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This article is from the NEJM Journal Watch A New Therapeutic Option for Advanced Urothelial Cancer.
Commentary author: Robert Dreicer, MD, MS, MACP, FASCO antibody-drug conjugate sacituzumab govitecan makes platinum Patients with disease progression after similar chemotherapy and immunotherapy achieved an objective remission rate of 27%
.
Although there are many new drugs to treat advanced urothelial cancer, it is still a highly fatal disease and more treatment options are still needed
.
The researchers conducted a phase II trial funded by pharmaceutical companies for sacituzumab govitecan (SG).
SG is an antibody-drug conjugate targeting trophoblast cell surface antigen 2, and trophoblast cell surface antigen 2 is in most Highly expressed transmembrane glycoprotein on the surface of urothelial cancer cells
.
The inclusion criteria of patients were advanced urothelial carcinoma and progressed after receiving platinum-based chemotherapy and immune checkpoint inhibitor treatment
.
SG is administered intravenously (10 mg/kg) on the 1st and 8th day of each 21-day cycle until the disease progresses or unacceptable toxicity occurs
.
The primary endpoint is the objective response rate determined by blinded independent centralized review
.
Among 113 patients (75% were men; median age 66 years), 66% had visceral involvement and 34% had liver metastases
.
The median number of cycles that the patient received treatment was 6, and the median duration of treatment was 3.
7 months
.
The objective response rate was 27.
4%, and 6 patients had a complete response
.
At a median follow-up of 9.
1 months, the median duration of remission was 7.
2 months, and the median overall survival was 5.
4 months
.
Among the 10 patients treated with enfortumab vedotin, 3 achieved partial remission
.
Grade 3 or higher toxicities include neutropenia (35%), anemia (14%), febrile neutropenia (10%) and diarrhea (10%); 6% of patients are due to toxicity Stop treatment
.
Comments In April 2021, on the basis of this study, the US FDA has accelerated the approval of SG for the treatment of patients who have previously received platinum-based regimens and immune checkpoint inhibitors
.
A phase 3 confirmatory study in patients with advanced urothelial carcinoma is ongoing
.
The toxicity characteristics of SG seem to be somewhat different from those of enfortumab vedotin, and the anti-tumor activity level of SG after enfortumab treatment has not yet been determined
.
The reviewed article Tagawa ST et al.
TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors.
J Clin Oncol 2021 Apr 30; [e- pub].
(https://doi.
org/10.
1200/JCO.
20.
03489) Related reading NEJM Journal Watch The NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and understand Use the latest developments
.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat
.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM)
.
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group
.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities
.
Commentary author: Robert Dreicer, MD, MS, MACP, FASCO antibody-drug conjugate sacituzumab govitecan makes platinum Patients with disease progression after similar chemotherapy and immunotherapy achieved an objective remission rate of 27%
.
Although there are many new drugs to treat advanced urothelial cancer, it is still a highly fatal disease and more treatment options are still needed
.
The researchers conducted a phase II trial funded by pharmaceutical companies for sacituzumab govitecan (SG).
SG is an antibody-drug conjugate targeting trophoblast cell surface antigen 2, and trophoblast cell surface antigen 2 is in most Highly expressed transmembrane glycoprotein on the surface of urothelial cancer cells
.
The inclusion criteria of patients were advanced urothelial carcinoma and progressed after receiving platinum-based chemotherapy and immune checkpoint inhibitor treatment
.
SG is administered intravenously (10 mg/kg) on the 1st and 8th day of each 21-day cycle until the disease progresses or unacceptable toxicity occurs
.
The primary endpoint is the objective response rate determined by blinded independent centralized review
.
Among 113 patients (75% were men; median age 66 years), 66% had visceral involvement and 34% had liver metastases
.
The median number of cycles that the patient received treatment was 6, and the median duration of treatment was 3.
7 months
.
The objective response rate was 27.
4%, and 6 patients had a complete response
.
At a median follow-up of 9.
1 months, the median duration of remission was 7.
2 months, and the median overall survival was 5.
4 months
.
Among the 10 patients treated with enfortumab vedotin, 3 achieved partial remission
.
Grade 3 or higher toxicities include neutropenia (35%), anemia (14%), febrile neutropenia (10%) and diarrhea (10%); 6% of patients are due to toxicity Stop treatment
.
Comments In April 2021, on the basis of this study, the US FDA has accelerated the approval of SG for the treatment of patients who have previously received platinum-based regimens and immune checkpoint inhibitors
.
A phase 3 confirmatory study in patients with advanced urothelial carcinoma is ongoing
.
The toxicity characteristics of SG seem to be somewhat different from those of enfortumab vedotin, and the anti-tumor activity level of SG after enfortumab treatment has not yet been determined
.
The reviewed article Tagawa ST et al.
TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors.
J Clin Oncol 2021 Apr 30; [e- pub].
(https://doi.
org/10.
1200/JCO.
20.
03489) Related reading NEJM Journal Watch The NEJM Journal Watch is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and understand Use the latest developments
.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat
.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM)
.
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group
.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities
.
