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The annual American Society of Hematology (ASH) annual meeting is one of the largest and most comprehensive international academic conferences in the field of hematology in the world
.
This year, the 63rd ASH Annual Conference will be held offline and online from December 11th to 14th
.
A study from the team of Professor Zhou Daobin of Peking Union Medical College Hospital was selected for the Oral part of this year's ASH annual meeting.
The editor summarizes its main contents as follows for the reference of readers
.
Research background Waldenstrom's macroglobulinemia (WM) is a B-cell disease characterized by lymphoplasmacytic infiltration of the bone marrow, accompanied by IgM monoclonal gammaglobulinemia
.
Bruton's tyrosine kinase (BTK) plays a key role in the WM signaling pathway, especially in patients with the MYD88L265P mutation
.
However, due to the problem of target selectivity (off-target activity for many other kinases besides BTK), the clinical application of early BTK inhibitors is still affected
.
Orelabrutinib is a new and highly effective small molecule BTK inhibitor with excellent selectivity for B cell malignancies and autoimmune diseases.
This article introduces Orelabrutinib for relapsed/refractory WM Preliminary efficacy and safety data for patients
.
Research Method The ICP-CL-00105 study is a single-arm, multi-center, open-label Phase 2 study.
The subjects are clinically and histopathologically confirmed patients with relapsed/refractory WM (according to IWWM-7 criteria)
.
MYD88 and CXCR4 mutations were evaluated in bone marrow samples at baseline
.
The daily dose of Obutinib is 150 mg, which is administered orally until disease progression or intolerable toxicity
.
IgM assessment of blood samples was performed at baseline and every cycle, and after 6 cycles, every 3 cycles
.
Assess mitigation according to IWWM-6 and NCCN guidelines
.
The primary endpoint is the primary response rate (MRR) assessed by the IRC, and the primary and secondary endpoints are the investigator-assessed MRR, overall response rate (ORR), duration of primary response (DOMR), progression-free survival (PFS), overall survival Period (OS), changes in IgM levels, improvement in hemoglobin levels, and safety
.
According to NCI CTCAE v4.
03 to evaluate "treatment period" adverse events (TEAE) and treatment-related adverse events (TRAE)
.
The results of the study as of June 1, 2021, 47 patients were followed up for a median of 10.
5 months
.
The median age was 63 years (range 56-68 years), and 40 patients (85.
1%) were men
.
According to the International Prognostic Scoring System (IPSS), 87.
2% of patients are at medium or high risk
.
At baseline, the proportion of patients with MYD88L265P and CXCR4 wild type was 83%
.
The median time of treatment was 9.
2 months, the investigator's estimated MRR was 74.
5%, ORR was 87.
2%, and 97.
9% of patients had disease control
.
The estimated 12-month DOMR rate is 89.
5%, and the estimated 12-month PFS rate and OS rate are 88.
0% and 92.
3%, respectively
.
The median PFS and OS have not yet been reached
.
MYD88L265P and CXCR4 wild-type patients had a higher MRR (79.
5%)
.
The median IgM level at baseline was 30.
3g/L, and the serum IgM level decreased from baseline, with a median decrease of 79.
0% (IQR: -89.
4, -57.
2)
.
The median hemoglobin level at baseline was 102g/L, 83% of patients had a lasting improvement in hemoglobin level, and the median maximum improvement was 40g/L (IQR: 24.
0, 62.
0)
.
The safety data is summarized according to the deadline of June 1, 2021
.
The most common AEs are thrombocytopenia (27.
7%), neutropenia (14.
9%), leukopenia (10.
6%), upper respiratory tract infection (14.
9%), weight gain (14.
9%), influenza-like illness (12.
8%) ) And rash (10.
6%)
.
The majority of AEs (89.
5%) were grade 1-2
.
Sixteen patients (34.
0%) had a grade ≥3 TEAE, and 9 patients (19.
1%) had a grade ≥3 TEAE
.
There is no atrial fibrillation and/or atrial flutter of grade ≥3 or diarrhea of grade ≥3
.
Only one case of TRAE (2.
1%) resulted in drug discontinuation
.
Research conclusions During the short-term follow-up, abutinib showed excellent efficacy in the treatment of patients with relapsed/refractory WM
.
It shows good safety and tolerability, and has limited off-target adverse reactions
.
It may become a promising treatment option for patients with relapsed/refractory WM
.
Reference source: Daobin Zhou, et al.
2021 ASH.
Abstract #46.
Stamp "read the original text", we make progress together
.
This year, the 63rd ASH Annual Conference will be held offline and online from December 11th to 14th
.
A study from the team of Professor Zhou Daobin of Peking Union Medical College Hospital was selected for the Oral part of this year's ASH annual meeting.
The editor summarizes its main contents as follows for the reference of readers
.
Research background Waldenstrom's macroglobulinemia (WM) is a B-cell disease characterized by lymphoplasmacytic infiltration of the bone marrow, accompanied by IgM monoclonal gammaglobulinemia
.
Bruton's tyrosine kinase (BTK) plays a key role in the WM signaling pathway, especially in patients with the MYD88L265P mutation
.
However, due to the problem of target selectivity (off-target activity for many other kinases besides BTK), the clinical application of early BTK inhibitors is still affected
.
Orelabrutinib is a new and highly effective small molecule BTK inhibitor with excellent selectivity for B cell malignancies and autoimmune diseases.
This article introduces Orelabrutinib for relapsed/refractory WM Preliminary efficacy and safety data for patients
.
Research Method The ICP-CL-00105 study is a single-arm, multi-center, open-label Phase 2 study.
The subjects are clinically and histopathologically confirmed patients with relapsed/refractory WM (according to IWWM-7 criteria)
.
MYD88 and CXCR4 mutations were evaluated in bone marrow samples at baseline
.
The daily dose of Obutinib is 150 mg, which is administered orally until disease progression or intolerable toxicity
.
IgM assessment of blood samples was performed at baseline and every cycle, and after 6 cycles, every 3 cycles
.
Assess mitigation according to IWWM-6 and NCCN guidelines
.
The primary endpoint is the primary response rate (MRR) assessed by the IRC, and the primary and secondary endpoints are the investigator-assessed MRR, overall response rate (ORR), duration of primary response (DOMR), progression-free survival (PFS), overall survival Period (OS), changes in IgM levels, improvement in hemoglobin levels, and safety
.
According to NCI CTCAE v4.
03 to evaluate "treatment period" adverse events (TEAE) and treatment-related adverse events (TRAE)
.
The results of the study as of June 1, 2021, 47 patients were followed up for a median of 10.
5 months
.
The median age was 63 years (range 56-68 years), and 40 patients (85.
1%) were men
.
According to the International Prognostic Scoring System (IPSS), 87.
2% of patients are at medium or high risk
.
At baseline, the proportion of patients with MYD88L265P and CXCR4 wild type was 83%
.
The median time of treatment was 9.
2 months, the investigator's estimated MRR was 74.
5%, ORR was 87.
2%, and 97.
9% of patients had disease control
.
The estimated 12-month DOMR rate is 89.
5%, and the estimated 12-month PFS rate and OS rate are 88.
0% and 92.
3%, respectively
.
The median PFS and OS have not yet been reached
.
MYD88L265P and CXCR4 wild-type patients had a higher MRR (79.
5%)
.
The median IgM level at baseline was 30.
3g/L, and the serum IgM level decreased from baseline, with a median decrease of 79.
0% (IQR: -89.
4, -57.
2)
.
The median hemoglobin level at baseline was 102g/L, 83% of patients had a lasting improvement in hemoglobin level, and the median maximum improvement was 40g/L (IQR: 24.
0, 62.
0)
.
The safety data is summarized according to the deadline of June 1, 2021
.
The most common AEs are thrombocytopenia (27.
7%), neutropenia (14.
9%), leukopenia (10.
6%), upper respiratory tract infection (14.
9%), weight gain (14.
9%), influenza-like illness (12.
8%) ) And rash (10.
6%)
.
The majority of AEs (89.
5%) were grade 1-2
.
Sixteen patients (34.
0%) had a grade ≥3 TEAE, and 9 patients (19.
1%) had a grade ≥3 TEAE
.
There is no atrial fibrillation and/or atrial flutter of grade ≥3 or diarrhea of grade ≥3
.
Only one case of TRAE (2.
1%) resulted in drug discontinuation
.
Research conclusions During the short-term follow-up, abutinib showed excellent efficacy in the treatment of patients with relapsed/refractory WM
.
It shows good safety and tolerability, and has limited off-target adverse reactions
.
It may become a promising treatment option for patients with relapsed/refractory WM
.
Reference source: Daobin Zhou, et al.
2021 ASH.
Abstract #46.
Stamp "read the original text", we make progress together
