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Otuzumab is a newly approved anti-CD20 monoclonal antibody that can be used in the first-line treatment of follicular lymphoma (FL)
.
For the initial use of new drugs, I believe that apart from paying attention to the efficacy of the drugs, the experts are also particularly concerned about the safety of the drugs
.
According to the instructions for use of otuzumab1, otuzumab is administered by intravenous infusion, each infusion of 1000mg, the time is about 3-4 hours
.
The main factor affecting the infusion rate is the infusion-related reaction (IRR)
.
In 2012, the U.
S.
Food and Drug Administration (FDA) approved a rapid intravenous infusion (90 min) of rituximab (trade name: Rituxan) for the second cycle and subsequent courses2
.
So is it safe to start short-term infusion of otuzumab in cycle 2 (C2)? Today, the editor will share with experts the results of the “GAZELLE” study of short duration infusion (SDI) of Otuzumab announced at the ASCO3 and EHA4 conferences this year
.
Research method GAZELLE is an international, open-ended Phase IV study (NCT03817853) conducted in previously untreated FL patients
.
It mainly evaluated the safety of 90-minute short-term infusion (SDI) of Otuzumab in FL patients starting from C2
.
The main research methods are shown in Figure 1
.
The primary study endpoint is the incidence of C2≥3 grade IRR, and other secondary endpoints include: safety, remission rate, progression-free survival (PFS) and overall survival (OS)
.
Figure 1 GAZELLE study design study results As of December 3, 2020, a total of 113 patients have received study treatment
.
The baseline characteristics of the patient are shown in Figure 2
.
The median age of the patients was 62 years, 92% of patients were in stage III/IV, and 81.
4% were classified as intermediate-risk or high-risk groups
.
The patient’s induction therapy regimen was: GB regimen (45.
1%), G-CHOP regimen (38.
1%), and G-CVP regimen (16.
8%)
.
Figure 2 Baseline characteristics of patients 1 Safety of treatment No new safety signals have been reported
.
See Figure 3 for the patients with IRR (%) listed by cycle and grade
.
AEs that occurred more than 30% during induction therapy: neutropenia (61.
1%), IRR (61.
1%), nausea (41.
6%), and constipation (35.
4%)
.
AEs of grade 3-5 during induction therapy: neutropenia (49.
6%), leukopenia (11.
5%), lymphopenia (10.
6%), thrombocytopenia (7.
1%), IRR (6.
2%), atrial fibrillation (5.
3%) When IRR occurred: Most IRR occurred during C1
.
The IRR that occurred during C2 accounted for 11.
8% (10.
0% for grade 1 and 1.
8% for grade 2)
.
In the cycle after C2, only one patient who received short-term infusion of Otuzumab developed Grade 3 IRR
.
The severity of the occurrence of IRR: 6.
2% (7/113) of the patients had grade 3 IRR during the study period
.
No Level 4 or Level 5 IRR was reported
.
Figure 3 Patients with IRR (%) listed by cycle and grade.
2 Therapeutic efficacy This study treated patients who underwent PET-CT/CT assessment at the end of induction therapy (EOI) according to Lugano2014, Cheson 2007 or Cheson1999 criteria Response assessment showed that 76/113 patients (67.
3%) had complete remission (CR), 22 (19.
5%) patients had partial remission (PR), and 6 patients (5.
8%) had disease progression (PD)
.
See Figure 4
.
Figure 4 Treatment response rate evaluated by investigators at the end of induction therapy (EOI).
Conclusions In the GAZELLE study, short-term infusion of otuzumab for C2 and later courses seemed to be safe
.
No level 3 IRR was observed in C2, and only one case of level 3 IRR was reported in the subsequent cycle
.
No new safety signals have been reported for short-term infusion of otuzumab, and the therapeutic response to the end of induction therapy is consistent with previous studies
.
Short-term infusion of otuzumab may improve patient convenience and infusion efficiency
.
GALLIUM study 5, the key study in which otuzumab was approved, confirmed the safety of the otuzumab treatment group for FL patients
.
The GAZELLE study confirmed the safety and convenience of a 90-minute short-term infusion (SDI) of Otuzumab for FL patients starting from C2
.
Although Otuzumab has been on the market in the United States for 8 years, it has just been marketed in China, and experts have little experience in clinical medication
.
It is believed that based on the rich experience in the application of rituximab accumulated over the past 20 years, the continuous increase in the use of otuzumab, and the continuous improvement of the safety management level of otuzumab, Chinese experts will consider otuzumab It is better applied to patients with follicular lymphoma to achieve the goal of good medicinal use
.
References 1.
Instructions for otuzumab injection 2.
NCCN Guidelines for B-cell Lymphoma, 2021 first edition 3.
2021 ASCO conference abstract number: 75454.
2021 EHA conference abstract number: EP8075.
Marcus R, et al .
N EngJ Med 2017;377:1331‒44 stamp "Read the original", we make progress together
.
For the initial use of new drugs, I believe that apart from paying attention to the efficacy of the drugs, the experts are also particularly concerned about the safety of the drugs
.
According to the instructions for use of otuzumab1, otuzumab is administered by intravenous infusion, each infusion of 1000mg, the time is about 3-4 hours
.
The main factor affecting the infusion rate is the infusion-related reaction (IRR)
.
In 2012, the U.
S.
Food and Drug Administration (FDA) approved a rapid intravenous infusion (90 min) of rituximab (trade name: Rituxan) for the second cycle and subsequent courses2
.
So is it safe to start short-term infusion of otuzumab in cycle 2 (C2)? Today, the editor will share with experts the results of the “GAZELLE” study of short duration infusion (SDI) of Otuzumab announced at the ASCO3 and EHA4 conferences this year
.
Research method GAZELLE is an international, open-ended Phase IV study (NCT03817853) conducted in previously untreated FL patients
.
It mainly evaluated the safety of 90-minute short-term infusion (SDI) of Otuzumab in FL patients starting from C2
.
The main research methods are shown in Figure 1
.
The primary study endpoint is the incidence of C2≥3 grade IRR, and other secondary endpoints include: safety, remission rate, progression-free survival (PFS) and overall survival (OS)
.
Figure 1 GAZELLE study design study results As of December 3, 2020, a total of 113 patients have received study treatment
.
The baseline characteristics of the patient are shown in Figure 2
.
The median age of the patients was 62 years, 92% of patients were in stage III/IV, and 81.
4% were classified as intermediate-risk or high-risk groups
.
The patient’s induction therapy regimen was: GB regimen (45.
1%), G-CHOP regimen (38.
1%), and G-CVP regimen (16.
8%)
.
Figure 2 Baseline characteristics of patients 1 Safety of treatment No new safety signals have been reported
.
See Figure 3 for the patients with IRR (%) listed by cycle and grade
.
AEs that occurred more than 30% during induction therapy: neutropenia (61.
1%), IRR (61.
1%), nausea (41.
6%), and constipation (35.
4%)
.
AEs of grade 3-5 during induction therapy: neutropenia (49.
6%), leukopenia (11.
5%), lymphopenia (10.
6%), thrombocytopenia (7.
1%), IRR (6.
2%), atrial fibrillation (5.
3%) When IRR occurred: Most IRR occurred during C1
.
The IRR that occurred during C2 accounted for 11.
8% (10.
0% for grade 1 and 1.
8% for grade 2)
.
In the cycle after C2, only one patient who received short-term infusion of Otuzumab developed Grade 3 IRR
.
The severity of the occurrence of IRR: 6.
2% (7/113) of the patients had grade 3 IRR during the study period
.
No Level 4 or Level 5 IRR was reported
.
Figure 3 Patients with IRR (%) listed by cycle and grade.
2 Therapeutic efficacy This study treated patients who underwent PET-CT/CT assessment at the end of induction therapy (EOI) according to Lugano2014, Cheson 2007 or Cheson1999 criteria Response assessment showed that 76/113 patients (67.
3%) had complete remission (CR), 22 (19.
5%) patients had partial remission (PR), and 6 patients (5.
8%) had disease progression (PD)
.
See Figure 4
.
Figure 4 Treatment response rate evaluated by investigators at the end of induction therapy (EOI).
Conclusions In the GAZELLE study, short-term infusion of otuzumab for C2 and later courses seemed to be safe
.
No level 3 IRR was observed in C2, and only one case of level 3 IRR was reported in the subsequent cycle
.
No new safety signals have been reported for short-term infusion of otuzumab, and the therapeutic response to the end of induction therapy is consistent with previous studies
.
Short-term infusion of otuzumab may improve patient convenience and infusion efficiency
.
GALLIUM study 5, the key study in which otuzumab was approved, confirmed the safety of the otuzumab treatment group for FL patients
.
The GAZELLE study confirmed the safety and convenience of a 90-minute short-term infusion (SDI) of Otuzumab for FL patients starting from C2
.
Although Otuzumab has been on the market in the United States for 8 years, it has just been marketed in China, and experts have little experience in clinical medication
.
It is believed that based on the rich experience in the application of rituximab accumulated over the past 20 years, the continuous increase in the use of otuzumab, and the continuous improvement of the safety management level of otuzumab, Chinese experts will consider otuzumab It is better applied to patients with follicular lymphoma to achieve the goal of good medicinal use
.
References 1.
Instructions for otuzumab injection 2.
NCCN Guidelines for B-cell Lymphoma, 2021 first edition 3.
2021 ASCO conference abstract number: 75454.
2021 EHA conference abstract number: EP8075.
Marcus R, et al .
N EngJ Med 2017;377:1331‒44 stamp "Read the original", we make progress together
