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Hi everyone, everyone
.
I’m Dr.
Zhu Huayuan from Jiangsu Provincial People’s Hospital.
Welcome to this issue of Lymphoma Microclass ASH for the first time
.
Today I bring you two abstracts of ASH
.
Abstract 640: Ibrutinib combined with FCR for long-term follow-up of a multi-center, phase II study of young newly diagnosed chronic lymphocytic leukemia.
The mutation status is unlimited
.
Ibrutinib 420 mg was administered daily for 7 days, and then Ibrutinib combined with FCR (iFCR) treatment for up to 6 cycles
.
Respondents continued to receive ibrutinib maintenance treatment.
After 2 years of maintenance treatment, the BM-uMRD patients discontinued the treatment
.
The primary endpoint is the CR/CRi rate of BM-uMRD 2 months after iFCR combination therapy
.
The secondary endpoints were to evaluate the response rate, PFS/OS, BM-uMRD rate, and safety/tolerability after 2 years of maintenance treatment with ibrutinib
.
Between October 2014 and April 2018, 9 U.
S.
research centers enrolled 85 patients
.
The median age is 55 years
.
IGHV was not mutated in 58.
2% of patients
.
Four and three patients had 17p deletion and TP53 mutation, respectively; two of them had both abnormalities
.
The median FCR treatment was 6 cycles
.
The ASH reported the study data with a median follow-up time of 40.
3 months
.
The median period of ibrutinib maintenance is 24 months
.
According to ITT analysis, the CR rate of BM-uMRD is 55% (47/85), and the best remission rate of BM-uMRD is still 84% (71/85)
.
After 2 years of maintenance treatment with ibrutinib, the CR/CRi rate, BM-uMRD rate and PB-uMRD rate were 77% (44/57), 81% (50/62) and 81% (55/68), respectively.
No matter whether IGHV is mutated or not, there is no difference in the results
.
At a median follow-up of 40 months, the PFS and OS of all patients were 97% and 99%, respectively
.
Of the 61 patients who completed the iFCR regimen and started ibrutinib maintenance treatment in the BM-uMRD state, 13 patients (21.
3%) had BM-MRD recurrence, but the median time to MRD recurrence had not yet been reached
.
Seven patients received ibrutinib single-agent retreatment (5 patients due to disease progression, 2 patients due to BM-MRD recurrence without disease progression) all reached PR
.
The median time for retreatment was 12.
8 months, and none of these 7 patients had disease progression during retreatment
.
The most common grade 3-4 adverse reactions caused by treatment are hematological toxicity, including neutropenia (40%), thrombocytopenia (32%) and anemia (11%)
.
10 patients developed febrile neutropenia ≥ grade 3, and 20 patients developed ≥ grade 3 infection
.
8% of patients had atrial fibrillation of any grade, and ventricular arrhythmia was observed in 1 patient
.
There were no major bleeding incidents
.
Two patients developed MDS, and both reached CR after receiving allogeneic hematopoietic stem cell transplantation
.
No patient developed Richter syndrome
.
The results of a long-term follow-up of 40.
3 months confirmed that most patients receiving iFCR treatment continued to maintain deep remissions, including patients without IGHV mutations
.
The safety is consistent with the toxicity of Ibrutinib and FCR alone
.
Among the few patients who relapsed after receiving this limited course of treatment, all patients responded to Ibrutinib single-agent retreatment
.
The iFCR treatment program provides the possibility for young, fit CLL patients to be cured through a limited course of treatment
.
Abstract 3734: Long-term follow-up results of ibrutinib monotherapy or combined with rituximab in the treatment of CLL patients with newly treated and relapsed/refractory TP53 abnormalities.
The study included 78 CLL patients with abnormal TP53
.
41 cases received Ibr monotherapy and 37 cases received Ibr+R treatment
.
27 cases were initial treatment, 51 cases were relapsed and refractory, and the median number of previous treatment lines was 2 lines
.
The median age is 65 years, 65% are male, 64% are IGHV unmutated, and 35% are Rai stage III-IV
.
With a median follow-up of 69 months, 21 patients are still participating in the study
.
The overall estimated median PFS is 72 months, and the median OS is not reached
.
The estimated 6-year PFS rate and OS rate are 47% and 72%, respectively
.
There was no significant difference in PFS and OS in patients receiving Ibr monotherapy and Ibr+R combination therapy (p=0.
7833)
.
The 6-year PFS rate for newly treated patients was 59.
3%, and for R/R patients was 41.
2%; OS rates were 79.
5% and 67.
4%, respectively
.
77 patients can be evaluated for remission, 40 patients in the Ibr group and 37 patients in the Ibr+R group
.
32.
5% achieved CR, 64.
9% achieved PR, 2 patients had stable disease, and ORR was 97.
4%
.
Among patients receiving Ibr monotherapy, 27.
5% achieved CR, 67.
5% achieved PR, 2 patients achieved SD, and ORR was 95.
0%
.
Among patients treated with Ibr+R, 37.
8% achieved CR (3 uMRD) and maintained CR during the study period, 62.
2% achieved PR, and ORR was 100%
.
The median time to CR for patients receiving Ibr monotherapy was 22 months, while the median time to CR for patients receiving Ibr+R treatment was 12 months
.
According to the subgroup analysis of patients based on the optimal depth of remission, there are significant differences in PFS, and CR is related to the prolongation of PFS in patients
.
Among the 57 patients who withdrew from the study (30 in the Ibr group and 27 in the Ibr+R group), the most common reasons for treatment termination were toxic side effects (n=14, 18%) and disease progression (n=14, 18%)
.
3 cases of Richter transformation
.
Other reasons for discontinuation of treatment included 10 cases changed to alternative treatment based on doctor's choice, and 6 cases died
.
From the long-term follow-up of the study for up to 6 years, it can be seen that high-risk CLL patients with abnormal TP53 treated with Ibrutinib can still obtain good survival benefits.
.
Moreover, first-line treatment with ibrutinib had better survival benefits, with a 6-year PFS rate of 59%, compared with 41% of R/R patients
.
Reaching CR is associated with longer PFS
.
This year's ASH, a treatment plan for CLL
.
There are also many articles about the combination of Ibrutinib and Venecla, and the combination of Venecla and Otuzumab
.
Please look forward to it .
This is the end of the Lymphoma Microclass
.
Thank you for watching .
Professor Zhu Huayuan, Doctor of Medicine, Deputy Chief Physician, Jiangsu Provincial People's Hospital, Associate Professor, Deputy Chairman of the Second Youth Committee of China Anti-Cancer Association Hematology Oncology Committee, Vice Chairman of CSCO Anti-Leukemia Alliance and Anti-Lymphoma Alliance Youth Committee, Jiangsu Research Hospital Association, Lymphoma Major Secretary-General of the Committee, Secretary of the Lymphoma and Myeloma Group of the Blood Branch of Jiangsu Medical Association, the 16th batch of "Six Top Talents" in Jiangsu Province 2011-2012 Yang Lulin School of Medicine, National University of Singapore and Singapore Cancer Science Institute Visiting Scholar 2016 7 Month-July 2017, Cleveland Medical Center in the United States for more than ten years of post-doctoral clinical work, familiar with the diagnosis and treatment of various hematological diseases, especially good at the standardized and individualized treatment of malignant lymphoma, chronic lymphocytic leukemia, and presided over the two National Natural Science Foundation of China.
Published nearly 20 papers in SCI and core journals.
CRC Number: MED-ONC-CN-2543 Approval date: 2021-11-12 stamp "Read the original", we make progress together
.
I’m Dr.
Zhu Huayuan from Jiangsu Provincial People’s Hospital.
Welcome to this issue of Lymphoma Microclass ASH for the first time
.
Today I bring you two abstracts of ASH
.
Abstract 640: Ibrutinib combined with FCR for long-term follow-up of a multi-center, phase II study of young newly diagnosed chronic lymphocytic leukemia.
The mutation status is unlimited
.
Ibrutinib 420 mg was administered daily for 7 days, and then Ibrutinib combined with FCR (iFCR) treatment for up to 6 cycles
.
Respondents continued to receive ibrutinib maintenance treatment.
After 2 years of maintenance treatment, the BM-uMRD patients discontinued the treatment
.
The primary endpoint is the CR/CRi rate of BM-uMRD 2 months after iFCR combination therapy
.
The secondary endpoints were to evaluate the response rate, PFS/OS, BM-uMRD rate, and safety/tolerability after 2 years of maintenance treatment with ibrutinib
.
Between October 2014 and April 2018, 9 U.
S.
research centers enrolled 85 patients
.
The median age is 55 years
.
IGHV was not mutated in 58.
2% of patients
.
Four and three patients had 17p deletion and TP53 mutation, respectively; two of them had both abnormalities
.
The median FCR treatment was 6 cycles
.
The ASH reported the study data with a median follow-up time of 40.
3 months
.
The median period of ibrutinib maintenance is 24 months
.
According to ITT analysis, the CR rate of BM-uMRD is 55% (47/85), and the best remission rate of BM-uMRD is still 84% (71/85)
.
After 2 years of maintenance treatment with ibrutinib, the CR/CRi rate, BM-uMRD rate and PB-uMRD rate were 77% (44/57), 81% (50/62) and 81% (55/68), respectively.
No matter whether IGHV is mutated or not, there is no difference in the results
.
At a median follow-up of 40 months, the PFS and OS of all patients were 97% and 99%, respectively
.
Of the 61 patients who completed the iFCR regimen and started ibrutinib maintenance treatment in the BM-uMRD state, 13 patients (21.
3%) had BM-MRD recurrence, but the median time to MRD recurrence had not yet been reached
.
Seven patients received ibrutinib single-agent retreatment (5 patients due to disease progression, 2 patients due to BM-MRD recurrence without disease progression) all reached PR
.
The median time for retreatment was 12.
8 months, and none of these 7 patients had disease progression during retreatment
.
The most common grade 3-4 adverse reactions caused by treatment are hematological toxicity, including neutropenia (40%), thrombocytopenia (32%) and anemia (11%)
.
10 patients developed febrile neutropenia ≥ grade 3, and 20 patients developed ≥ grade 3 infection
.
8% of patients had atrial fibrillation of any grade, and ventricular arrhythmia was observed in 1 patient
.
There were no major bleeding incidents
.
Two patients developed MDS, and both reached CR after receiving allogeneic hematopoietic stem cell transplantation
.
No patient developed Richter syndrome
.
The results of a long-term follow-up of 40.
3 months confirmed that most patients receiving iFCR treatment continued to maintain deep remissions, including patients without IGHV mutations
.
The safety is consistent with the toxicity of Ibrutinib and FCR alone
.
Among the few patients who relapsed after receiving this limited course of treatment, all patients responded to Ibrutinib single-agent retreatment
.
The iFCR treatment program provides the possibility for young, fit CLL patients to be cured through a limited course of treatment
.
Abstract 3734: Long-term follow-up results of ibrutinib monotherapy or combined with rituximab in the treatment of CLL patients with newly treated and relapsed/refractory TP53 abnormalities.
The study included 78 CLL patients with abnormal TP53
.
41 cases received Ibr monotherapy and 37 cases received Ibr+R treatment
.
27 cases were initial treatment, 51 cases were relapsed and refractory, and the median number of previous treatment lines was 2 lines
.
The median age is 65 years, 65% are male, 64% are IGHV unmutated, and 35% are Rai stage III-IV
.
With a median follow-up of 69 months, 21 patients are still participating in the study
.
The overall estimated median PFS is 72 months, and the median OS is not reached
.
The estimated 6-year PFS rate and OS rate are 47% and 72%, respectively
.
There was no significant difference in PFS and OS in patients receiving Ibr monotherapy and Ibr+R combination therapy (p=0.
7833)
.
The 6-year PFS rate for newly treated patients was 59.
3%, and for R/R patients was 41.
2%; OS rates were 79.
5% and 67.
4%, respectively
.
77 patients can be evaluated for remission, 40 patients in the Ibr group and 37 patients in the Ibr+R group
.
32.
5% achieved CR, 64.
9% achieved PR, 2 patients had stable disease, and ORR was 97.
4%
.
Among patients receiving Ibr monotherapy, 27.
5% achieved CR, 67.
5% achieved PR, 2 patients achieved SD, and ORR was 95.
0%
.
Among patients treated with Ibr+R, 37.
8% achieved CR (3 uMRD) and maintained CR during the study period, 62.
2% achieved PR, and ORR was 100%
.
The median time to CR for patients receiving Ibr monotherapy was 22 months, while the median time to CR for patients receiving Ibr+R treatment was 12 months
.
According to the subgroup analysis of patients based on the optimal depth of remission, there are significant differences in PFS, and CR is related to the prolongation of PFS in patients
.
Among the 57 patients who withdrew from the study (30 in the Ibr group and 27 in the Ibr+R group), the most common reasons for treatment termination were toxic side effects (n=14, 18%) and disease progression (n=14, 18%)
.
3 cases of Richter transformation
.
Other reasons for discontinuation of treatment included 10 cases changed to alternative treatment based on doctor's choice, and 6 cases died
.
From the long-term follow-up of the study for up to 6 years, it can be seen that high-risk CLL patients with abnormal TP53 treated with Ibrutinib can still obtain good survival benefits.
.
Moreover, first-line treatment with ibrutinib had better survival benefits, with a 6-year PFS rate of 59%, compared with 41% of R/R patients
.
Reaching CR is associated with longer PFS
.
This year's ASH, a treatment plan for CLL
.
There are also many articles about the combination of Ibrutinib and Venecla, and the combination of Venecla and Otuzumab
.
Please look forward to it .
This is the end of the Lymphoma Microclass
.
Thank you for watching .
Professor Zhu Huayuan, Doctor of Medicine, Deputy Chief Physician, Jiangsu Provincial People's Hospital, Associate Professor, Deputy Chairman of the Second Youth Committee of China Anti-Cancer Association Hematology Oncology Committee, Vice Chairman of CSCO Anti-Leukemia Alliance and Anti-Lymphoma Alliance Youth Committee, Jiangsu Research Hospital Association, Lymphoma Major Secretary-General of the Committee, Secretary of the Lymphoma and Myeloma Group of the Blood Branch of Jiangsu Medical Association, the 16th batch of "Six Top Talents" in Jiangsu Province 2011-2012 Yang Lulin School of Medicine, National University of Singapore and Singapore Cancer Science Institute Visiting Scholar 2016 7 Month-July 2017, Cleveland Medical Center in the United States for more than ten years of post-doctoral clinical work, familiar with the diagnosis and treatment of various hematological diseases, especially good at the standardized and individualized treatment of malignant lymphoma, chronic lymphocytic leukemia, and presided over the two National Natural Science Foundation of China.
Published nearly 20 papers in SCI and core journals.
CRC Number: MED-ONC-CN-2543 Approval date: 2021-11-12 stamp "Read the original", we make progress together
