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Recently, drug K (pembrolizumab) has been approved in China for a new indication for gastrointestinal tumors, for KRAS, NRAS and BRAF genes are all wild-type, metastatic or unresectable high microsatellite instability or mismatch Repair gene defect (MSI-H/dMMR) first-line treatment for patients with colorectal cancer
.
Up to now, K drug has been approved for 7 indications in 5 major tumor types in China
.
This approval is based on data from a large global multi-center clinical study KEYNOTE-177.
The latest overall survival (OS) results show that drug K has outperformed standard chemotherapy in the first-line treatment of MSI-H/dMMR bowel cancer.
3 The annual survival rate is as high as 61%, and the median OS has not yet reached, or will exceed 4 years! This is also the only immunotherapy approved for the first-line treatment of MSI-H/dMMR advanced colorectal cancer in China and even in the world, marking the official start of the immunotherapy era in the domestic colorectal cancer treatment field
.
Domestic bowel cancer patients are in place in one step, ushering in first-line immunotherapy As early as May 2017, the U.
S.
Food and Drug Administration (FDA) has approved K drug for all unresectable or metastatic entities with MSI-H or dMMR characteristics Second-line treatment of tumors, including colorectal cancer, this is the first tumor treatment method approved based on biomarkers for all types of cancer
.
In other words, there is no limit to the type of cancer, as long as the test result shows MSI-H or dMMR, these tumor patients can try K drugs for treatment after first-line treatment
.
However, many doctors and patients are thinking, if it is used in first-line treatment, the patient's physical immunity will be better, and the effect will be better? It is based on this idea that the clinical trial named KEYNOTE-177 that we mentioned earlier was carried out
.
In June 2020, based on the interim results of the KEYNOTE-177 study, the FDA approved drug K for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer
.
It can be seen that it took more than three years for the FDA to be approved from the back-line treatment to the first-line treatment! The domestic bowel cancer patients are about to usher in one step, and the first-line treatment will be approved directly, which greatly promotes the progress of the first-line treatment of bowel cancer in China, so that Chinese patients can benefit from immunotherapy as soon as possible
.
The 3-year survival rate is as high as 61%, and the median OS may be more than 4 years.
At the just-concluded annual meeting of the American Society of Clinical Oncology (ASCO), the KEYNOTE-177 study also updated the data results.
Let’s take a look
.
Trial design: The KEYNOTE-177 study enrolled 307 patients with unresectable or metastatic MSI-H/dMMR colorectal cancer.
They were randomly divided into the K drug group and the standard chemotherapy group at a ratio of 1:1, among which patients in the chemotherapy group If there is disease progression that is ineffective in treatment, it can be crossed over to the K-drug group to continue treatment
.
Tumor remission ■ The objective response rate (ORR) of the K drug group was 45.
1%, of which 83.
5% of patients had tumor remission lasting for at least 2 years.
The median duration of response (DoR) has not been reached, which means that the K drug has achieved the effect of tumor remission.
More lasting; ■ The complete response rate (CRR) of the K drug group was 13.
1%, which was more than three times that of the chemotherapy group 3.
9%, which means that more patients with advanced bowel cancer can achieve complete tumor disappearance
.
Survival period ■ The current follow-up time is close to 4 years, and about 60% of the patients in the chemotherapy group chose immunotherapy in the follow-up treatment, so the data of OS in the chemotherapy group was further increased by the impact of immunotherapy; ■ K drug group The median progression-free survival (PFS) of the chemotherapy group and the chemotherapy group were 16.
5 months and 8.
2 months, respectively, which almost doubled; ■ The median OS of the K drug group has not yet reached (currently at least 49.
2 months), which has reduced 26% For the risk of death, the median OS of the chemotherapy group was 36.
7 months, while the median OS of patients with advanced bowel cancer who used conventional chemotherapy in the past was often less than two years; ■ The 3-year survival rate of the K drug group and the chemotherapy group was 61%, respectively And 50%, and the follow-up survival curve is almost parallel to the coordinate axis, which means that immunotherapy for follow-up treatment can also bring long-term survival benefits.
However, if K drugs are used directly in the first-line treatment, more patients with advanced bowel cancer will live.
After 5 years, it may even be "cured"
.
Safety ■ The proportion of treatment-related adverse reactions (TRAE) of grade 3 or above was 21.
6% in the K drug group and 66.
4% in the chemotherapy group
.
The latest data from the KEYNOTE-177 study once again verified that immunotherapy was used early and well, and K drug increased the 3-year survival rate of patients with MSI-H/dMMR advanced colorectal cancer to 61%, giving more patients a chance to live beyond 5 years , Is expected to be "cured"
.
More importantly, the efficacy of drug K as a single agent is far superior to other combination chemotherapy regimens, whether it is dual or triple drugs
.
Moreover, the combined chemotherapy regimen needs to be administered once every two weeks, while the K drug is only used once every three weeks, or even once every six weeks, which is safer and more convenient, and greatly improves the quality of life of patients with advanced bowel cancer
.
This year's Chinese Society of Clinical Oncology (CSCO) Colorectal Cancer (CRC) Diagnosis and Treatment Guidelines are updated.
Drug K has also been included in the Class I recommendation for the first-line treatment of MSI-H/dMMR colorectal cancer patients.
Drug K will become the new standard for the first-line treatment of colorectal cancer.
.
I believe that the approval of pembrolizumab will enable Chinese patients with bowel cancer to usher in a new choice of immunity, and enter the era of immunity in one step, and live together for three, five years or even longer! Click below to learn more about the past review of clinical trial projects.
Swipe to view more past content.
.
Up to now, K drug has been approved for 7 indications in 5 major tumor types in China
.
This approval is based on data from a large global multi-center clinical study KEYNOTE-177.
The latest overall survival (OS) results show that drug K has outperformed standard chemotherapy in the first-line treatment of MSI-H/dMMR bowel cancer.
3 The annual survival rate is as high as 61%, and the median OS has not yet reached, or will exceed 4 years! This is also the only immunotherapy approved for the first-line treatment of MSI-H/dMMR advanced colorectal cancer in China and even in the world, marking the official start of the immunotherapy era in the domestic colorectal cancer treatment field
.
Domestic bowel cancer patients are in place in one step, ushering in first-line immunotherapy As early as May 2017, the U.
S.
Food and Drug Administration (FDA) has approved K drug for all unresectable or metastatic entities with MSI-H or dMMR characteristics Second-line treatment of tumors, including colorectal cancer, this is the first tumor treatment method approved based on biomarkers for all types of cancer
.
In other words, there is no limit to the type of cancer, as long as the test result shows MSI-H or dMMR, these tumor patients can try K drugs for treatment after first-line treatment
.
However, many doctors and patients are thinking, if it is used in first-line treatment, the patient's physical immunity will be better, and the effect will be better? It is based on this idea that the clinical trial named KEYNOTE-177 that we mentioned earlier was carried out
.
In June 2020, based on the interim results of the KEYNOTE-177 study, the FDA approved drug K for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer
.
It can be seen that it took more than three years for the FDA to be approved from the back-line treatment to the first-line treatment! The domestic bowel cancer patients are about to usher in one step, and the first-line treatment will be approved directly, which greatly promotes the progress of the first-line treatment of bowel cancer in China, so that Chinese patients can benefit from immunotherapy as soon as possible
.
The 3-year survival rate is as high as 61%, and the median OS may be more than 4 years.
At the just-concluded annual meeting of the American Society of Clinical Oncology (ASCO), the KEYNOTE-177 study also updated the data results.
Let’s take a look
.
Trial design: The KEYNOTE-177 study enrolled 307 patients with unresectable or metastatic MSI-H/dMMR colorectal cancer.
They were randomly divided into the K drug group and the standard chemotherapy group at a ratio of 1:1, among which patients in the chemotherapy group If there is disease progression that is ineffective in treatment, it can be crossed over to the K-drug group to continue treatment
.
Tumor remission ■ The objective response rate (ORR) of the K drug group was 45.
1%, of which 83.
5% of patients had tumor remission lasting for at least 2 years.
The median duration of response (DoR) has not been reached, which means that the K drug has achieved the effect of tumor remission.
More lasting; ■ The complete response rate (CRR) of the K drug group was 13.
1%, which was more than three times that of the chemotherapy group 3.
9%, which means that more patients with advanced bowel cancer can achieve complete tumor disappearance
.
Survival period ■ The current follow-up time is close to 4 years, and about 60% of the patients in the chemotherapy group chose immunotherapy in the follow-up treatment, so the data of OS in the chemotherapy group was further increased by the impact of immunotherapy; ■ K drug group The median progression-free survival (PFS) of the chemotherapy group and the chemotherapy group were 16.
5 months and 8.
2 months, respectively, which almost doubled; ■ The median OS of the K drug group has not yet reached (currently at least 49.
2 months), which has reduced 26% For the risk of death, the median OS of the chemotherapy group was 36.
7 months, while the median OS of patients with advanced bowel cancer who used conventional chemotherapy in the past was often less than two years; ■ The 3-year survival rate of the K drug group and the chemotherapy group was 61%, respectively And 50%, and the follow-up survival curve is almost parallel to the coordinate axis, which means that immunotherapy for follow-up treatment can also bring long-term survival benefits.
However, if K drugs are used directly in the first-line treatment, more patients with advanced bowel cancer will live.
After 5 years, it may even be "cured"
.
Safety ■ The proportion of treatment-related adverse reactions (TRAE) of grade 3 or above was 21.
6% in the K drug group and 66.
4% in the chemotherapy group
.
The latest data from the KEYNOTE-177 study once again verified that immunotherapy was used early and well, and K drug increased the 3-year survival rate of patients with MSI-H/dMMR advanced colorectal cancer to 61%, giving more patients a chance to live beyond 5 years , Is expected to be "cured"
.
More importantly, the efficacy of drug K as a single agent is far superior to other combination chemotherapy regimens, whether it is dual or triple drugs
.
Moreover, the combined chemotherapy regimen needs to be administered once every two weeks, while the K drug is only used once every three weeks, or even once every six weeks, which is safer and more convenient, and greatly improves the quality of life of patients with advanced bowel cancer
.
This year's Chinese Society of Clinical Oncology (CSCO) Colorectal Cancer (CRC) Diagnosis and Treatment Guidelines are updated.
Drug K has also been included in the Class I recommendation for the first-line treatment of MSI-H/dMMR colorectal cancer patients.
Drug K will become the new standard for the first-line treatment of colorectal cancer.
.
I believe that the approval of pembrolizumab will enable Chinese patients with bowel cancer to usher in a new choice of immunity, and enter the era of immunity in one step, and live together for three, five years or even longer! Click below to learn more about the past review of clinical trial projects.
Swipe to view more past content.
