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On March 22, 2021, the U.
S.
Food and Drug Administration (FDA) approved pembrolizumab combined with chemotherapy (cisplatin + 5-fluorouracil [5-FU]) for metastatic or locally advanced esophageal cancer or esophageal gastric junction cancer (GEJ) First-line treatment of patients.
The approval is mainly based on the pivotal phase III KEYNOTE-590 trial, which met the primary endpoints of overall survival (OS) and progression-free survival (PFS).
Compared with the current standard first-line chemotherapy regimen, the pembrolizumab combination treatment regimen has shown statistically significant and clinically significant improvements in OS and PFS in the overall study population and the treatment of each study subgroup.
The treatment of metastatic esophageal cancer has developed very slowly in the past few decades.
The first-line treatment is still based on 5-FU or paclitaxel combined with platinum-containing chemotherapy.
The effective rate is low, and the median OS is less than one year.
With the continuous breakthrough of immunotherapy in various cancer types, the treatment of esophageal cancer in recent years has also opened a new era of immunotherapy.
KEYNOTE-590 is a global multicenter, randomized, double-blind, controlled phase III clinical study, enrolling a total of 749 patients with unresectable locally advanced or metastatic esophageal cancer who have not received drug treatment, including esophageal adenocarcinoma and esophageal squamous cell carcinoma Stem cell carcinoma (ESCC), or Siewert type I adenocarcinoma of the gastroesophageal junction.
These patients were randomized to receive pembrolizumab (200 mg Q3W) in combination with cisplatin and 5-FU or placebo in combination with cisplatin and 5-FU in a 1:1 ratio.
Randomly stratified according to pathological type (adenocarcinoma or esophageal squamous cell carcinoma population), region (Asian or non-Asian population) and ECOG score.
KEYNOTE-590 Study Design The primary endpoints of the study were OS and PFS in the intention-to-treat (ITT) population, ESCC, and ESCC with PD-L1 composite positive score (CPS) ≥10 and ITT population.
Secondary endpoints include objective response rate (ORR), duration of response (DOR), and safety and tolerability.
The results of the KEYNOTE-590 study showed that the OS and PFS benefits of pembrolizumab combined with chemotherapy in the first-line treatment of ITT population (regardless of PD-L1 expression) were significantly better than platinum-containing chemotherapy regimens: median OS was 12.
4 Month, significantly longer than the chemotherapy group (9.
8 months) (HR=0.
73, 95% 0.
62~0.
86; P<0.
0001), and the risk of death was reduced by 27%; the 12-month OS was 51%, compared with the chemotherapy group (39%) Increased by 12%; median PFS was 6.
3 months, which was significantly longer than the chemotherapy group (5.
8 months) (HR=0.
65, 95% CI 0.
55~0.
76; P<0.
0001), and the risk of disease progression or death was reduced by 35%; ORR It reached 45.
0%, an increase of 54% (P<0.
0001) compared with the chemotherapy group (29.
3%).
At 24 months, the number of tumors in continuous remission was three times that of the chemotherapy group.
In addition, the OS benefit of pembrolizumab combined with chemotherapy in ESCC and ITT populations with PD-L1 CPS ≥ 10 is more obvious: in the ESCC population with PD-L1 CPS ≥ 10, pembrolizumab in combination with chemotherapy group The OS reached 13.
9 months, which was significantly longer than the 8.
8 months in the chemotherapy group (HR=0.
57, 95% CI 0.
43~0.
75; P<0.
0001), and the risk of death was reduced by 43%, which was better than 28% in the ESCC population; in PD- In the ITT population with L1 CPS ≥ 10, the median OS of the pembrolizumab combined with chemotherapy group reached 13.
5 months, which was significantly longer than that of the chemotherapy group (9.
4 months) (HR=0.
62, 95% CI 0.
49~0.
78; P< 0.
0001), the risk of death was reduced by 38%, better than the 27% of the ITT population. References: 1.
Kato K, Sun JM, Shah MA, et al.
Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: the phase 3 KEYNOTE-590 study.
Ann Oncol.
2020;31(suppl 4):S1192-S1193.
doi:10.
1016/j.
annonc.
2020.
08.
2298
S.
Food and Drug Administration (FDA) approved pembrolizumab combined with chemotherapy (cisplatin + 5-fluorouracil [5-FU]) for metastatic or locally advanced esophageal cancer or esophageal gastric junction cancer (GEJ) First-line treatment of patients.
The approval is mainly based on the pivotal phase III KEYNOTE-590 trial, which met the primary endpoints of overall survival (OS) and progression-free survival (PFS).
Compared with the current standard first-line chemotherapy regimen, the pembrolizumab combination treatment regimen has shown statistically significant and clinically significant improvements in OS and PFS in the overall study population and the treatment of each study subgroup.
The treatment of metastatic esophageal cancer has developed very slowly in the past few decades.
The first-line treatment is still based on 5-FU or paclitaxel combined with platinum-containing chemotherapy.
The effective rate is low, and the median OS is less than one year.
With the continuous breakthrough of immunotherapy in various cancer types, the treatment of esophageal cancer in recent years has also opened a new era of immunotherapy.
KEYNOTE-590 is a global multicenter, randomized, double-blind, controlled phase III clinical study, enrolling a total of 749 patients with unresectable locally advanced or metastatic esophageal cancer who have not received drug treatment, including esophageal adenocarcinoma and esophageal squamous cell carcinoma Stem cell carcinoma (ESCC), or Siewert type I adenocarcinoma of the gastroesophageal junction.
These patients were randomized to receive pembrolizumab (200 mg Q3W) in combination with cisplatin and 5-FU or placebo in combination with cisplatin and 5-FU in a 1:1 ratio.
Randomly stratified according to pathological type (adenocarcinoma or esophageal squamous cell carcinoma population), region (Asian or non-Asian population) and ECOG score.
KEYNOTE-590 Study Design The primary endpoints of the study were OS and PFS in the intention-to-treat (ITT) population, ESCC, and ESCC with PD-L1 composite positive score (CPS) ≥10 and ITT population.
Secondary endpoints include objective response rate (ORR), duration of response (DOR), and safety and tolerability.
The results of the KEYNOTE-590 study showed that the OS and PFS benefits of pembrolizumab combined with chemotherapy in the first-line treatment of ITT population (regardless of PD-L1 expression) were significantly better than platinum-containing chemotherapy regimens: median OS was 12.
4 Month, significantly longer than the chemotherapy group (9.
8 months) (HR=0.
73, 95% 0.
62~0.
86; P<0.
0001), and the risk of death was reduced by 27%; the 12-month OS was 51%, compared with the chemotherapy group (39%) Increased by 12%; median PFS was 6.
3 months, which was significantly longer than the chemotherapy group (5.
8 months) (HR=0.
65, 95% CI 0.
55~0.
76; P<0.
0001), and the risk of disease progression or death was reduced by 35%; ORR It reached 45.
0%, an increase of 54% (P<0.
0001) compared with the chemotherapy group (29.
3%).
At 24 months, the number of tumors in continuous remission was three times that of the chemotherapy group.
In addition, the OS benefit of pembrolizumab combined with chemotherapy in ESCC and ITT populations with PD-L1 CPS ≥ 10 is more obvious: in the ESCC population with PD-L1 CPS ≥ 10, pembrolizumab in combination with chemotherapy group The OS reached 13.
9 months, which was significantly longer than the 8.
8 months in the chemotherapy group (HR=0.
57, 95% CI 0.
43~0.
75; P<0.
0001), and the risk of death was reduced by 43%, which was better than 28% in the ESCC population; in PD- In the ITT population with L1 CPS ≥ 10, the median OS of the pembrolizumab combined with chemotherapy group reached 13.
5 months, which was significantly longer than that of the chemotherapy group (9.
4 months) (HR=0.
62, 95% CI 0.
49~0.
78; P< 0.
0001), the risk of death was reduced by 38%, better than the 27% of the ITT population. References: 1.
Kato K, Sun JM, Shah MA, et al.
Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: the phase 3 KEYNOTE-590 study.
Ann Oncol.
2020;31(suppl 4):S1192-S1193.
doi:10.
1016/j.
annonc.
2020.
08.
2298
