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On May 19, 2021, the official website of the American Society of Clinical Oncology (ASCO) announced the results of the Chinese population data analysis of the Phase III clinical study KEYNOTE-590, which will be officially released at the 2021 ASCO Conference (June 4-June 8).
ASCO official website announced the results of KEYNOTE-590 Chinese population data analysis 1KEYNOTE-590 is a global multi-center, randomized, double-blind, phase III clinical study aimed at evaluating pembrolizumab (commonly known as “K drug” in China) combined with cis Platinum and 5-fluorouracil (5-FU), compared with the efficacy and safety of cisplatin and 5-FU in the first-line treatment of unresectable locally advanced or metastatic esophageal cancer.
The interim analysis results of the study with a median follow-up of 10.
8 months caused a sensation after the official publication of the European Society of Internal Medicine (ESMO) conference in 2020 for the first time, and became the first to show that the first-line treatment of advanced esophageal cancer with immune combined chemotherapy is significantly better than chemotherapy.
III Phase clinical research.
The results of the data analysis of the Chinese subgroups released this time show that among the 107 cases of Chinese esophageal cancer (esophageal squamous cell carcinoma accounted for 98.
1%), compared with the control group, the K drug combined with platinum-containing chemotherapy can reduce the first-line treatment by 49% Risk of death (HR, 0.
51; 95% CI, 0.
32-0.
81)1.
The results of the KEYNOTE-590 overall population data analysis published by ESMO in 2020 show that K drug combined with platinum-containing chemotherapy can reduce the mortality risk of the overall population and esophageal squamous cell carcinoma by 27% and 28% respectively2.
KEYNOTE-590: Comparison of partial data between the overall population and the Chinese subgroup population 1, 2 Compared with the overall population, the physical condition of the Chinese subgroup population enrolled in KEYNOTE-590 is worse.
Patients with an ECOG PS score of 1 accounted for 81.
1%, which is less than The proportion of the overall population (59.
8%) is 21.
3% higher1.But even so, the ORR (37.
3%) of the first-line treatment of Chinese patients with advanced esophageal cancer by K drug combined with chemotherapy has increased by 17.
3% compared with the chemotherapy group (20.
0%), which is nearly doubled! And it is no less than the ORR difference of the overall population (15.
7%), and it can still bring better OS benefit trends.
It is worth noting that KEYNOTE-590 is not the first phase III clinical study to show the "preference" of drug K for the Chinese population with esophageal cancer.
At the 2019 ESMO conference, K-drug single-agent treatment of recurrent locally advanced or metastatic esophageal cancer that has received first-line systemic treatment in the past, the analysis results of the Chinese population subgroup of the global multi-center phase III clinical study KEYNOTE-181 showed that K Drug treatment of the Chinese population reduces the risk of death by 45%3, which is three times the reduction of the risk of death in the overall population4.
KEYNOTE-181: OS3, 4 of the overall population (A) and the Chinese subgroup (B) Based on the Chinese population data results of the KEYNOTE-181 study, the National Medical Products Administration (NMPA) of my country has approved the K drug in June 2020 It is used for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed the previous first-line systemic therapy.
After being approved by the FDA in March this year, Drug K has become the only PD-1 inhibitor in the world that has been approved in combination with chemotherapy for the first-line treatment of the entire population of advanced esophageal cancer (regardless of PD-L1 level), and this indication is also available in 2020.
It was submitted to my country's NMPA in November 2011 and was accepted, and it is expected to be approved this year.
The early symptoms of esophageal cancer patients in my country are not obvious, and about 70% of newly diagnosed patients have developed locally advanced; and in operable esophageal cancer, 50%-60% of patients will relapse or have distant metastasis after surgery, and metastatic The treatment of esophageal cancer has developed slowly in the past few decades.
The first-line treatment is still mainly 5-FU, or paclitaxel combined with platinum-containing chemotherapy, which is inefficient and brings limited survival benefits.
KEYNOTE-590 Chinese population data results prove that K drug combined with first-line treatment can improve the overall survival of patients with advanced esophageal cancer in my country and greatly reduce the risk of death.
It is expected that the first-line treatment indication will be officially approved in China as soon as possible to benefit Chinese patients with esophageal cancer.References: 1.
www.
asco.
org2.
Ken Kato et al.
, Pembrolizumab Plus Chemotherapy Versus Chemotherapy as First-Line Therapy in Patients with Advanced Esophageal Cancer: The Phase 3 KEYNOTE-590 Study, ESMO 2020, LBA 83.
Chen J et al.
, Pembrolizumab versus Chemotherapy in Patients with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus as Second-line Therapy: Analysis of the Chinese Sub-group in KEYNOTE-181, Abstract, 2019 ESMO4.
Shah MA et al.
, Pembrolizumab versus Chemotherapy in Advanced Esophageal Cancer: Phase 3 KEYNOTE-181 Study, 2019 ASCO
ASCO official website announced the results of KEYNOTE-590 Chinese population data analysis 1KEYNOTE-590 is a global multi-center, randomized, double-blind, phase III clinical study aimed at evaluating pembrolizumab (commonly known as “K drug” in China) combined with cis Platinum and 5-fluorouracil (5-FU), compared with the efficacy and safety of cisplatin and 5-FU in the first-line treatment of unresectable locally advanced or metastatic esophageal cancer.
The interim analysis results of the study with a median follow-up of 10.
8 months caused a sensation after the official publication of the European Society of Internal Medicine (ESMO) conference in 2020 for the first time, and became the first to show that the first-line treatment of advanced esophageal cancer with immune combined chemotherapy is significantly better than chemotherapy.
III Phase clinical research.
The results of the data analysis of the Chinese subgroups released this time show that among the 107 cases of Chinese esophageal cancer (esophageal squamous cell carcinoma accounted for 98.
1%), compared with the control group, the K drug combined with platinum-containing chemotherapy can reduce the first-line treatment by 49% Risk of death (HR, 0.
51; 95% CI, 0.
32-0.
81)1.
The results of the KEYNOTE-590 overall population data analysis published by ESMO in 2020 show that K drug combined with platinum-containing chemotherapy can reduce the mortality risk of the overall population and esophageal squamous cell carcinoma by 27% and 28% respectively2.
KEYNOTE-590: Comparison of partial data between the overall population and the Chinese subgroup population 1, 2 Compared with the overall population, the physical condition of the Chinese subgroup population enrolled in KEYNOTE-590 is worse.
Patients with an ECOG PS score of 1 accounted for 81.
1%, which is less than The proportion of the overall population (59.
8%) is 21.
3% higher1.But even so, the ORR (37.
3%) of the first-line treatment of Chinese patients with advanced esophageal cancer by K drug combined with chemotherapy has increased by 17.
3% compared with the chemotherapy group (20.
0%), which is nearly doubled! And it is no less than the ORR difference of the overall population (15.
7%), and it can still bring better OS benefit trends.
It is worth noting that KEYNOTE-590 is not the first phase III clinical study to show the "preference" of drug K for the Chinese population with esophageal cancer.
At the 2019 ESMO conference, K-drug single-agent treatment of recurrent locally advanced or metastatic esophageal cancer that has received first-line systemic treatment in the past, the analysis results of the Chinese population subgroup of the global multi-center phase III clinical study KEYNOTE-181 showed that K Drug treatment of the Chinese population reduces the risk of death by 45%3, which is three times the reduction of the risk of death in the overall population4.
KEYNOTE-181: OS3, 4 of the overall population (A) and the Chinese subgroup (B) Based on the Chinese population data results of the KEYNOTE-181 study, the National Medical Products Administration (NMPA) of my country has approved the K drug in June 2020 It is used for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed the previous first-line systemic therapy.
After being approved by the FDA in March this year, Drug K has become the only PD-1 inhibitor in the world that has been approved in combination with chemotherapy for the first-line treatment of the entire population of advanced esophageal cancer (regardless of PD-L1 level), and this indication is also available in 2020.
It was submitted to my country's NMPA in November 2011 and was accepted, and it is expected to be approved this year.
The early symptoms of esophageal cancer patients in my country are not obvious, and about 70% of newly diagnosed patients have developed locally advanced; and in operable esophageal cancer, 50%-60% of patients will relapse or have distant metastasis after surgery, and metastatic The treatment of esophageal cancer has developed slowly in the past few decades.
The first-line treatment is still mainly 5-FU, or paclitaxel combined with platinum-containing chemotherapy, which is inefficient and brings limited survival benefits.
KEYNOTE-590 Chinese population data results prove that K drug combined with first-line treatment can improve the overall survival of patients with advanced esophageal cancer in my country and greatly reduce the risk of death.
It is expected that the first-line treatment indication will be officially approved in China as soon as possible to benefit Chinese patients with esophageal cancer.References: 1.
www.
asco.
org2.
Ken Kato et al.
, Pembrolizumab Plus Chemotherapy Versus Chemotherapy as First-Line Therapy in Patients with Advanced Esophageal Cancer: The Phase 3 KEYNOTE-590 Study, ESMO 2020, LBA 83.
Chen J et al.
, Pembrolizumab versus Chemotherapy in Patients with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus as Second-line Therapy: Analysis of the Chinese Sub-group in KEYNOTE-181, Abstract, 2019 ESMO4.
Shah MA et al.
, Pembrolizumab versus Chemotherapy in Advanced Esophageal Cancer: Phase 3 KEYNOTE-181 Study, 2019 ASCO
