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▎Tri-negative breast cancer (TNBC), edited by WuXi AppTec's content team, is a refractory breast cancer that is highly aggressive, easily resistant to chemotherapy, and has a very poor prognosis.
Its treatment is an urgent clinical problem.
For a long time, Chemotherapy is the only standard treatment option.
At present, there is a promising new drug that is expected to better extend the lives of patients with triple-negative breast cancer.
In the phase 3 trial, in patients with refractory metastatic triple-negative breast cancer, compared with chemotherapy, the drug called sacituzumab govitecan brought about 3 times the progression-free survival and 2 times the overall survival.
, 7 times the objective remission rate.
In early 2019, a phase 1/2 clinical trial published in the New England Journal of Medicine (NEJM) showed that sacituzumab govitecan (SG, Trodelvy) is significantly better than chemotherapy in patients with metastatic triple-negative breast cancer.
At the 2020 European Society of Oncology (ESMO) annual meeting, the preliminary data of the Phase 3 clinical trial ASCENT of this drug for the treatment of patients with metastatic triple-negative breast cancer was announced.
Recently, the detailed results of this phase 3 study were officially published again in NEJM.
Screenshot source: NEJM official website Sacituzumab govitecan is a second-generation antibody-conjugated drug.
It consists of an antibody targeting Trop-2 (human trophoblast cell surface antigen 2) and SN-38 (topoisomerase I inhibitor) through a proprietary linker.
, Topoisomerase I inhibitor) coupling.
The Trop-2 antibody part can target and bind to the corresponding cancer cell surface receptors, and the entire ADC drug is swallowed into the cancer cells, and then the chemotherapeutic drug SN-38 is released in the cancer cells, so as to achieve the purpose of killing tumor cells accurately.
It is like installing GPS positioning on chemotherapy drugs, which can accurately kill tumor cells, and significantly reduce toxic side effects while improving the efficacy.
ASCENT is a global randomized phase 3 trial designed to evaluate SG and single-agent chemotherapy (eribulin, vinorelbine, capecitabine or 468 patients with relapsed or refractory metastatic triple-negative breast cancer) Gemcitabine, selected by the physician) compared to its efficacy and safety.
In the trial, 235 patients were randomly assigned to receive SG treatment, and 233 patients received chemotherapy; all patients had previously used taxanes.
The primary endpoint is progression-free survival in patients without brain metastases.
The results showed that the median progression-free survival in the SG group was 5.
6 months, while that in the chemotherapy group was 1.
7 months.
SG reduced the risk of disease progression or death by 59% (HR=0.
41; 95% CI, 0.
32 ~ 0.
52; P < 0.
001); the median overall survival of the SG group was 12.
1 months and that of the chemotherapy group was 6.
7 months.
SG reduced the risk of death by 52% (HR=0.
48; 95% CI, 0.
38-0.
59; P <0.
001).
The objective remission rate after receiving SG was 35%, and the remission rate achieved after chemotherapy was 5%.
▲ Patients with metastatic TNBC receive standard chemotherapy or SG treatment.
Compared with single-agent chemotherapy, SG's progression-free survival and overall survival are significantly prolonged, and bone marrow toxicity and diarrhea are more frequent (picture source: reference [1]) In patients with metastatic triple-negative breast cancer, ≥3 The key treatment-related adverse events of grade include neutropenia (51% in the SG group and 33% in the chemotherapy group), leukopenia (10% and 5%), diarrhea (10% and <1%), and anemia (8% and 5%) and febrile neutropenia (6% and 2%).
There were 3 deaths due to adverse events in each group; no deaths were related to SG treatment.
Dr.
Aditya Bardia, principal investigator and attending physician at the Department of Medical Oncology at Mass General Cancer Center, said: "These statistically significant discoveries give patients with this devastating disease Brings hope.
We need to make persistent efforts to accelerate the further development of combination therapies for breast cancer patients.
We hope that it will not only improve the prognosis of patients, but also serve as a first-line therapy to prevent the spread of triple-negative breast cancer in time.
"In April of this year, sacituzumab govitecan has already It is fully approved by the US FDA for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer adult patients who have received more than two systemic treatments.
The drug has also been approved for Phase 3 clinical trials in China to treat metastatic triple-negative breast cancer and advanced urothelial carcinoma (mUC) that have received at least 2 lines of previous treatment.
Expect more patients to benefit from this drug! Recommended reading ESMO highlights recommendation: The most difficult to treat breast cancer, immunotherapy, antibody-conjugated drugs have a promising clinical prospect! Sun Yat-sen University Cancer Center's research wins JAMA, triple-negative breast cancer maintenance treatment improves 5-year disease-free survival rate "most toxic" breast cancer survival rate is improved! The precision adjuvant therapy "Fudan Program" was published in the Journal of the American Medical Association-Oncology and The Lancet-Oncology: Professor Xu Binghe led the second-line treatment of HER2-positive breast cancer with Chinese innovative drug pyrrotinib and received support again! JAMA Sub-Journal: These advanced breast cancers are expected to be cured! Chinese scholars propose to modify the disease staging references: [1] Novel agent shows promise in treating the most aggressive type of breast cancer.
Retrieved 21-APR-2021, from mgh-nas041921.
php[2] Aditya Bardia, MD, et al.
Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer (April 22, 2021), N Engl J Med 2021; 384:1529-1541.
DOI: 10.
1056/NEJMoa2028485Note : This article aims to introduce the progress of medical and health research, not to recommend treatment options.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
Its treatment is an urgent clinical problem.
For a long time, Chemotherapy is the only standard treatment option.
At present, there is a promising new drug that is expected to better extend the lives of patients with triple-negative breast cancer.
In the phase 3 trial, in patients with refractory metastatic triple-negative breast cancer, compared with chemotherapy, the drug called sacituzumab govitecan brought about 3 times the progression-free survival and 2 times the overall survival.
, 7 times the objective remission rate.
In early 2019, a phase 1/2 clinical trial published in the New England Journal of Medicine (NEJM) showed that sacituzumab govitecan (SG, Trodelvy) is significantly better than chemotherapy in patients with metastatic triple-negative breast cancer.
At the 2020 European Society of Oncology (ESMO) annual meeting, the preliminary data of the Phase 3 clinical trial ASCENT of this drug for the treatment of patients with metastatic triple-negative breast cancer was announced.
Recently, the detailed results of this phase 3 study were officially published again in NEJM.
Screenshot source: NEJM official website Sacituzumab govitecan is a second-generation antibody-conjugated drug.
It consists of an antibody targeting Trop-2 (human trophoblast cell surface antigen 2) and SN-38 (topoisomerase I inhibitor) through a proprietary linker.
, Topoisomerase I inhibitor) coupling.
The Trop-2 antibody part can target and bind to the corresponding cancer cell surface receptors, and the entire ADC drug is swallowed into the cancer cells, and then the chemotherapeutic drug SN-38 is released in the cancer cells, so as to achieve the purpose of killing tumor cells accurately.
It is like installing GPS positioning on chemotherapy drugs, which can accurately kill tumor cells, and significantly reduce toxic side effects while improving the efficacy.
ASCENT is a global randomized phase 3 trial designed to evaluate SG and single-agent chemotherapy (eribulin, vinorelbine, capecitabine or 468 patients with relapsed or refractory metastatic triple-negative breast cancer) Gemcitabine, selected by the physician) compared to its efficacy and safety.
In the trial, 235 patients were randomly assigned to receive SG treatment, and 233 patients received chemotherapy; all patients had previously used taxanes.
The primary endpoint is progression-free survival in patients without brain metastases.
The results showed that the median progression-free survival in the SG group was 5.
6 months, while that in the chemotherapy group was 1.
7 months.
SG reduced the risk of disease progression or death by 59% (HR=0.
41; 95% CI, 0.
32 ~ 0.
52; P < 0.
001); the median overall survival of the SG group was 12.
1 months and that of the chemotherapy group was 6.
7 months.
SG reduced the risk of death by 52% (HR=0.
48; 95% CI, 0.
38-0.
59; P <0.
001).
The objective remission rate after receiving SG was 35%, and the remission rate achieved after chemotherapy was 5%.
▲ Patients with metastatic TNBC receive standard chemotherapy or SG treatment.
Compared with single-agent chemotherapy, SG's progression-free survival and overall survival are significantly prolonged, and bone marrow toxicity and diarrhea are more frequent (picture source: reference [1]) In patients with metastatic triple-negative breast cancer, ≥3 The key treatment-related adverse events of grade include neutropenia (51% in the SG group and 33% in the chemotherapy group), leukopenia (10% and 5%), diarrhea (10% and <1%), and anemia (8% and 5%) and febrile neutropenia (6% and 2%).
There were 3 deaths due to adverse events in each group; no deaths were related to SG treatment.
Dr.
Aditya Bardia, principal investigator and attending physician at the Department of Medical Oncology at Mass General Cancer Center, said: "These statistically significant discoveries give patients with this devastating disease Brings hope.
We need to make persistent efforts to accelerate the further development of combination therapies for breast cancer patients.
We hope that it will not only improve the prognosis of patients, but also serve as a first-line therapy to prevent the spread of triple-negative breast cancer in time.
"In April of this year, sacituzumab govitecan has already It is fully approved by the US FDA for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer adult patients who have received more than two systemic treatments.
The drug has also been approved for Phase 3 clinical trials in China to treat metastatic triple-negative breast cancer and advanced urothelial carcinoma (mUC) that have received at least 2 lines of previous treatment.
Expect more patients to benefit from this drug! Recommended reading ESMO highlights recommendation: The most difficult to treat breast cancer, immunotherapy, antibody-conjugated drugs have a promising clinical prospect! Sun Yat-sen University Cancer Center's research wins JAMA, triple-negative breast cancer maintenance treatment improves 5-year disease-free survival rate "most toxic" breast cancer survival rate is improved! The precision adjuvant therapy "Fudan Program" was published in the Journal of the American Medical Association-Oncology and The Lancet-Oncology: Professor Xu Binghe led the second-line treatment of HER2-positive breast cancer with Chinese innovative drug pyrrotinib and received support again! JAMA Sub-Journal: These advanced breast cancers are expected to be cured! Chinese scholars propose to modify the disease staging references: [1] Novel agent shows promise in treating the most aggressive type of breast cancer.
Retrieved 21-APR-2021, from mgh-nas041921.
php[2] Aditya Bardia, MD, et al.
Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer (April 22, 2021), N Engl J Med 2021; 384:1529-1541.
DOI: 10.
1056/NEJMoa2028485Note : This article aims to introduce the progress of medical and health research, not to recommend treatment options.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
