphoma patients brings new hope to lymphoma patients
.
Professor Wang Xin Shandong Provincial Hospital, Director of the Department of Hematology, Doctoral Supervisor, Taishan Scholars Climbing Program, Dean of Shandong University School of Clinical Medicine, Distinguished Professor, Ministry of Health, Outstanding Contributions, Young and Young Experts, Special Allowances from the State Council, Distinguished Experts, Standing Committee of the Hematology Branch of the Chinese Medical Doctor Association Member of the Society of Hematology, China Anti-Cancer Association, Hematology and Tumor Translational Medicine Branch, Vice Chairman, Shandong Medical Association, Hematology Branch, Chairman, Shandong Medical Association, Diagnostics Branch, Vice Chairman, Shandong Medical Association, Hematology Branch, American Society of Hematology, ASH Member ★ Scan the QR code below to enter the "Mystery Exploration" channel★Poke "Read the original text" and enter the "Mystery Exploration" channel!
Although the development rate is slower and the patient's survival period is longer, the patient usually cannot be completely cured
.
In recent years, the treatment of indolent B-cell lymphoma has gradually shifted from the optimization of treatment plans to the optimization of therapeutic drugs
.
New drugs led by a new generation of anti-CD20 monoclonal antibody otuzumab have shown better efficacy and safety in the treatment of indolent B-cell lymphoma, bringing more benefits to patients
.
In this regard, Yimaitong was fortunate to connect with Professor Wang Xin of Shandong Provincial Hospital to give a detailed explanation on the treatment progress of new drugs led by otuzumab in indolent B-cell lymphoma
.
Q1: First of all, could you please briefly introduce the current status of treatment of indolent B-cell lymphoma at home and abroad? Professor Wang Xin indolent B-cell lymphoma is a relatively common type of lymphoma, which develops slowly and is less aggressive
.
Patients with indolent B-cell lymphoma survive longer, and most patients survive for more than 10 years
.
But indolent B-cell lymphoma usually cannot be completely cured, and patients will experience repeated disease relapses
.
At present, some patients with relapsed indolent B-cell lymphoma, including follicular lymphoma (FL) patients with early disease progression, and patients with relapsed and refractory marginal zone lymphoma (MZL) still lack effective treatment options
.
In recent years, the treatment of indolent B-cell lymphoma has gradually shifted from the optimization of treatment plans to the optimization of therapeutic drugs
.
New drugs represented by the new generation of anti-CD20 monoclonal antibody otuzumab have demonstrated excellent efficacy and safety in indolent B-cell lymphoma
.
The emergence of many new drugs is expected to bring new changes to the treatment of indolent B-cell lymphoma
.
Q2: Could you please introduce the application status of otuzumab in indolent B-cell lymphoma? Professor Wang Xin Otuzumab is the world's first type II glycosylated humanized CD20 monoclonal antibody.
In the treatment of CD20-positive B-cell lymphoma, otuzumab is a new drug across the age
.
According to the currently reported data, otuzumab has achieved significant benefits in the treatment of indolent lymphoma
.
The GALLIUM study is a global multicenter, randomized controlled phase III clinical study that compared the efficacy of otuzumab (G) combined with chemotherapy and rituximab (R) combined with chemotherapy for induction treatment of newly treated FL patients
.
Compared with R-chemotherapy, G-chemotherapy reduces the risk of disease progression, recurrence and death by 34%, prolongs the time to next treatment (TTNT) by 28%, and reduces the risk of disease progression (POD24) by 46% within 24 months
.
The GADOLIN study is a global, multi-center, randomized controlled phase III clinical study.
FL patients with relapsed and refractory rituximab were enrolled to receive bendamustine monotherapy and otuzumab combined with benda.
Mustine (GB regimen) treatment
.
The results of the study show that compared with bendamustine single agent, the GB regimen has a significant effect
.
At a median follow-up of 31.
8 months, the risk of disease progression in the GB regimen was reduced by 43%, the median progression-free survival (PFS) was extended to 25.
8 months, and overall survival (OS) was significantly prolonged (P=0.
0269)
.
Whether it is initial treatment of FL or relapsed and refractory FL, the otuzumab combination program has shown excellent efficacy and provides a better treatment plan for FL patients
.
In addition to FL, otuzumab has also carried out related studies to observe the efficacy and safety of other indolent B-cell lymphomas
.
The CLL14 study showed that compared with the combination of otuzumab and chlorambucil, the combination of otuzumab and the Bcl-2 inhibitor venecla regimen can bring significant benefits to patients with chronic lymphocytic leukemia (CLL)
.
At a median follow-up of 39.
6 months, the 3-year PFS rate (81.
9% vs 49.
5%) of the combination of otuzumab and venecla regimen was higher, and the negative rate of peripheral blood minimal residual disease (MRD) 3 months after the end of treatment ( 75.
5% vs 35.
2%) and the MRD negative rate in the bone marrow (56.
9% vs 17.
1%) is also higher
.
In addition, compared with the regimen of otuzumab combined with chlorambucil, otuzumab combined with BTK inhibitor ibrutinib can be used in CLL or small lymphocyte lymph nodes with high risk factors (IGHV not mutated or TP53 abnormal).
Patients with tumor (SLL) also brought significant PFS benefits, with PFS rates at 30 months of 79% and 31%, respectively
.
Related real-world studies have also verified the efficacy of otuzumab
.
The GO-CLLEAR study included 63 CLL patients from 10 centers who were treated with otuzumab combined with chlorambucil regimen
.
The results of the study showed that the total response rate (ORR) of otuzumab combined with chlorambucil reached 76%, the complete response (CR) rate reached 30%, and the median event-free survival (EFS) was 49.
0 months.
.
The efficacy of the combination regimen of otuzumab in CLL patients in real-world studies is consistent with prospective clinical studies, which can bring better prognosis for CLL patients
.
Although CLL/SLL patients can obtain a better prognosis and longer survival through treatment with small molecule drugs such as BTK inhibitors, drug resistance is still a difficult problem in the treatment of CLL/SLL patients
.
In related studies, the associated combination of otuzumab has shown excellent efficacy and safety in CLL/SLL patients, and will provide more treatment options for CLL/SLL patients, and further improve the prognosis and quality of life of CLL/SLL patients
.
Q3: Otuzumab is also used in the treatment of other indolent B-cell lymphomas.
Can you introduce it? Professor Wang Xin Otuzumab has become one of the hotspots in the treatment of other indolent B-cell lymphomas.
Its mode of action includes induction of antibody-dependent cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and direct cell death (DCD)
.
Otuzumab combined with Ibrutinib and Venecla showed synergistic effects in preclinical models of mantle cell lymphoma
.
The phase I/II OAIs (NCT02558816) study aims to determine the maximum tolerated dose of venecola combined with fixed-dose ibrutinib and otuzumab in patients with relapsed mantle cell lymphoma (MCL), and at the same time for relapse and initial Open the extended cohort to treat patients to determine the safety and effectiveness of the program
.
The study enrolled 48 patients with MCL from October 14, 2015 to May 29, 2018
.
At the end of the sixth cycle of treatment, PET-CT assessed the CR rate of 86.
6% of patients with newly treated MCL, and the CR rate of patients with relapsed MCL was 67%
.
At a median follow-up of 17 months, the 2-year PFS rate of the combined regimen in patients with relapsed MCL was 69.
5%, and the 2-year OS rate was 68.
6%
.
At a median follow-up of 14 months, the 1-year PFS rate of the combined regimen in newly treated MCL patients was 93.
3%
.
The otuzumab combination regimen has shown considerable efficacy and good safety in patients with relapsed and refractory MCL.
For patients with relapsed and refractory MCL, especially rituximab-resistant relapsed and refractory MCL patients, Austria The combination of touzumab is expected to provide new treatment options
.
At various academic conferences in recent years, the combination of otuzumab and other drugs has shown excellent efficacy in the field of indolent lymphoma.
We look forward to the exploration of more therapeutic combinations in the future and the publication of larger sample research data
.
Q4: What do you think is the prospect of otuzumab in the treatment of other indolent lymphomas? Professor Wang Xin still has many unmet needs in patients receiving anti-CD20 therapy
.
Many patients will face problems such as repeated disease relapses, shortened duration of remission, and reduced quality of treatment
.
With the development of new anti-CD20 monoclonal antibodies, the understanding of the mechanisms of relapse and resistance continues to deepen, and new anti-CD20 monoclonal antibodies will bring more benefits to patients with indolent lymphoma
.
As a new type of humanized CD20 antibody, otuzumab may achieve better efficacy in more combination programs
.
Preclinical models of otuzumab combined with ibrutinib and veneclax in the preclinical model of MCL and preliminary data in the treatment of newly-treated MCL have shown good efficacy and safety; in CLL patients (CLL11) and rituximab Prolongation of OS has been observed in patients with refractory FL (GADOLIN)
.
Currently, otuzumab is combined with a variety of drugs, including BTK inhibitors, Bcl-2 inhibitors, immunomodulators and other related clinical studies are underway
.
Otuzumab has been on the market for more than two months in China, and many patients with indolent lymphoma in our department have also benefited from the use of otuzumab.
I believe that with the application of otuzumab in China, it will further improve The survival of lymphoma patients brings new hope to lymphoma patients
.
Professor Wang Xin Shandong Provincial Hospital, Director of the Department of Hematology, Doctoral Supervisor, Taishan Scholars Climbing Program, Dean of Shandong University School of Clinical Medicine, Distinguished Professor, Ministry of Health, Outstanding Contributions, Young and Young Experts, Special Allowances from the State Council, Distinguished Experts, Standing Committee of the Hematology Branch of the Chinese Medical Doctor Association Member of the Society of Hematology, China Anti-Cancer Association, Hematology and Tumor Translational Medicine Branch, Vice Chairman, Shandong Medical Association, Hematology Branch, Chairman, Shandong Medical Association, Diagnostics Branch, Vice Chairman, Shandong Medical Association, Hematology Branch, American Society of Hematology, ASH Member ★ Scan the QR code below to enter the "Mystery Exploration" channel★Poke "Read the original text" and enter the "Mystery Exploration" channel!
