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▎The content team editor of WuXi AppTec.
At the upcoming 2021 American Society of Clinical Oncology (ASCO) annual meeting, three Chinese scholars in the field of breast cancer were selected for oral presentations (Oral Abstract Session).
The SYSUCC-002 research of Sun Yat-sen University Cancer Center that we have shared before, and the other two Chinese innovative drugs used in different subtypes of advanced breast cancer research are also attracting attention.
DAWNA-1 study: Dalpiciclib combined with fulvestrant in the treatment of HR+/HER2- advanced breast cancer.
Lead: Professor Xu Binghe, Cancer Hospital, Chinese Academy of Medical Sciences Screenshot source: ASCODalpiciclib (SHR6390) is an innovative CDK4 developed by Hengrui Medicine /6 inhibitor.
This randomized, double-blind, phase 3 trial showed that in HR+/HER2-advanced breast cancer that recurred or progressed after endocrine therapy, dalpiciclib combined with fulvestrant can be significantly better than placebo combined with fulvestrant Improve progression-free survival (PFS) with controllable safety.
Research findings support dalpiciclib combined with fulvestrant as a new treatment option for these patients.
The study included 361 patients with relapsed or advanced HR+/HER2- locally advanced or metastatic breast cancer after receiving endocrine therapy.
Patients were randomized 2:1 to receive dalpiciclib plus fulvestrant (n = 241) or placebo plus fulvestrant (n = 120).
The primary endpoint is PFS as assessed by the investigator.
As of November 15, 2020, 162 cases of disease progression or death have occurred (71.
4% of the estimated total), and a pre-planned interim analysis has been carried out.The median follow-up time was 10.
5 months.
Compared with placebo combined with fulvestrant, dalpiciclib combined with fulvestrant significantly improved the investigator’s assessment of PFS (median time 15.
7 months vs 7.
2 months), disease progression or risk of death Reduced by 58% (HR 0.
42 [95%CI 0.
31-0.
58]; P <0.
0001).
The Independent Committee (IRC) evaluated PFS unanimously.
The combination of dalpiciclib treatment also significantly extended the time interval between patients who need to receive the first subsequent chemotherapy (TFSCT, the median time has not reached 14.
2 months), and the risk was reduced by 53% (HR 0.
47 [95%CI 0.
32-0.
69]; P <0.
0001) .
The overall survival data is not yet mature.
In the dalpiciclib combined with fulvex group, the median duration of drug exposure was 9.
4 months and 9.
9 months, respectively.
In the placebo combined with fulvestrant group, the exposure time of fulvestrant was 6.
1 months.
The most common grade 3 or 4 (incidence rate ≥3%) adverse events in the Dalpiciclib combined with fulvex group were neutropenia (84.
2% vs 0%) and leukopenia (62.
1% vs 0%).
The treatment interruption rate due to adverse events in the Dalpiciclib combined with fulvex group was 2.
5%, and that in the placebo combined with fulvex group was 3.
3%.
The incidence of serious adverse events in the two groups was 5.
8% and 6.
7%, respectively.
FUTURE-C-PLUS study: Triple therapy for the first-line treatment of triple-negative breast cancer.
Lead: Professor Shao Zhimin, Director of the Department of General Surgery and Breast Surgery, Fudan University Cancer Hospital.
Screenshot source: ASCO This study shows that famitinib Agent) combined with Camrelizumab and nanoparticle albumin-bound (nab-) paclitaxel, used for the first-line treatment of immunomodulatory (IM) subtype triple-negative breast cancer, with good anti-tumor activity and controllable The toxicity. Famitinib is an innovative drug under development of Hengrui Medicine, which is a tyrosine kinase inhibitor targeting VEGFR-2, PDGFR and c-kit.
Carrelizumab is a humanized anti-PD-1 monoclonal antibody independently developed by Hengrui Medicine.
Previously, in the umbrella trial FUTURE study, carrelizumab (Camrelizumab) and nab-paclitaxel showed encouraging anti-tumor activity in patients with treated IM subtype metastatic triple-negative breast cancer, and objective remission The ORR reached 52.
6%.
Since anti-angiogenic agents are known to enhance the patient’s response to immune checkpoint inhibitors, this study further evaluated new triple-therapies in IM subtypes of advanced triple-negative breast cancer: famitinib, carrelizol The efficacy of anti-nab-paclitaxel.
This prospective single-arm phase 2 trial included 48 patients with untreated IM subtypes, unresectable locally advanced or metastatic triple-negative breast cancers between 18 and 70 years of age.
Patients receive triple therapy, treatment until the disease progresses, patients withdraw from treatment or have intolerable toxic effects, if there is no intolerable toxic effects, nab-P treatment for at least 6 cycles.
The primary endpoint is ORR.
The results showed that among all 48 intention-to-treat patients, 39 patients achieved objective remission, with an ORR of 81.
3%; among 46 per-protocol patients, 39 patients achieved objective remission.
Remission, ORR was 84.
8%.
The median response time was 1.
8 months.
The median follow-up time is 9.
0 months, and the data on progression-free survival (PFS) and duration of remission are not yet mature.
Thirty patients (62.
5%) are still receiving study treatment.
The 9-month PFS rate was 60.
2%. Grade 3 or 4 adverse events include neutropenia (33.
3%), anemia (10.
4%), hyperfebrile neutropenia (10.
4%), thrombocytopenia (8.
3%), hypertension (4.
2%) %), hypothyroidism (4.
2%), proteinuria (2.
1%), sepsis (2.
1%) and immune-related myocarditis (2.
1%).
6.
3% of patients discontinued the drug due to adverse events.
Two patients had serious adverse events related to treatment.
No deaths related to treatment were reported.
In addition, the results of targeted sequencing covering 484 genes indicate that GSK3A may have the potential to predict response to immunotherapy.
Related reading The efficacy is similar and the toxicity is lower.
Professor Yuan Zhongyu brings better first-line treatment of HR+/HER2+ advanced breast cancer | ASCO 2021 prolongs survival of liver cancer, Sun Yat-sen University Cancer Center brings two effective solutions | ASCO 2021 neoadjuvant targeted treatment of lung cancer, Can overall survival be prolonged? Professor Wu Yilong ASCO announced that prolonging the "cancer-free survival" of early lung cancer, immunotherapy reduces the risk of recurrence by 34% | How effective is the ASCO 2021 HPV vaccine and screening in preventing cancer? 17 years of big data on 6 cancers in the United States brings inspiration | ASCO 2021 reference: [1] Dalpiciclib versus placebo plus fulvestrant in HR+/HER2- advanced breast cancer that relapsed or progressed on previous endocrine therapy (DAWNA-1): A multicenter , randomized, phase 3 study.
Retrieved May 25, 2021, from https://meetinglibrary.
asco.
org/record/195721/abstract[2] Combination of famitinib with camrelizumab plus nab-paclitaxel as first-line treatment for patients with immunomodulatory advanced triple-negative breast cancer (FUTURE-C-PLUS): A prospective, single-arm, phase 2 study.
Retrieved May 25, 2021, from https://meetinglibrary.
asco.
org/record/196659/abstract Note: This article It is intended to introduce the progress of medical and health research, not to recommend treatment options. If you need guidance on the treatment plan, please go to a regular hospital for treatment.
At the upcoming 2021 American Society of Clinical Oncology (ASCO) annual meeting, three Chinese scholars in the field of breast cancer were selected for oral presentations (Oral Abstract Session).
The SYSUCC-002 research of Sun Yat-sen University Cancer Center that we have shared before, and the other two Chinese innovative drugs used in different subtypes of advanced breast cancer research are also attracting attention.
DAWNA-1 study: Dalpiciclib combined with fulvestrant in the treatment of HR+/HER2- advanced breast cancer.
Lead: Professor Xu Binghe, Cancer Hospital, Chinese Academy of Medical Sciences Screenshot source: ASCODalpiciclib (SHR6390) is an innovative CDK4 developed by Hengrui Medicine /6 inhibitor.
This randomized, double-blind, phase 3 trial showed that in HR+/HER2-advanced breast cancer that recurred or progressed after endocrine therapy, dalpiciclib combined with fulvestrant can be significantly better than placebo combined with fulvestrant Improve progression-free survival (PFS) with controllable safety.
Research findings support dalpiciclib combined with fulvestrant as a new treatment option for these patients.
The study included 361 patients with relapsed or advanced HR+/HER2- locally advanced or metastatic breast cancer after receiving endocrine therapy.
Patients were randomized 2:1 to receive dalpiciclib plus fulvestrant (n = 241) or placebo plus fulvestrant (n = 120).
The primary endpoint is PFS as assessed by the investigator.
As of November 15, 2020, 162 cases of disease progression or death have occurred (71.
4% of the estimated total), and a pre-planned interim analysis has been carried out.The median follow-up time was 10.
5 months.
Compared with placebo combined with fulvestrant, dalpiciclib combined with fulvestrant significantly improved the investigator’s assessment of PFS (median time 15.
7 months vs 7.
2 months), disease progression or risk of death Reduced by 58% (HR 0.
42 [95%CI 0.
31-0.
58]; P <0.
0001).
The Independent Committee (IRC) evaluated PFS unanimously.
The combination of dalpiciclib treatment also significantly extended the time interval between patients who need to receive the first subsequent chemotherapy (TFSCT, the median time has not reached 14.
2 months), and the risk was reduced by 53% (HR 0.
47 [95%CI 0.
32-0.
69]; P <0.
0001) .
The overall survival data is not yet mature.
In the dalpiciclib combined with fulvex group, the median duration of drug exposure was 9.
4 months and 9.
9 months, respectively.
In the placebo combined with fulvestrant group, the exposure time of fulvestrant was 6.
1 months.
The most common grade 3 or 4 (incidence rate ≥3%) adverse events in the Dalpiciclib combined with fulvex group were neutropenia (84.
2% vs 0%) and leukopenia (62.
1% vs 0%).
The treatment interruption rate due to adverse events in the Dalpiciclib combined with fulvex group was 2.
5%, and that in the placebo combined with fulvex group was 3.
3%.
The incidence of serious adverse events in the two groups was 5.
8% and 6.
7%, respectively.
FUTURE-C-PLUS study: Triple therapy for the first-line treatment of triple-negative breast cancer.
Lead: Professor Shao Zhimin, Director of the Department of General Surgery and Breast Surgery, Fudan University Cancer Hospital.
Screenshot source: ASCO This study shows that famitinib Agent) combined with Camrelizumab and nanoparticle albumin-bound (nab-) paclitaxel, used for the first-line treatment of immunomodulatory (IM) subtype triple-negative breast cancer, with good anti-tumor activity and controllable The toxicity. Famitinib is an innovative drug under development of Hengrui Medicine, which is a tyrosine kinase inhibitor targeting VEGFR-2, PDGFR and c-kit.
Carrelizumab is a humanized anti-PD-1 monoclonal antibody independently developed by Hengrui Medicine.
Previously, in the umbrella trial FUTURE study, carrelizumab (Camrelizumab) and nab-paclitaxel showed encouraging anti-tumor activity in patients with treated IM subtype metastatic triple-negative breast cancer, and objective remission The ORR reached 52.
6%.
Since anti-angiogenic agents are known to enhance the patient’s response to immune checkpoint inhibitors, this study further evaluated new triple-therapies in IM subtypes of advanced triple-negative breast cancer: famitinib, carrelizol The efficacy of anti-nab-paclitaxel.
This prospective single-arm phase 2 trial included 48 patients with untreated IM subtypes, unresectable locally advanced or metastatic triple-negative breast cancers between 18 and 70 years of age.
Patients receive triple therapy, treatment until the disease progresses, patients withdraw from treatment or have intolerable toxic effects, if there is no intolerable toxic effects, nab-P treatment for at least 6 cycles.
The primary endpoint is ORR.
The results showed that among all 48 intention-to-treat patients, 39 patients achieved objective remission, with an ORR of 81.
3%; among 46 per-protocol patients, 39 patients achieved objective remission.
Remission, ORR was 84.
8%.
The median response time was 1.
8 months.
The median follow-up time is 9.
0 months, and the data on progression-free survival (PFS) and duration of remission are not yet mature.
Thirty patients (62.
5%) are still receiving study treatment.
The 9-month PFS rate was 60.
2%. Grade 3 or 4 adverse events include neutropenia (33.
3%), anemia (10.
4%), hyperfebrile neutropenia (10.
4%), thrombocytopenia (8.
3%), hypertension (4.
2%) %), hypothyroidism (4.
2%), proteinuria (2.
1%), sepsis (2.
1%) and immune-related myocarditis (2.
1%).
6.
3% of patients discontinued the drug due to adverse events.
Two patients had serious adverse events related to treatment.
No deaths related to treatment were reported.
In addition, the results of targeted sequencing covering 484 genes indicate that GSK3A may have the potential to predict response to immunotherapy.
Related reading The efficacy is similar and the toxicity is lower.
Professor Yuan Zhongyu brings better first-line treatment of HR+/HER2+ advanced breast cancer | ASCO 2021 prolongs survival of liver cancer, Sun Yat-sen University Cancer Center brings two effective solutions | ASCO 2021 neoadjuvant targeted treatment of lung cancer, Can overall survival be prolonged? Professor Wu Yilong ASCO announced that prolonging the "cancer-free survival" of early lung cancer, immunotherapy reduces the risk of recurrence by 34% | How effective is the ASCO 2021 HPV vaccine and screening in preventing cancer? 17 years of big data on 6 cancers in the United States brings inspiration | ASCO 2021 reference: [1] Dalpiciclib versus placebo plus fulvestrant in HR+/HER2- advanced breast cancer that relapsed or progressed on previous endocrine therapy (DAWNA-1): A multicenter , randomized, phase 3 study.
Retrieved May 25, 2021, from https://meetinglibrary.
asco.
org/record/195721/abstract[2] Combination of famitinib with camrelizumab plus nab-paclitaxel as first-line treatment for patients with immunomodulatory advanced triple-negative breast cancer (FUTURE-C-PLUS): A prospective, single-arm, phase 2 study.
Retrieved May 25, 2021, from https://meetinglibrary.
asco.
org/record/196659/abstract Note: This article It is intended to introduce the progress of medical and health research, not to recommend treatment options. If you need guidance on the treatment plan, please go to a regular hospital for treatment.
