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*Only for medical professionals to read and reference for 1 minute a day, to give you professional "talks" in the tumor circle! (If you want the original text of the document, you can add the editor WeChat yxj_oncology to get it.
) Key points NEJM: CD19 CAR-T second-line treatment of large B-cell lymphoma has a considerable effect NEJM: Another CD19 CAR-T treatment of aggressive B-cell lymphoma is blocked, or not Better than Standard Treatment Drugs News: The seventh batch of national procurement information reporting involves a variety of new anti-tumor drugs: Olaparib plus abiraterone combined treatment for prostate cancer has made positive progress New drug: Another KRAS G12C inhibitor new drug application was accepted by the FDA01NEJM : CD19 CAR-T in the second-line treatment of large B-cell lymphoma has a promising effect.
Patients with early-stage relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who have received first-line chemoimmunotherapy have poor prognosis
.
Recently, a study investigating Axicabtagene Ciloleucel (axi-cel, an autologous anti-CD19 CAR-T therapy) as a second-line treatment for LBCL was published in NEJM
.
The results showed a significant improvement in event-free survival (EFS) and disease remission with Axi-cel compared to standard therapy, and high-grade toxicity occurred as expected
.
In this international phase III trial, patients with relapsed or refractory LBCL within 12 months of first-line chemoimmunotherapy were randomly assigned (1:1) to receive axi-cel or standard therapy (using investigator's choice of , two or three cycles of chemoimmunotherapy, and high-dose chemotherapy and autologous stem cell transplantation for responding patients)
.
The primary endpoint was EFS by blinded central evaluation
.
Key secondary endpoints included response rate and overall survival (OS), and investigators also assessed safety
.
A total of 180 patients received axi-cel (axi-cel group) and 179 patients received standard of care (standard-of-care group)
.
Analysis of the primary endpoint, EFS, showed that axi-cel treatment was superior to standard care
.
At a median follow-up of 24.
9 months, the median EFS was 8.
3 months in the axi-cel group and 2.
0 months in the standard care group, with 24-month EFS rates of 41% and 16%, respectively (HR 0.
40 for progression or death; 95 %CI, 0.
31-0.
51; P<0.
001)
.
The response rate was 83% in the Axi-cel arm and 50% in the standard-therapy arm (complete responses in 65% and 32% of patients, respectively)
.
At the interim analysis, the estimated two-year OS rate was 61% in the axi-cel arm and 52% in the standard care arm
.
Adverse events of grade 3 or higher occurred in 91% of the axi-cel arm and 83% of the standard-of-care arm
.
Grade 3 or higher cytokine release syndrome (CRS) occurred in 6% of patients receiving axi-cel, and grade 3 or higher neurological events occurred in 21%
.
No deaths related to CRS or neurological events occurred
.
02NEJM: Another CD19 CAR-T for aggressive B-cell lymphoma blocked or not better than standard therapy in patients with aggressive B-cell non-Hodgkin lymphoma who have not responded or progressed within 12 months after first-line therapy with poor prognosis
.
Tisagenlecleucel is an anti-CD19 CAR-T therapy approved for diffuse large B-cell lymphoma (DLBCL) that has received at least second-line therapy
.
A study comparing second-line Tisagenlecleucel therapy with standard therapy for aggressive B-cell lymphoma was published in NEJM
.
Studies have shown that Tisagenlecleucel is not superior to standard salvage therapy
.
The researchers note that further research is still needed to assess which patients are likely to benefit most from each approach
.
Official website screenshot This international phase III trial enrolled patients with aggressive lymphoma who were refractory or progressed within 12 months of first-line therapy
.
Patients were randomly assigned to Tisagenlecucel + selective bridging therapy (Tisagenlecucel group) or salvage chemotherapy + autologous hematopoietic stem cell transplantation (HSCT) (standard care group)
.
The primary endpoint was EFS, defined as the time from randomization to stable or progressive disease at or after the Week 12 assessment or death
.
Crossover to Tisagenlecucel was permitted if a definite event occurred at or after the Week 12 assessment
.
Other endpoints included treatment response and safety
.
A total of 322 patients were enrolled in this trial
.
At baseline, the Tisagenlecleucel group had a higher percentage of patients with high-grade lymphoma than the standard-care group (24.
1% vs 16.
9%) with an International Prognostic Index score (range 0-5, with higher scores indicating poorer prognosis) of 2 or higher ( 65.
4% vs.
57.
5%) percentage of patients
.
A total of 95.
7% of patients in the Tisagenlecleucel group received Tisagenlecleucel; 32.
5% of patients in the standard care group received autologous HSCT
.
The median time from leukapheresis to Tisagenlecleucel infusion was 52 days
.
25.
9% of patients in the Tisagenlecleucel group had lymphoma progression at week 6, compared with 13.
8% in the standard-therapy group
.
Median EFS was 3.
0 months in both groups (HR 1.
07 for progression or death; 95% CI, 0.
82-1.
40; P=0.
61)
.
Responses occurred in 46.
3% and 42.
5% of patients in the Tisagenlecleucel and standard care groups, respectively, and 10 and 13 patients, respectively, died from adverse events
.
03 Drug News: The seventh batch of national procurement information reporting involves a variety of anti-tumor drugs.
According to the "Notice on Carrying out the Seventh Batch of Nationally Organized Centralized Drug Procurement Related Drug Information Reporting Work" issued by the Shanghai Sunshine Drug Procurement Platform on February 17, The filing of the listed drug information will begin on February 18, involving a total of 58 varieties and 208 specifications, including a variety of anti-tumor drugs, including afatinib, erlotinib, lenvatinib and su Nitinib,
etc.
04New drug: Olaparib combined with abiraterone has made positive progress in the treatment of prostate cancer Recently, olaparib combined with abiraterone has shown considerable effect in the Phase III trial PROpel in the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC).
.
The combination reduced the risk of disease progression by 34% compared to abiraterone alone
.
Olapari was approved for the first time in China in August 2018, and has been approved for multiple indications in the fields of ovarian cancer and prostate cancer
.
05 New Drug: Another KRAS G12C Inhibitor New Drug Application Accepted by FDA On February 16, the U.
S.
Food and Drug Administration (FDA) accepted the new drug application for KRAS G12C inhibitor Adagrasib submitted by Mirati Therapeutics, with the indication for carrying KRAS G12C Mutated non-small cell lung cancer (NSCLC)
.
The review process will use the accelerated approval pathway and will use the FDA's Real Time Oncology Review (RTOR) pilot program
.
Adagrasib was granted Breakthrough Therapy Designation by the U.
S.
FDA in June last year
.
References: 1.
Frederick LL, et al.
Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.
N Engl J Med 2022; 386:640-654.
DOI: 10.
1056/NEJMoa2116133 https:// /doi/full/10.
1056/NEJMoa21161332.
Bishop MR, et al.
Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.
N Engl J Med 2022; 386:629-639.
DOI: 10.
1056/NEJMoa2116596 https:// https://mp.
weixin.
qq.
com/s/lCPFpeUZd5fIOCaLo9ZOSQ
) Key points NEJM: CD19 CAR-T second-line treatment of large B-cell lymphoma has a considerable effect NEJM: Another CD19 CAR-T treatment of aggressive B-cell lymphoma is blocked, or not Better than Standard Treatment Drugs News: The seventh batch of national procurement information reporting involves a variety of new anti-tumor drugs: Olaparib plus abiraterone combined treatment for prostate cancer has made positive progress New drug: Another KRAS G12C inhibitor new drug application was accepted by the FDA01NEJM : CD19 CAR-T in the second-line treatment of large B-cell lymphoma has a promising effect.
Patients with early-stage relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who have received first-line chemoimmunotherapy have poor prognosis
.
Recently, a study investigating Axicabtagene Ciloleucel (axi-cel, an autologous anti-CD19 CAR-T therapy) as a second-line treatment for LBCL was published in NEJM
.
The results showed a significant improvement in event-free survival (EFS) and disease remission with Axi-cel compared to standard therapy, and high-grade toxicity occurred as expected
.
In this international phase III trial, patients with relapsed or refractory LBCL within 12 months of first-line chemoimmunotherapy were randomly assigned (1:1) to receive axi-cel or standard therapy (using investigator's choice of , two or three cycles of chemoimmunotherapy, and high-dose chemotherapy and autologous stem cell transplantation for responding patients)
.
The primary endpoint was EFS by blinded central evaluation
.
Key secondary endpoints included response rate and overall survival (OS), and investigators also assessed safety
.
A total of 180 patients received axi-cel (axi-cel group) and 179 patients received standard of care (standard-of-care group)
.
Analysis of the primary endpoint, EFS, showed that axi-cel treatment was superior to standard care
.
At a median follow-up of 24.
9 months, the median EFS was 8.
3 months in the axi-cel group and 2.
0 months in the standard care group, with 24-month EFS rates of 41% and 16%, respectively (HR 0.
40 for progression or death; 95 %CI, 0.
31-0.
51; P<0.
001)
.
The response rate was 83% in the Axi-cel arm and 50% in the standard-therapy arm (complete responses in 65% and 32% of patients, respectively)
.
At the interim analysis, the estimated two-year OS rate was 61% in the axi-cel arm and 52% in the standard care arm
.
Adverse events of grade 3 or higher occurred in 91% of the axi-cel arm and 83% of the standard-of-care arm
.
Grade 3 or higher cytokine release syndrome (CRS) occurred in 6% of patients receiving axi-cel, and grade 3 or higher neurological events occurred in 21%
.
No deaths related to CRS or neurological events occurred
.
02NEJM: Another CD19 CAR-T for aggressive B-cell lymphoma blocked or not better than standard therapy in patients with aggressive B-cell non-Hodgkin lymphoma who have not responded or progressed within 12 months after first-line therapy with poor prognosis
.
Tisagenlecleucel is an anti-CD19 CAR-T therapy approved for diffuse large B-cell lymphoma (DLBCL) that has received at least second-line therapy
.
A study comparing second-line Tisagenlecleucel therapy with standard therapy for aggressive B-cell lymphoma was published in NEJM
.
Studies have shown that Tisagenlecleucel is not superior to standard salvage therapy
.
The researchers note that further research is still needed to assess which patients are likely to benefit most from each approach
.
Official website screenshot This international phase III trial enrolled patients with aggressive lymphoma who were refractory or progressed within 12 months of first-line therapy
.
Patients were randomly assigned to Tisagenlecucel + selective bridging therapy (Tisagenlecucel group) or salvage chemotherapy + autologous hematopoietic stem cell transplantation (HSCT) (standard care group)
.
The primary endpoint was EFS, defined as the time from randomization to stable or progressive disease at or after the Week 12 assessment or death
.
Crossover to Tisagenlecucel was permitted if a definite event occurred at or after the Week 12 assessment
.
Other endpoints included treatment response and safety
.
A total of 322 patients were enrolled in this trial
.
At baseline, the Tisagenlecleucel group had a higher percentage of patients with high-grade lymphoma than the standard-care group (24.
1% vs 16.
9%) with an International Prognostic Index score (range 0-5, with higher scores indicating poorer prognosis) of 2 or higher ( 65.
4% vs.
57.
5%) percentage of patients
.
A total of 95.
7% of patients in the Tisagenlecleucel group received Tisagenlecleucel; 32.
5% of patients in the standard care group received autologous HSCT
.
The median time from leukapheresis to Tisagenlecleucel infusion was 52 days
.
25.
9% of patients in the Tisagenlecleucel group had lymphoma progression at week 6, compared with 13.
8% in the standard-therapy group
.
Median EFS was 3.
0 months in both groups (HR 1.
07 for progression or death; 95% CI, 0.
82-1.
40; P=0.
61)
.
Responses occurred in 46.
3% and 42.
5% of patients in the Tisagenlecleucel and standard care groups, respectively, and 10 and 13 patients, respectively, died from adverse events
.
03 Drug News: The seventh batch of national procurement information reporting involves a variety of anti-tumor drugs.
According to the "Notice on Carrying out the Seventh Batch of Nationally Organized Centralized Drug Procurement Related Drug Information Reporting Work" issued by the Shanghai Sunshine Drug Procurement Platform on February 17, The filing of the listed drug information will begin on February 18, involving a total of 58 varieties and 208 specifications, including a variety of anti-tumor drugs, including afatinib, erlotinib, lenvatinib and su Nitinib,
etc.
04New drug: Olaparib combined with abiraterone has made positive progress in the treatment of prostate cancer Recently, olaparib combined with abiraterone has shown considerable effect in the Phase III trial PROpel in the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC).
.
The combination reduced the risk of disease progression by 34% compared to abiraterone alone
.
Olapari was approved for the first time in China in August 2018, and has been approved for multiple indications in the fields of ovarian cancer and prostate cancer
.
05 New Drug: Another KRAS G12C Inhibitor New Drug Application Accepted by FDA On February 16, the U.
S.
Food and Drug Administration (FDA) accepted the new drug application for KRAS G12C inhibitor Adagrasib submitted by Mirati Therapeutics, with the indication for carrying KRAS G12C Mutated non-small cell lung cancer (NSCLC)
.
The review process will use the accelerated approval pathway and will use the FDA's Real Time Oncology Review (RTOR) pilot program
.
Adagrasib was granted Breakthrough Therapy Designation by the U.
S.
FDA in June last year
.
References: 1.
Frederick LL, et al.
Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.
N Engl J Med 2022; 386:640-654.
DOI: 10.
1056/NEJMoa2116133 https:// /doi/full/10.
1056/NEJMoa21161332.
Bishop MR, et al.
Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.
N Engl J Med 2022; 386:629-639.
DOI: 10.
1056/NEJMoa2116596 https:// https://mp.
weixin.
qq.
com/s/lCPFpeUZd5fIOCaLo9ZOSQ
