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Hello everyone, welcome to the [Lymphoma Microclass], I am Dr.
Jing Hongmei from Peking University Third Hospital.
The European Hematology Annual Conference is the largest international conference in the field of hematology in Europe.
It is planned to be held from June 9th to 17th this year.
Today, I will share with you an abstract reported at this year's European Hematology Annual Meeting, the final analysis of the 5-year follow-up of Ibrutinib combined with rituximab in the treatment of Waldenstrom's macroglobulinemia.
Research background Ibrutinib is the first approved BTK (Bruton's tyrosine kinase) inhibitor.
It is administered orally once a day and has been approved as a single agent or combined with rituximab to treat all lines of initial treatment or relapse Of patients with Waldenstrom's macroglobulinemia.
The preliminary analysis of the phase III INNOVATE study with a median follow-up of 26.
5 months confirmed that the progression-free survival (PFS) of ibrutinib combined with rituximab was better than placebo combined with rituximab in the treatment of patients with Waldenstrom's macroglobulinemia Monoclonal antibody group.
This summary reports the final analysis results of the 5-year follow-up of the INNOVATE study.
The research method diagnosed patients with Symptomatic Waldenstrom's macroglobulinemia were randomly assigned to two groups, 75 patients in each group, and one group received ibrutinib 420 mg + R (375 mg/m2/week IV) once a day , Weeks 1-4 and Weeks 17-20), the other group received placebo + R (375 mg/m2/week IV, Weeks 1-4 and Weeks 17-20).
The enrolled patients can be treated for the first time or patients who have received treatment in the past; patients who have received R treatment in the past, the last time based on the R treatment plan achieved at least a slight remission (MR).
Endpoints include PFS and remission rate, overall survival (OS), hemoglobin (Hgb) improvement, time to next treatment (TTNT), and safety assessed by the independent review board.
Changes in serum IgM were also evaluated.
The results of the study were balanced in patient characteristics between the two groups.
After a median follow-up of 50 months (range 0.
5 + to 63), the ibrutinib combined with rituximab group did not achieve the median PFS (NR; 95% CI 57.
7 months to be unpredictable), and the R+ placebo group was 20.
3 months (95%CI13.
0−27.
6) (hazard ratio [HR] 0.
25[0.
15−0.
42]; P <0.
0001) (figure); 54-month PFS rate was 68% vs 25% (IR vsR).
PFS benefit of ibrutinib combined with rituximab vs R and previous treatment status (HR[95%CI]: first-line, 0.
32[0.
14−0.
70]; previous treatment, 0.
22[0.
11−0.
43]) or genotype (HR[95%CI]: MYD88L265P/CXCR4WT, 0.
18[0.
08−0.
43]; MYD88L265P/CXCR4WHIM, 0.
27[0.
12−0.
62]; MYD88WT/CXCR4WT, 0.
29[0.
07−1.
19]) irrelevant.
In pre-specified subgroups (including age, serum IgM, Hgb, IPSS Fahrenheit macroglobulinemia, and MYD88 mutation status), it was observed that the IR group increased PFS.
The main remission rate (≥ partial remission) of ibrutinib combined with rituximab increased and continued over time, reaching 76% vs 31% of R (P <0.
0001); the total remission rate (≥MR) was 92% vs 44% (P <0.
0001).
The proportion of patients in the IR group who achieved continuous improvement in Hgb was higher than that in the R group (77% vs 43%; P <0.
0001).
IgM decreased rapidly in the first year.
Ibrutinib combined with rituximab (56mo) decreased by 33.
5 g/L at most, and R (57mo) decreased by 26.
9 g/L at most.
The median OS was not reached in the two groups; the 54-month OS rate of the ibrutinib combined with rituximab group was 86%, and that of the R group was 84%.
The median TTNT ibrutinib combined with rituximab did not reach 18 months in the R group; 87% of the IR group did not receive follow-up treatment at 54 months, while 71% of the R group received follow-up treatment.
Thirty-five patients (47%) who received R treatment crossed over to the ibrutinib monotherapy group after disease progression.
The safety of ibrutinib combined with rituximab is consistent with previous reports.
The incidence of AEs of clinical concern ≥3 in the IR group generally decreased over time.
12 cases of grade 3-4 atrial fibrillation occurred, of which 9 cases (75%) were still receiving treatment; there were no other patients who discontinued ibrutinib treatment due to common (≥10%) grade 3-4 adverse reactions.
88% of AEs resulted in a dose reduction of Ibrutinib, and the AEs resolved after the dose was reduced.
After the study, 68 patients (45%) were still receiving treatment.
Conclusion After a follow-up period of up to 5 years, ibrutinib combined with rituximab showed the continued effectiveness of various clinical outcomes in patients with Waldenstrom's macroglobulinemia, which was related to genotype, previous treatment and key patient characteristics.
Irrelevant.
A similar response pattern was observed in the combination of ibrutinib and rituximab in first-line treatment and in patients who have received previous treatment.
No new safety signals were observed; in the subsequent 24 months of follow-up, Ibrutinib combined with rituximab maintained a controllable safety profile.
Waldenstrom's macroglobulinemia is a rare type of B-lymphocyte tumor, and patients will have clinical manifestations such as anemia, fatigue, and night sweats.
In recent years, the research on the pathogenesis, diagnosis and treatment of Waldenstrom's macroglobulinemia has made great progress.
With the advancement of medicine, breakthroughs have been made in the treatment of Waldenstrom's macroglobulinemia, which has developed from traditional immunochemotherapy to the era of targeted drug therapy.
The survival period of most patients can be extended to more than ten years.
Due to the different clinical manifestations and the rarity of the disease, the first-line treatment options for Waldenstrom's macroglobulinemia are widely heterogeneous.
Targeted drug BTK (Bruton's tyrosine kinase) inhibitors can be used to treat patients with Waldenstrom's macroglobulinemia of different genotypes and treatment states to achieve deep relief.
In the U.
S.
NCCN guidelines updated at the end of 2020, Ibrutinib is the recommended treatment plan for newly-treated and refractory or relapsed Waldenstrom's macroglobulinemia patients.
As the first approved oral BTK inhibitor in China, Ibritinib was approved in 2018 for the treatment of Fahrenheit's macroglobulinemia, and the treatment plan for this indication was officially included in the National Medical Insurance List in 2020.
The price drop can reach 85%.
With the official landing of the new version of the National Medical Insurance Catalogue in March this year, the inclusion of Ibrutinib has broadened the choice of medication for patients and effectively reduced the burden on patients.
This is the end of this lymphoma micro-class, thank you everyone! Professor Jing Hongmei, Director of the Department of Hematology, Peking University Third Hospital; Professor, Chief Physician, Doctoral Supervisor; Visiting Scholar at Toyama Medical and Pharmaceutical University in Japan in 2000, MD Anderson Cancer Center in the United States in 2007, and University of Nebraska in 2012 ; Has presided over and participated in the National Natural Science Foundation of China, Beijing Natural Science Foundation, Peking University Cancer Research Center "985 Multi-center Research", 211 Fund and other research funds, and won the University Scientific Research Outstanding Achievement Award (Science and Technology) ) Second prize of Science and Technology Progress Award; published more than 60 papers and participated in the compilation and translation of 5 works.
Current medical technology appraisal consultant in Beijing and Haidian District; member of the Diagnostics Group of the Blood Branch of the Chinese Medical Association, member of the Radiation Hematology Group of the Chinese Society of Radiological Medicine and Protection, deputy director of the Lymphoma Branch of the Chinese Medical Education Association, and oncology of the Chinese Association of Women Physicians Member of the Scientific Expert Committee, Chairman of the Oncology Youth Committee of the Chinese Women Physicians Association, member of the Geriatric Oncology Committee of the Chinese Society of Gerontology, and member of the National Youth Committee of the Lymphoma Professional Committee of the Chinese Anti-Cancer Association
CRC Number: MED-ONC-CN-2139 Approved date: 2021-05-18 stamp "read the original text", we make progress together
Jing Hongmei from Peking University Third Hospital.
The European Hematology Annual Conference is the largest international conference in the field of hematology in Europe.
It is planned to be held from June 9th to 17th this year.
Today, I will share with you an abstract reported at this year's European Hematology Annual Meeting, the final analysis of the 5-year follow-up of Ibrutinib combined with rituximab in the treatment of Waldenstrom's macroglobulinemia.
Research background Ibrutinib is the first approved BTK (Bruton's tyrosine kinase) inhibitor.
It is administered orally once a day and has been approved as a single agent or combined with rituximab to treat all lines of initial treatment or relapse Of patients with Waldenstrom's macroglobulinemia.
The preliminary analysis of the phase III INNOVATE study with a median follow-up of 26.
5 months confirmed that the progression-free survival (PFS) of ibrutinib combined with rituximab was better than placebo combined with rituximab in the treatment of patients with Waldenstrom's macroglobulinemia Monoclonal antibody group.
This summary reports the final analysis results of the 5-year follow-up of the INNOVATE study.
The research method diagnosed patients with Symptomatic Waldenstrom's macroglobulinemia were randomly assigned to two groups, 75 patients in each group, and one group received ibrutinib 420 mg + R (375 mg/m2/week IV) once a day , Weeks 1-4 and Weeks 17-20), the other group received placebo + R (375 mg/m2/week IV, Weeks 1-4 and Weeks 17-20).
The enrolled patients can be treated for the first time or patients who have received treatment in the past; patients who have received R treatment in the past, the last time based on the R treatment plan achieved at least a slight remission (MR).
Endpoints include PFS and remission rate, overall survival (OS), hemoglobin (Hgb) improvement, time to next treatment (TTNT), and safety assessed by the independent review board.
Changes in serum IgM were also evaluated.
The results of the study were balanced in patient characteristics between the two groups.
After a median follow-up of 50 months (range 0.
5 + to 63), the ibrutinib combined with rituximab group did not achieve the median PFS (NR; 95% CI 57.
7 months to be unpredictable), and the R+ placebo group was 20.
3 months (95%CI13.
0−27.
6) (hazard ratio [HR] 0.
25[0.
15−0.
42]; P <0.
0001) (figure); 54-month PFS rate was 68% vs 25% (IR vsR).
PFS benefit of ibrutinib combined with rituximab vs R and previous treatment status (HR[95%CI]: first-line, 0.
32[0.
14−0.
70]; previous treatment, 0.
22[0.
11−0.
43]) or genotype (HR[95%CI]: MYD88L265P/CXCR4WT, 0.
18[0.
08−0.
43]; MYD88L265P/CXCR4WHIM, 0.
27[0.
12−0.
62]; MYD88WT/CXCR4WT, 0.
29[0.
07−1.
19]) irrelevant.
In pre-specified subgroups (including age, serum IgM, Hgb, IPSS Fahrenheit macroglobulinemia, and MYD88 mutation status), it was observed that the IR group increased PFS.
The main remission rate (≥ partial remission) of ibrutinib combined with rituximab increased and continued over time, reaching 76% vs 31% of R (P <0.
0001); the total remission rate (≥MR) was 92% vs 44% (P <0.
0001).
The proportion of patients in the IR group who achieved continuous improvement in Hgb was higher than that in the R group (77% vs 43%; P <0.
0001).
IgM decreased rapidly in the first year.
Ibrutinib combined with rituximab (56mo) decreased by 33.
5 g/L at most, and R (57mo) decreased by 26.
9 g/L at most.
The median OS was not reached in the two groups; the 54-month OS rate of the ibrutinib combined with rituximab group was 86%, and that of the R group was 84%.
The median TTNT ibrutinib combined with rituximab did not reach 18 months in the R group; 87% of the IR group did not receive follow-up treatment at 54 months, while 71% of the R group received follow-up treatment.
Thirty-five patients (47%) who received R treatment crossed over to the ibrutinib monotherapy group after disease progression.
The safety of ibrutinib combined with rituximab is consistent with previous reports.
The incidence of AEs of clinical concern ≥3 in the IR group generally decreased over time.
12 cases of grade 3-4 atrial fibrillation occurred, of which 9 cases (75%) were still receiving treatment; there were no other patients who discontinued ibrutinib treatment due to common (≥10%) grade 3-4 adverse reactions.
88% of AEs resulted in a dose reduction of Ibrutinib, and the AEs resolved after the dose was reduced.
After the study, 68 patients (45%) were still receiving treatment.
Conclusion After a follow-up period of up to 5 years, ibrutinib combined with rituximab showed the continued effectiveness of various clinical outcomes in patients with Waldenstrom's macroglobulinemia, which was related to genotype, previous treatment and key patient characteristics.
Irrelevant.
A similar response pattern was observed in the combination of ibrutinib and rituximab in first-line treatment and in patients who have received previous treatment.
No new safety signals were observed; in the subsequent 24 months of follow-up, Ibrutinib combined with rituximab maintained a controllable safety profile.
Waldenstrom's macroglobulinemia is a rare type of B-lymphocyte tumor, and patients will have clinical manifestations such as anemia, fatigue, and night sweats.
In recent years, the research on the pathogenesis, diagnosis and treatment of Waldenstrom's macroglobulinemia has made great progress.
With the advancement of medicine, breakthroughs have been made in the treatment of Waldenstrom's macroglobulinemia, which has developed from traditional immunochemotherapy to the era of targeted drug therapy.
The survival period of most patients can be extended to more than ten years.
Due to the different clinical manifestations and the rarity of the disease, the first-line treatment options for Waldenstrom's macroglobulinemia are widely heterogeneous.
Targeted drug BTK (Bruton's tyrosine kinase) inhibitors can be used to treat patients with Waldenstrom's macroglobulinemia of different genotypes and treatment states to achieve deep relief.
In the U.
S.
NCCN guidelines updated at the end of 2020, Ibrutinib is the recommended treatment plan for newly-treated and refractory or relapsed Waldenstrom's macroglobulinemia patients.
As the first approved oral BTK inhibitor in China, Ibritinib was approved in 2018 for the treatment of Fahrenheit's macroglobulinemia, and the treatment plan for this indication was officially included in the National Medical Insurance List in 2020.
The price drop can reach 85%.
With the official landing of the new version of the National Medical Insurance Catalogue in March this year, the inclusion of Ibrutinib has broadened the choice of medication for patients and effectively reduced the burden on patients.
This is the end of this lymphoma micro-class, thank you everyone! Professor Jing Hongmei, Director of the Department of Hematology, Peking University Third Hospital; Professor, Chief Physician, Doctoral Supervisor; Visiting Scholar at Toyama Medical and Pharmaceutical University in Japan in 2000, MD Anderson Cancer Center in the United States in 2007, and University of Nebraska in 2012 ; Has presided over and participated in the National Natural Science Foundation of China, Beijing Natural Science Foundation, Peking University Cancer Research Center "985 Multi-center Research", 211 Fund and other research funds, and won the University Scientific Research Outstanding Achievement Award (Science and Technology) ) Second prize of Science and Technology Progress Award; published more than 60 papers and participated in the compilation and translation of 5 works.
Current medical technology appraisal consultant in Beijing and Haidian District; member of the Diagnostics Group of the Blood Branch of the Chinese Medical Association, member of the Radiation Hematology Group of the Chinese Society of Radiological Medicine and Protection, deputy director of the Lymphoma Branch of the Chinese Medical Education Association, and oncology of the Chinese Association of Women Physicians Member of the Scientific Expert Committee, Chairman of the Oncology Youth Committee of the Chinese Women Physicians Association, member of the Geriatric Oncology Committee of the Chinese Society of Gerontology, and member of the National Youth Committee of the Lymphoma Professional Committee of the Chinese Anti-Cancer Association
CRC Number: MED-ONC-CN-2139 Approved date: 2021-05-18 stamp "read the original text", we make progress together
