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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 Professor Zhao Weilai's team from Ruijin Hospital, Shanghai Jiaotong University School of Medicine was selected for the Poster section of this year's ASH annual meeting.
The editor has compiled its main contents as follows for readers' reference
.
Research background Follicular lymphoma (FL) is a common subtype of indolent lymphoma, accounting for about 10% of all non-Hodgkin lymphomas (NHL)
.
FL patients generally respond well to first-line treatment, but most patients will relapse later, and as the number of treatment lines increases, the duration of remission (DOR) gradually decreases
.
For third-line and above FL patients, treatment options are limited, and repeated chemotherapy also greatly affects the patient's quality of life
.
In the United States, 4 PI3Kδ inhibitors are approved for adult patients with relapsed or refractory FL
.
Currently, China is conducting multiple trials of PI3K inhibitors for the treatment of relapsed/refractory FL, but none of the PI3K inhibitors has been approved
.
Parsaclisib is a potent, highly selective, new-generation PI3Kδ inhibitor, which has shown good efficacy and tolerability in patients with previously treated B-cell malignancies
.
Professor Zhao Weilai’s team conducted a multi-center, open-label Phase 2 study (CIBI376A201 study) to explore the efficacy of Parsaclisib in the treatment of patients with third-line FL in China
.
The interim results are published here for the reference of readers .
Research methods: Age ≥18 years, histologically confirmed FL level 1, 2 or 3a, previous ≥2 line systemic therapy, Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) ≥2, and not eligible for hematopoietic stem cells Patients with transplantation (HSCT) conditions can be considered for enrollment
.
The patient was assigned to receive Parsaclisib 20 mg once daily (QD) for 8 weeks and then 2.
5 mg QD until the disease progressed or an intolerable adverse event (AE) occurred or the study was withdrawn due to other reasons
.
Pneumocystis pneumonia (PJP) needs to be prevented
.
The primary endpoint is the objective response rate (ORR) assessed by the independent review committee (IRC), and the secondary endpoints include ORR, DOR, progression-free survival (PFS), overall survival (OS), and pharmacokinetics assessed by the investigator Features and safety and tolerability
.
Results of the study From April 2020 to April 11, 2021 (data cutoff), 36 patients received treatment
.
By the deadline, 5 patients (13.
9%) had stopped treatment due to disease progression
.
The median exposure time was 104 days (range 5-354 days)
.
The median age was 51 years, and 52.
8% of patients were male
.
The median time from initial diagnosis to enrollment was 3.
3 years
.
At admission, most (88.
9%) patients had ECOG PS ≤ 1, and 55.
6% of patients had Follicular Lymphoma International Prognostic Index score ≥ 3 (high risk)
.
All patients had previously received ≥2 line system therapy, and 22.
2% of patients had previously received ≥3 line system therapy
.
By the end of the data, 24 patients can be assessed for remission
.
According to the investigator's assessment, the ORR and complete response (CR) rates of all evaluable patients were 91.
7% (95% CI: 73%-99%) and 16.
7% (95% CI: 4.
7%-37.
4%), respectively
.
In patients in remission, the median DOR was not reached
.
Among the 36 patients with evaluable safety, the most common "treatment period" adverse events (TEAE) were decreased neutrophil count (36.
1%), decreased white blood cell count (16.
7%), and decreased platelet count (16.
7%) , Anemia (13.
9%), upper respiratory tract infection (11.
1%), elevated ALT (11.
1%) and diarrhea (11.
1%)
.
The most common grade ≥3 TEAEs are decreased neutrophil count (8.
3%), decreased platelet count (2.
8%), upper respiratory tract infection (2.
8%), and anemia (2.
8%)
.
22.
2% of patients discontinued the medication due to TEAE, and did not reduce the medication dose due to TEAE
.
There was no discontinuation of treatment due to TEAE
.
Severe TEAEs include upper respiratory tract infection (2.
8%), organ dysfunction (2.
8%), dizziness (2.
8%), and nasal mass (2.
8%), none of which are related to the study drug
.
One patient (2.
2%) died during the trial, and the researchers believed that it had nothing to do with the study drug
.
Research conclusions Parsaclisib shows good curative effect and good tolerability
.
These results indicate that Parsaclisib can bring huge benefits to third-line FL patients
.
Reference source: Zhong Zheng, et al.
2021 ASH.
Abstract #3536.
Stamp "read the original text" and we will make progress together
.
This year, the 63rd ASH Annual Conference will be held offline and online from December 11th to 14th
.
A study from Professor Zhao Weilai's team from Ruijin Hospital, Shanghai Jiaotong University School of Medicine was selected for the Poster section of this year's ASH annual meeting.
The editor has compiled its main contents as follows for readers' reference
.
Research background Follicular lymphoma (FL) is a common subtype of indolent lymphoma, accounting for about 10% of all non-Hodgkin lymphomas (NHL)
.
FL patients generally respond well to first-line treatment, but most patients will relapse later, and as the number of treatment lines increases, the duration of remission (DOR) gradually decreases
.
For third-line and above FL patients, treatment options are limited, and repeated chemotherapy also greatly affects the patient's quality of life
.
In the United States, 4 PI3Kδ inhibitors are approved for adult patients with relapsed or refractory FL
.
Currently, China is conducting multiple trials of PI3K inhibitors for the treatment of relapsed/refractory FL, but none of the PI3K inhibitors has been approved
.
Parsaclisib is a potent, highly selective, new-generation PI3Kδ inhibitor, which has shown good efficacy and tolerability in patients with previously treated B-cell malignancies
.
Professor Zhao Weilai’s team conducted a multi-center, open-label Phase 2 study (CIBI376A201 study) to explore the efficacy of Parsaclisib in the treatment of patients with third-line FL in China
.
The interim results are published here for the reference of readers .
Research methods: Age ≥18 years, histologically confirmed FL level 1, 2 or 3a, previous ≥2 line systemic therapy, Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) ≥2, and not eligible for hematopoietic stem cells Patients with transplantation (HSCT) conditions can be considered for enrollment
.
The patient was assigned to receive Parsaclisib 20 mg once daily (QD) for 8 weeks and then 2.
5 mg QD until the disease progressed or an intolerable adverse event (AE) occurred or the study was withdrawn due to other reasons
.
Pneumocystis pneumonia (PJP) needs to be prevented
.
The primary endpoint is the objective response rate (ORR) assessed by the independent review committee (IRC), and the secondary endpoints include ORR, DOR, progression-free survival (PFS), overall survival (OS), and pharmacokinetics assessed by the investigator Features and safety and tolerability
.
Results of the study From April 2020 to April 11, 2021 (data cutoff), 36 patients received treatment
.
By the deadline, 5 patients (13.
9%) had stopped treatment due to disease progression
.
The median exposure time was 104 days (range 5-354 days)
.
The median age was 51 years, and 52.
8% of patients were male
.
The median time from initial diagnosis to enrollment was 3.
3 years
.
At admission, most (88.
9%) patients had ECOG PS ≤ 1, and 55.
6% of patients had Follicular Lymphoma International Prognostic Index score ≥ 3 (high risk)
.
All patients had previously received ≥2 line system therapy, and 22.
2% of patients had previously received ≥3 line system therapy
.
By the end of the data, 24 patients can be assessed for remission
.
According to the investigator's assessment, the ORR and complete response (CR) rates of all evaluable patients were 91.
7% (95% CI: 73%-99%) and 16.
7% (95% CI: 4.
7%-37.
4%), respectively
.
In patients in remission, the median DOR was not reached
.
Among the 36 patients with evaluable safety, the most common "treatment period" adverse events (TEAE) were decreased neutrophil count (36.
1%), decreased white blood cell count (16.
7%), and decreased platelet count (16.
7%) , Anemia (13.
9%), upper respiratory tract infection (11.
1%), elevated ALT (11.
1%) and diarrhea (11.
1%)
.
The most common grade ≥3 TEAEs are decreased neutrophil count (8.
3%), decreased platelet count (2.
8%), upper respiratory tract infection (2.
8%), and anemia (2.
8%)
.
22.
2% of patients discontinued the medication due to TEAE, and did not reduce the medication dose due to TEAE
.
There was no discontinuation of treatment due to TEAE
.
Severe TEAEs include upper respiratory tract infection (2.
8%), organ dysfunction (2.
8%), dizziness (2.
8%), and nasal mass (2.
8%), none of which are related to the study drug
.
One patient (2.
2%) died during the trial, and the researchers believed that it had nothing to do with the study drug
.
Research conclusions Parsaclisib shows good curative effect and good tolerability
.
These results indicate that Parsaclisib can bring huge benefits to third-line FL patients
.
Reference source: Zhong Zheng, et al.
2021 ASH.
Abstract #3536.
Stamp "read the original text" and we will make progress together
