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On June 10, 2021, the official website of China National Medical Products Administration (NMPA) showed that the PD-1 immune checkpoint inhibitor pembrolizumab injection (commonly known as "K drug" in China, trade name: Kerida®) The indication for the treatment of colorectal cancer (marketing application acceptance number: JXSS2000063 country) was officially approved
.
Previously, based on a global multi-center, randomized, controlled, open-label clinical study KEYNOTE-177, Drug K has been approved in the United States and the European Union as a single agent for the first-line treatment of microsatellites in June 2020 and January 2021, respectively.
Unresectable/metastatic colorectal cancer (mCRC) characterized by high instability (MSI-H)/mismatch repair defect (dMMR)
.
The KEYNOTE-177 study is the first head-to-head phase III clinical study to compare PD-1 monotherapy and standard chemotherapy for first-line MSI-H/dMMR metastatic colorectal cancer treatment with positive results
.
The results of the study were first released at the American Society of Clinical Oncology (ASCO) conference in 20201, which caused a sensation
.
The KEYNOTE-177 study was published in the New England Journal of Medicine in December 2020
.
The just-concluded 2021 ASCO conference announced the final overall survival (OS) results of KEYNOTE-177, reaffirming its status as a first-line treatment
.
The results showed that 2, after a median follow-up of more than 44 months (44.
5 [36.
0-60.
3] months in the K drug treatment group, 44.
4 [36.
2-58.
6] months in the control group), the median OS of the K drug group had not yet reached, and the control The median OS in the group was 36.
7 months, and the risk of death was reduced by 26% (HR 0.
74; 95% CI, 0.
53-1.
03; P=0.
0359); 60% of the control group received PD-1/PD-L1 after disease progression Under the interference of immune checkpoint inhibitor therapy, the K drug treatment group still showed a long-term OS benefit trend.
At 36 months, 61% of the K drug group patients were still alive, and the control group was 50%
.
KEYNOTE-177 Final OS analysis results 2 The results of the study released in ASCO this time also updated the data analysis results of the progression-free survival (PFS), objective response rate (ORR) and safety and other secondary endpoints: The median PFS was 16.
5 months, which was twice that of the control chemotherapy group (8.
2 months) (HR=0.
59; 95%CI: 0.
45~0.
79; P=0.
0002); the final ORR of the K drug group was 45.
1% (20 CR, 49 PR), the control group was 33.
1% (6 CR, 45 PR); the median duration of remission (DOR) in the K drug group did not reach (2.
3+~53.
5+), and the control group was 10.
6 months (2.
8~ 48.
3+); The incidence of treatment-related adverse events (TRAE) above grade 3 in the K drug group was 21.
6%, and the control group was 66.
4%
.
Based on the same research results, this new indication was approved in China, making Drug K the first PD-1 immune checkpoint inhibitor in China to guide clinical practice based on MSI/MMR status
.
This is also after the first-line treatment of advanced non-small cell lung cancer by K drug, the second-line treatment of locally advanced and metastatic esophageal squamous cell carcinoma, and the first-line treatment of unresectable recurrent head and neck squamous cell carcinoma.
The indication of accurate PD-1 therapy under the guidance of biomarkers has made K drug the "king of precision immunity" well-deserved in China
.
The Global Cancer Research (GLOBOCAN) statistical report released this year by the International Agency for Research on Cancer of the World Health Organization 3 shows that in 2020, about 550,000 new colorectal cancer patients will be added in China, and about 280,000 will die of colorectal cancer, second only to lung cancer.
The overall incidence of cancer is second, and the incidence of digestive tract tumors is the first
.
It is expected that medicine K will bring not only the possibility of long-term survival to this part of mCRC patients, but also high-quality survival of "no chemotherapy"
.
References: 1.
Thierry Andre, First-line therapy of pembrolizumab versus standard of care (SOC) in microsatelliteinstability-high/mismatch repair deficient metastatic colorectal cancer: The phase III, KEYNOTE-177 study.
ASCO 2020, LBA42.
Thierry Andre et al.
, Final overall survival for the phase III KN177 study: Pembrolizumab versus chemotherapy in microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC).
2021 ASCO Abstract 3500, 3.
.
Previously, based on a global multi-center, randomized, controlled, open-label clinical study KEYNOTE-177, Drug K has been approved in the United States and the European Union as a single agent for the first-line treatment of microsatellites in June 2020 and January 2021, respectively.
Unresectable/metastatic colorectal cancer (mCRC) characterized by high instability (MSI-H)/mismatch repair defect (dMMR)
.
The KEYNOTE-177 study is the first head-to-head phase III clinical study to compare PD-1 monotherapy and standard chemotherapy for first-line MSI-H/dMMR metastatic colorectal cancer treatment with positive results
.
The results of the study were first released at the American Society of Clinical Oncology (ASCO) conference in 20201, which caused a sensation
.
The KEYNOTE-177 study was published in the New England Journal of Medicine in December 2020
.
The just-concluded 2021 ASCO conference announced the final overall survival (OS) results of KEYNOTE-177, reaffirming its status as a first-line treatment
.
The results showed that 2, after a median follow-up of more than 44 months (44.
5 [36.
0-60.
3] months in the K drug treatment group, 44.
4 [36.
2-58.
6] months in the control group), the median OS of the K drug group had not yet reached, and the control The median OS in the group was 36.
7 months, and the risk of death was reduced by 26% (HR 0.
74; 95% CI, 0.
53-1.
03; P=0.
0359); 60% of the control group received PD-1/PD-L1 after disease progression Under the interference of immune checkpoint inhibitor therapy, the K drug treatment group still showed a long-term OS benefit trend.
At 36 months, 61% of the K drug group patients were still alive, and the control group was 50%
.
KEYNOTE-177 Final OS analysis results 2 The results of the study released in ASCO this time also updated the data analysis results of the progression-free survival (PFS), objective response rate (ORR) and safety and other secondary endpoints: The median PFS was 16.
5 months, which was twice that of the control chemotherapy group (8.
2 months) (HR=0.
59; 95%CI: 0.
45~0.
79; P=0.
0002); the final ORR of the K drug group was 45.
1% (20 CR, 49 PR), the control group was 33.
1% (6 CR, 45 PR); the median duration of remission (DOR) in the K drug group did not reach (2.
3+~53.
5+), and the control group was 10.
6 months (2.
8~ 48.
3+); The incidence of treatment-related adverse events (TRAE) above grade 3 in the K drug group was 21.
6%, and the control group was 66.
4%
.
Based on the same research results, this new indication was approved in China, making Drug K the first PD-1 immune checkpoint inhibitor in China to guide clinical practice based on MSI/MMR status
.
This is also after the first-line treatment of advanced non-small cell lung cancer by K drug, the second-line treatment of locally advanced and metastatic esophageal squamous cell carcinoma, and the first-line treatment of unresectable recurrent head and neck squamous cell carcinoma.
The indication of accurate PD-1 therapy under the guidance of biomarkers has made K drug the "king of precision immunity" well-deserved in China
.
The Global Cancer Research (GLOBOCAN) statistical report released this year by the International Agency for Research on Cancer of the World Health Organization 3 shows that in 2020, about 550,000 new colorectal cancer patients will be added in China, and about 280,000 will die of colorectal cancer, second only to lung cancer.
The overall incidence of cancer is second, and the incidence of digestive tract tumors is the first
.
It is expected that medicine K will bring not only the possibility of long-term survival to this part of mCRC patients, but also high-quality survival of "no chemotherapy"
.
References: 1.
Thierry Andre, First-line therapy of pembrolizumab versus standard of care (SOC) in microsatelliteinstability-high/mismatch repair deficient metastatic colorectal cancer: The phase III, KEYNOTE-177 study.
ASCO 2020, LBA42.
Thierry Andre et al.
, Final overall survival for the phase III KN177 study: Pembrolizumab versus chemotherapy in microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC).
2021 ASCO Abstract 3500, 3.
