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Recent popular reports by Yimike ★ The article elaborates: CAR-T production whole-process solution combing ★ Focusing on CAR-T cell transformation, where is the next generation of CAR-T therapy? Medicine New Observation May 20, 2021/eMedClub News/---The annual global oncology event---The American Society of Clinical Oncology (ASCO 2021) will be held soon.
Janssen and Legend announced relevant abstracts on BCMA CAR-T product cilta-cel (Ciltacabtagene autoleucel; JNJ-68284528; LCAR-B38M) at the ASCO 2021 meeting.
The clinical data is very positive.
Recommended reading: The last CAR-T listing application form at the end of 2020? Legendary Bio-BCMA CAR-T completes the fifth milestoneYimai Meng reveals that the accelerated review request of Legendary Bio-BCMA CAR-T in the EU has been approved.
It is expected to be submitted in the first half of the yearYimai Meng broke the news that CARTITUDE-2 CARTITUDE-2 is one This multi-cohort Phase 2 clinical study (NCT04133636) aims to evaluate the safety and effectiveness of cilta-cel infusion in various clinical settings for patients with multiple myeloma (MM), and to explore the applicability of outpatient medication.
Cohort A: MM patients have previously received 1-3 treatment lines (including proteasome inhibitors, immunomodulatory drugs, lenalidomide refractory, and have not previously received BCMA targeted therapy) and then the disease progresses.
The patient was pretreated with cyclophosphamide and fludarabine, and then infused with cilta-cel (target dose: 0.
75×106 CAR+ viable T cells/kg).As of February 2021, 20 patients received cilta-cel infusion; 1 patient received treatment in the outpatient clinic, the median treatment for all patients was 2nd-line (1-3), and 12 patients were less than 3rd-line treatment , 8 patients had previously received 3 treatments.
The results showed that the overall response rate was 95% (95% CI: 75-100), the strict complete response (CR)/CR was 75% (95% CI: 51-91), and 85% (95% CI: 62- 97) Reach ≥VGPR.
The median time to first remission was 1mo (0.
7-3.
3), the median time to obtain the best remission was 1.
9mo (0.
9-5.
1), and the median duration of response was not reached.
Among the 4 patients evaluable by MRD, all patients were MRD negative at the cutoff of 10-5 data.
Safety: Common hematological AEs include neutropenia, thrombocytopenia, anemia, lymphopenia, and leukopenia.
CRS occurred in 85% of patients, 10% was grade 3/4, the median duration of CRS was 7 days (5-9), and the median duration was 3.
5 days (2-11); 20% of patients developed CAR -T cell neurotoxicity, all grades are 1/2.
3 patients developed ICANS (1 case of grade 1, 2 cases of grade 2), the median onset time was 8 days (7-11), and the median duration of the disease was 2 days (1-2); 1 patient developed grade 2 facial paralysis, The occurrence time was 29 days and the duration was 51 days; 1 patient died of COVID-19.
In addition, the infusion of cilta-cel in the outpatient (non-inpatient) clinic is safe and controllable.
All in all, at the recommended phase 2 dose, a single cilta-cel infusion can lead to an early and stronger response.
For MM patients with a history of LOT of 1-3, its safety is controllable.
CARTITUDE-1 CARTITUDE-1 is a phase 1b/2 study designed to evaluate the safety and effectiveness of cilta-cel in the treatment of MM patients.
The abstract published in ASCO 2021 shows the updated results with a median follow-up time of 12.
4 months. As of September 1, 2020, 97 patients with a median treatment line of 6 received cilta-cel treatment, and the overall response rate of the primary endpoint reached 97% (95% CI, 91-99), of which 67% achieved sCR .
The median time to first remission was 1 month (1-9), and the median time to CR/sCR was 2 months (1-15).
Over time, remission continued to deepen, and the median duration of response was not reached .
Of the 57 patients evaluable by MRD, 93% were MRD negative at 10-5.
The 12-month progression-free survival (PFS) and overall survival rates were 77% and 89%, respectively, and the median PFS was not reached.
The incidence of grade 3/4 hematology adverse events (AEs) ≥20%, including neutropenia (95%), anemia (68%), leukopenia (61%), thrombocytopenia (60%) ) And lymphopenia (50%).
95% of patients experienced CRS, of which 4% were grade 3/4, the median onset time was 7 days (1-12), and the median duration was 4 days (1-14, excluding 1 patient.
The duration of CRS was 97-day), CRS was resolved in all patients except Grade 5 CRS/phagocytic lymphohistiocytosis.
21% of patients experienced CAR-T cell neurotoxicity, 10% ≥ grade 3.
In the study, 14 deaths occurred after cilta-cel infusion.
There were no deaths in the first 30 days, 2 deaths within 100 days, and 12 deaths after 100 days.
Among them, 5 deaths were due to disease progression and 4 were due to treatment-related deaths.
AE.
In 12 cases, more than 100 days after infusion, 5 cases were due to disease progression and 4 cases were due to treatment-related AEs.
Reference materials: 1.
https://meetinglibrary.
asco.
org/record/195446/abstract2.
https://meetinglibrary.
asco.
org/record/195437/abstractMeetinglibrary has always been committed to cutting-edge technology and industry trends in bio-innovative drugs , Industry Insights and other original news reports, all media high-end matrix users reached 160,000+, of which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
Janssen and Legend announced relevant abstracts on BCMA CAR-T product cilta-cel (Ciltacabtagene autoleucel; JNJ-68284528; LCAR-B38M) at the ASCO 2021 meeting.
The clinical data is very positive.
Recommended reading: The last CAR-T listing application form at the end of 2020? Legendary Bio-BCMA CAR-T completes the fifth milestoneYimai Meng reveals that the accelerated review request of Legendary Bio-BCMA CAR-T in the EU has been approved.
It is expected to be submitted in the first half of the yearYimai Meng broke the news that CARTITUDE-2 CARTITUDE-2 is one This multi-cohort Phase 2 clinical study (NCT04133636) aims to evaluate the safety and effectiveness of cilta-cel infusion in various clinical settings for patients with multiple myeloma (MM), and to explore the applicability of outpatient medication.
Cohort A: MM patients have previously received 1-3 treatment lines (including proteasome inhibitors, immunomodulatory drugs, lenalidomide refractory, and have not previously received BCMA targeted therapy) and then the disease progresses.
The patient was pretreated with cyclophosphamide and fludarabine, and then infused with cilta-cel (target dose: 0.
75×106 CAR+ viable T cells/kg).As of February 2021, 20 patients received cilta-cel infusion; 1 patient received treatment in the outpatient clinic, the median treatment for all patients was 2nd-line (1-3), and 12 patients were less than 3rd-line treatment , 8 patients had previously received 3 treatments.
The results showed that the overall response rate was 95% (95% CI: 75-100), the strict complete response (CR)/CR was 75% (95% CI: 51-91), and 85% (95% CI: 62- 97) Reach ≥VGPR.
The median time to first remission was 1mo (0.
7-3.
3), the median time to obtain the best remission was 1.
9mo (0.
9-5.
1), and the median duration of response was not reached.
Among the 4 patients evaluable by MRD, all patients were MRD negative at the cutoff of 10-5 data.
Safety: Common hematological AEs include neutropenia, thrombocytopenia, anemia, lymphopenia, and leukopenia.
CRS occurred in 85% of patients, 10% was grade 3/4, the median duration of CRS was 7 days (5-9), and the median duration was 3.
5 days (2-11); 20% of patients developed CAR -T cell neurotoxicity, all grades are 1/2.
3 patients developed ICANS (1 case of grade 1, 2 cases of grade 2), the median onset time was 8 days (7-11), and the median duration of the disease was 2 days (1-2); 1 patient developed grade 2 facial paralysis, The occurrence time was 29 days and the duration was 51 days; 1 patient died of COVID-19.
In addition, the infusion of cilta-cel in the outpatient (non-inpatient) clinic is safe and controllable.
All in all, at the recommended phase 2 dose, a single cilta-cel infusion can lead to an early and stronger response.
For MM patients with a history of LOT of 1-3, its safety is controllable.
CARTITUDE-1 CARTITUDE-1 is a phase 1b/2 study designed to evaluate the safety and effectiveness of cilta-cel in the treatment of MM patients.
The abstract published in ASCO 2021 shows the updated results with a median follow-up time of 12.
4 months. As of September 1, 2020, 97 patients with a median treatment line of 6 received cilta-cel treatment, and the overall response rate of the primary endpoint reached 97% (95% CI, 91-99), of which 67% achieved sCR .
The median time to first remission was 1 month (1-9), and the median time to CR/sCR was 2 months (1-15).
Over time, remission continued to deepen, and the median duration of response was not reached .
Of the 57 patients evaluable by MRD, 93% were MRD negative at 10-5.
The 12-month progression-free survival (PFS) and overall survival rates were 77% and 89%, respectively, and the median PFS was not reached.
The incidence of grade 3/4 hematology adverse events (AEs) ≥20%, including neutropenia (95%), anemia (68%), leukopenia (61%), thrombocytopenia (60%) ) And lymphopenia (50%).
95% of patients experienced CRS, of which 4% were grade 3/4, the median onset time was 7 days (1-12), and the median duration was 4 days (1-14, excluding 1 patient.
The duration of CRS was 97-day), CRS was resolved in all patients except Grade 5 CRS/phagocytic lymphohistiocytosis.
21% of patients experienced CAR-T cell neurotoxicity, 10% ≥ grade 3.
In the study, 14 deaths occurred after cilta-cel infusion.
There were no deaths in the first 30 days, 2 deaths within 100 days, and 12 deaths after 100 days.
Among them, 5 deaths were due to disease progression and 4 were due to treatment-related deaths.
AE.
In 12 cases, more than 100 days after infusion, 5 cases were due to disease progression and 4 cases were due to treatment-related AEs.
Reference materials: 1.
https://meetinglibrary.
asco.
org/record/195446/abstract2.
https://meetinglibrary.
asco.
org/record/195437/abstractMeetinglibrary has always been committed to cutting-edge technology and industry trends in bio-innovative drugs , Industry Insights and other original news reports, all media high-end matrix users reached 160,000+, of which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
