-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
The 2021 American Society of Clinical Oncology (ASCO) annual meeting will be held in the near future.
Two studies announced at the meeting will explore the selection of induction options for initial treatment of mantle cell lymphoma (MCL).
The editor now organizes the main contents of the two studies as follows for the reference of readers.
Abstract 7503: The BR regimen combined with bortezomib did not improve the PFS of newly treated MCL patients.
The best treatment regimen for MCL is still inconclusive.
Phase II E1411 study of bendamustine combined with rituximab (BR regimen) It is explored whether the induction therapy program combined with bortezomib (BVR program) can improve the progression-free survival (PFS) of MCL patients on the basis of the research.
The study also explored the combination of rituximab (R) on the basis of a single drug Can the consolidation treatment of lenalidomide (LR regimen) improve PFS in patients with MCL?
The results of the comparison of the efficacy and safety of the BVR regimen and the BR regimen in the induction treatment phase of the study are now announced.
Research methods The study included 373 newly-treated MCL patients aged ≥18 years and ECOG score 0-2 from 2012 to 2016.
The patients were divided into 4 groups according to MIPI score and age to receive: A) BR regimen induction therapy , R single-agent consolidation therapy; B) BVR regimen induction therapy, R single-agent consolidation therapy; C) BR regimen induction therapy, LR regimen consolidation therapy; D) BVR regimen induction therapy, LR regimen consolidation therapy.
The main purpose of the induction treatment phase of the study is to explore whether the BVR induction treatment regimen (B+D group) can improve the PFS of patients compared with the BR induction treatment regimen (A+C group).
Research Results In the study, 179 patients received induction therapy with BVR regimen, of which 144 patients completed induction therapy, 6 patients experienced disease progression, and 140 patients received follow-up consolidation therapy; 180 patients received induction therapy with BR regimen, of which 153 patients completed induction therapy, 7 patients experienced disease progression, and 145 patients received follow-up consolidation therapy.
The baseline characteristics of the two groups of patients were similar.
The median patient age was 67 years (range: 42-90 years), 13% of the patients were younger than 60 years old, 73% of the patients were male, and 97% of the patients had an ECOG score of 0-1.
, MIPI scores of low-risk, intermediate-risk, and high-risk patients accounted for 37%, 29%, and 34%, respectively.
In the study, the estimated 2-year PFS rate of patients in the BVR group was 79.
6% (95%CI: 73.
8%-85.
9%), and the estimated 2-year PFS rate of patients in the BR group was 74.
5% (95%CI: 68.
2%-81.
4%) ; Unilateral P=0.
268).
At a median follow-up of 51 months, the estimated median PFS of the two groups were 64.
1 months and 64.
0 months, respectively.
The overall response rate (ORR) of patients in the BVR group was 88.
9%, and the complete response (CR) rate was 65.
5%; the ORR of the BR group was 89.
5%, and the CR rate was 60.
5% (ORR: unilateral P=0.
577) 2 in the BVR group There were 2 treatment-related deaths (causes of death were cardiac arrest and hepatitis), and 1 case occurred in the BR group (causes of death were tumor lysis).
The incidence of adverse events of grade ≥3 in the two groups was 88.
1% and 77.
5%, respectively.
52 patients in the BVR group and 39 patients in the BR group developed grade ≥3 neutropenia, but grade ≥3 neutropenia in the two groups The occurrence of sexual fever (7 cases vs.
6 cases), anemia (7 cases vs.
8 cases), and thrombocytopenia (18 cases vs.
16 cases) were similar.
There were 8 cases of grade 2 peripheral neuropathy (PN) in the BVR group (all sensory symptoms), 3 cases of PN (2 cases of sensory symptoms, 1 case of motor symptoms) in the BR group; 7 cases of grade 3 PN (6 cases in the BVR group) 1 case of sensory symptoms, 1 case of motor symptoms), no grade 3 PN occurred in the BR group.
The only non-hematological toxicity event with an incidence ≥5% in the study was skin rash, with 9 cases and 12 cases in the two groups respectively.
The study concluded that the BVR regimen did not significantly improve the PFS of MCL patients compared with the BR regimen, and the ORR and CR rates obtained by the two induction regimens were also similar.
Based on the previous results announced at the 2019 ASH conference (PFS> 5 years, high ORR, high minimal residual disease [MRD] negative rate), the study still supports BR-based treatment as an induction treatment for newly-treated MCL patients .
The study will continue to compare the efficacy and safety of R monotherapy and RL regimen as a consolidation therapy in MCL patients.
Abstract 7505: LR regimen combined with Veneclax in the treatment of initial treatment of MCL is safe and effective.
Related research suggests that the combination of LR regimen with Vineckel (V) is a safe and effective treatment option for MCL patients.
At the same time, the clinical benefits brought by the program are The benefit has nothing to do with the patient’s age, disease form or stage.
A multicenter phase Ib study (NCT03523975) explored the efficacy and safety of this combination regimen in newly treated MCL patients.
Research method The study included patients with newly-treated MCL aged ≥18 years who received lenalidomide for 12 months (days 1-21 of each treatment cycle, 20 mg per day), rituximab (the first 1 treatment cycle once a week, followed by the 1st day of each even-numbered treatment cycle), Venecla (dose increase from the 8th day, and reach 400mg per day within 4 weeks) induction therapy.
The purpose of the study is to determine the safety and tolerability of the combined regimen, and to determine the maximum tolerated dose (MTD) of the regimen.
The dose-limiting toxicity period (DLT) started on the 8th day of the first treatment cycle and lasted for 42 days.
Patients in the study will then continue to receive lenalidomide (10 mg or half of the last dose used during the induction period for 24 months), rituximab (administered once every 8 weeks for 36 months), vinac Carat (administered for at least 12 months) maintenance treatment.
No patients in the study received a transplant, and patients with disease progression will be removed from the study.
Patients in the study will use clonoSEQ to detect MRD status during the induction treatment phase.
The results of the study are as of February 1, 2021.
The study enrolled 28 patients as planned, with a median treatment time of 278 days (IQR: 170-560), of which 24 patients are still receiving treatment. The dose of venacola was increased to 400 mg in all patients, and there were no dose-limiting toxicity events.
The incidence of treatment-related adverse events (TEAE) in the study was 100%, and 26 patients (93%) had grade 3 TEAEs or more.
The most common (incidence ≥50%) TEAEs are fatigue, neutropenia, and diarrhea.
Grade ≥3 TEAEs with an incidence ≥50% include neutropenia (68%) and thrombocytopenia (50%).
%).
No patient withdrew from the study because of TEAE, and a grade 5 pulmonary embolism (PE) occurred in a patient whose efficacy could not be assessed during DLT.
The ORR of the 28 patients in the study was 96%, and the CR/uncertain complete response (CRu) rate was 89%.
Among the patients who achieved disease remission, one patient who achieved CR and one patient who achieved PR subsequently developed disease progression, and all patients with disease progression had a TP53 mutation at baseline.
The overall MRD status of the patients was good, and 20 patients (71%) got MRD negative at the level of 10-6.
Research conclusions The research results show that the daily 400mg dose of venacral combined with lenalidomide and rituximab can bring a higher negative rate of ORR and MRD for MCL patients, while the safety is controllable.
The safety data of the joint program in the study is consistent with previous studies, and there are no new safety signals.
Reference source: 1.
Mitchell Reed Smith, et al.
ECOG-ACRIN E1411 randomized phase 2 trial of bendamustine-rituximab (BR)-based induction followed by rituximab (R) ±lenalidomide (L) consolidation for Mantle cell lymphoma: Effect of addingbortezomib to frontline BR induction on PFS.
2021 ASCO Annual Meeting.
Abstract7503.
2.
TycelPhillips, et al.
The combination of venetoclax, lenalidomide, and rituximab inpatients with newly diagnosed mantle cell lymphoma induces high response rates and MRD undetectability.
2021 ASCO Annual Meeting.
Abstract 7505.
Poke "read the original text", we make progress together
Two studies announced at the meeting will explore the selection of induction options for initial treatment of mantle cell lymphoma (MCL).
The editor now organizes the main contents of the two studies as follows for the reference of readers.
Abstract 7503: The BR regimen combined with bortezomib did not improve the PFS of newly treated MCL patients.
The best treatment regimen for MCL is still inconclusive.
Phase II E1411 study of bendamustine combined with rituximab (BR regimen) It is explored whether the induction therapy program combined with bortezomib (BVR program) can improve the progression-free survival (PFS) of MCL patients on the basis of the research.
The study also explored the combination of rituximab (R) on the basis of a single drug Can the consolidation treatment of lenalidomide (LR regimen) improve PFS in patients with MCL?
The results of the comparison of the efficacy and safety of the BVR regimen and the BR regimen in the induction treatment phase of the study are now announced.
Research methods The study included 373 newly-treated MCL patients aged ≥18 years and ECOG score 0-2 from 2012 to 2016.
The patients were divided into 4 groups according to MIPI score and age to receive: A) BR regimen induction therapy , R single-agent consolidation therapy; B) BVR regimen induction therapy, R single-agent consolidation therapy; C) BR regimen induction therapy, LR regimen consolidation therapy; D) BVR regimen induction therapy, LR regimen consolidation therapy.
The main purpose of the induction treatment phase of the study is to explore whether the BVR induction treatment regimen (B+D group) can improve the PFS of patients compared with the BR induction treatment regimen (A+C group).
Research Results In the study, 179 patients received induction therapy with BVR regimen, of which 144 patients completed induction therapy, 6 patients experienced disease progression, and 140 patients received follow-up consolidation therapy; 180 patients received induction therapy with BR regimen, of which 153 patients completed induction therapy, 7 patients experienced disease progression, and 145 patients received follow-up consolidation therapy.
The baseline characteristics of the two groups of patients were similar.
The median patient age was 67 years (range: 42-90 years), 13% of the patients were younger than 60 years old, 73% of the patients were male, and 97% of the patients had an ECOG score of 0-1.
, MIPI scores of low-risk, intermediate-risk, and high-risk patients accounted for 37%, 29%, and 34%, respectively.
In the study, the estimated 2-year PFS rate of patients in the BVR group was 79.
6% (95%CI: 73.
8%-85.
9%), and the estimated 2-year PFS rate of patients in the BR group was 74.
5% (95%CI: 68.
2%-81.
4%) ; Unilateral P=0.
268).
At a median follow-up of 51 months, the estimated median PFS of the two groups were 64.
1 months and 64.
0 months, respectively.
The overall response rate (ORR) of patients in the BVR group was 88.
9%, and the complete response (CR) rate was 65.
5%; the ORR of the BR group was 89.
5%, and the CR rate was 60.
5% (ORR: unilateral P=0.
577) 2 in the BVR group There were 2 treatment-related deaths (causes of death were cardiac arrest and hepatitis), and 1 case occurred in the BR group (causes of death were tumor lysis).
The incidence of adverse events of grade ≥3 in the two groups was 88.
1% and 77.
5%, respectively.
52 patients in the BVR group and 39 patients in the BR group developed grade ≥3 neutropenia, but grade ≥3 neutropenia in the two groups The occurrence of sexual fever (7 cases vs.
6 cases), anemia (7 cases vs.
8 cases), and thrombocytopenia (18 cases vs.
16 cases) were similar.
There were 8 cases of grade 2 peripheral neuropathy (PN) in the BVR group (all sensory symptoms), 3 cases of PN (2 cases of sensory symptoms, 1 case of motor symptoms) in the BR group; 7 cases of grade 3 PN (6 cases in the BVR group) 1 case of sensory symptoms, 1 case of motor symptoms), no grade 3 PN occurred in the BR group.
The only non-hematological toxicity event with an incidence ≥5% in the study was skin rash, with 9 cases and 12 cases in the two groups respectively.
The study concluded that the BVR regimen did not significantly improve the PFS of MCL patients compared with the BR regimen, and the ORR and CR rates obtained by the two induction regimens were also similar.
Based on the previous results announced at the 2019 ASH conference (PFS> 5 years, high ORR, high minimal residual disease [MRD] negative rate), the study still supports BR-based treatment as an induction treatment for newly-treated MCL patients .
The study will continue to compare the efficacy and safety of R monotherapy and RL regimen as a consolidation therapy in MCL patients.
Abstract 7505: LR regimen combined with Veneclax in the treatment of initial treatment of MCL is safe and effective.
Related research suggests that the combination of LR regimen with Vineckel (V) is a safe and effective treatment option for MCL patients.
At the same time, the clinical benefits brought by the program are The benefit has nothing to do with the patient’s age, disease form or stage.
A multicenter phase Ib study (NCT03523975) explored the efficacy and safety of this combination regimen in newly treated MCL patients.
Research method The study included patients with newly-treated MCL aged ≥18 years who received lenalidomide for 12 months (days 1-21 of each treatment cycle, 20 mg per day), rituximab (the first 1 treatment cycle once a week, followed by the 1st day of each even-numbered treatment cycle), Venecla (dose increase from the 8th day, and reach 400mg per day within 4 weeks) induction therapy.
The purpose of the study is to determine the safety and tolerability of the combined regimen, and to determine the maximum tolerated dose (MTD) of the regimen.
The dose-limiting toxicity period (DLT) started on the 8th day of the first treatment cycle and lasted for 42 days.
Patients in the study will then continue to receive lenalidomide (10 mg or half of the last dose used during the induction period for 24 months), rituximab (administered once every 8 weeks for 36 months), vinac Carat (administered for at least 12 months) maintenance treatment.
No patients in the study received a transplant, and patients with disease progression will be removed from the study.
Patients in the study will use clonoSEQ to detect MRD status during the induction treatment phase.
The results of the study are as of February 1, 2021.
The study enrolled 28 patients as planned, with a median treatment time of 278 days (IQR: 170-560), of which 24 patients are still receiving treatment. The dose of venacola was increased to 400 mg in all patients, and there were no dose-limiting toxicity events.
The incidence of treatment-related adverse events (TEAE) in the study was 100%, and 26 patients (93%) had grade 3 TEAEs or more.
The most common (incidence ≥50%) TEAEs are fatigue, neutropenia, and diarrhea.
Grade ≥3 TEAEs with an incidence ≥50% include neutropenia (68%) and thrombocytopenia (50%).
%).
No patient withdrew from the study because of TEAE, and a grade 5 pulmonary embolism (PE) occurred in a patient whose efficacy could not be assessed during DLT.
The ORR of the 28 patients in the study was 96%, and the CR/uncertain complete response (CRu) rate was 89%.
Among the patients who achieved disease remission, one patient who achieved CR and one patient who achieved PR subsequently developed disease progression, and all patients with disease progression had a TP53 mutation at baseline.
The overall MRD status of the patients was good, and 20 patients (71%) got MRD negative at the level of 10-6.
Research conclusions The research results show that the daily 400mg dose of venacral combined with lenalidomide and rituximab can bring a higher negative rate of ORR and MRD for MCL patients, while the safety is controllable.
The safety data of the joint program in the study is consistent with previous studies, and there are no new safety signals.
Reference source: 1.
Mitchell Reed Smith, et al.
ECOG-ACRIN E1411 randomized phase 2 trial of bendamustine-rituximab (BR)-based induction followed by rituximab (R) ±lenalidomide (L) consolidation for Mantle cell lymphoma: Effect of addingbortezomib to frontline BR induction on PFS.
2021 ASCO Annual Meeting.
Abstract7503.
2.
TycelPhillips, et al.
The combination of venetoclax, lenalidomide, and rituximab inpatients with newly diagnosed mantle cell lymphoma induces high response rates and MRD undetectability.
2021 ASCO Annual Meeting.
Abstract 7505.
Poke "read the original text", we make progress together
