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At the 2021 American Society of Clinical Oncology (ASCO) annual meeting held recently, China's high-incidence esophageal squamous cell carcinoma (ESCC) field ushered in a bumper harvest, and a number of phase III immunotherapy research results gathered
.
Among these studies, the one that has attracted the most attention is the CheckMate-648 study, which has the largest sample size and is the only one selected for the conference as a blockbuster progress (LBA) with delayed public data
.
Judging from the latest data released, many of the highlights and surprises make this honor well-deserved
.
Core Data First Look at CheckMate -648 Study is a Phase III, randomized, global clinical study designed to evaluate the world's first PD-1 inhibitor-Drug O (Nivolumab, Odivo).
Combination immunotherapy, compared with chemotherapy alone (5-fluorouracil + cisplatin) for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma
.
CheckMate -648 is also the first and currently the only phase III clinical study evaluating dual immunity (PD-1 inhibitor + CTLA-4 inhibitor) combined treatment of advanced esophageal squamous cell carcinoma.
A total of 970 previously unidentified patients including Chinese patients were included.
Patients with advanced or metastatic esophageal squamous cell carcinoma who are treated and inoperable
.
The sample size of this study also set a record in the field of immunotherapy for esophageal squamous cell carcinoma
.
The study has previously announced preliminary positive results: Compared with chemotherapy, O drug + chemotherapy (5-fluorouracil + cisplatin), and O drug + CTLA-4 inhibitor ipilimumab (O+Y) first-line treatment Patients with unresectable advanced or metastatic esophageal squamous cell carcinoma have achieved significant OS benefits regardless of PD-L1 expression level
.
OS benefited significantly in all randomized populations, ORR was better than chemotherapy ➤ The overall survival (OS) benefit of O+ chemotherapy group and O+Y group was significantly better than chemotherapy, regardless of PD-L1 expression: median of O+ chemotherapy group OS was 13.
2 months, chemotherapy alone group was 10.
7 months (HR 0.
74, 99.
1% CI: 0.
58-0.
96, p=0.
0021); median OS of O+Y group was 12.
8 months, chemotherapy alone group was 10.
7 months (HR 0.
78, 98.
2% CI: 0.
62-0.
98, p=0.
011)
.
➤ The objective response rate (ORR) of the O+Y and O+ chemotherapy groups was better than that of chemotherapy, suggesting that PD-1 inhibitors combined with CTLA-4 inhibitors are synergistic to improve the effective rate: ORR of O+ chemotherapy and O+Y groups ( 47% and 28% respectively) were significantly better than and not inferior to chemotherapy alone (27%)
.
➤ The duration of remission (DoR) in the O+Y group is more than twice that of chemotherapy.
Once dual immunotherapy is effective, it can bring long-term benefits: The median DoR in the O+Y group can reach 11.
1 months, which is nearly two times the chemotherapy group.
Times (7.
1 months), showing that once O+Y is effective, it can bring long-term benefits to patients
.
The above results show that compared with current standard chemotherapy, O+ chemotherapy and O+Y can bring significant survival benefits for ESCC first-line patients without the restriction of PD-L1 expression, and are expected to become the new standard of treatment for these patients
.
There are also clinical benefits in PD-L1 positive patients, with higher OS and ORR ➤ The OS of the O drug + chemotherapy group is 6 months longer than that of the chemotherapy alone group, and the ORR can reach more than 2.
5 times the chemotherapy group: the median of the O drug + chemotherapy group The OS was 15.
4 months and the chemotherapy alone group was 9.
1 months (HR 0.
54, 99.
5% CI: 0.
37-0.
80, p<0.
0001); the ORR of the O drug + chemotherapy group was 53%, and the chemotherapy alone group was 20%
.
➤ The OS of the O+Y group was 1.
5 times that of the chemotherapy group, and the median time of remission could reach nearly one year, which was more than twice that of chemotherapy: the OS of the O+Y group was 13.
7 months, and the chemotherapy group alone was 9.
1 months (HR 0.
64) ; 98.
6% CI: 0.
46-0.
90, p=0.
001); the median DoR in the O+Y group was up to 11.
8 months, and that in the chemotherapy group alone was 5.
7 months
.
In this study, the safety characteristics of O+chemotherapy/O+Y were consistent with the known safety characteristics, and no new safety signals were observed
.
It is worth mentioning that the incidence of grade 3/4 drug-related adverse events in the O+Y group was 32%, which was lower than the 36% in the chemotherapy group
.
The CheckMate-648 study achieved a milestone in the O+ chemotherapy/O+Y group OS "dual superiority" results
.
The research has not only harvested the first phase III research results of the dual-immune combination in the field of esophageal cancer, but also helped O drug become the only one currently proven to be used in adjuvant treatment of esophageal cancer from postoperative adjuvant treatment to advanced first-line treatment, which can bring significant clinical results.
Benefits of PD-1/PD-L1 inhibitors: ➤ The CheckMate-577 study confirmed that the O drug adjuvant treatment of esophageal cancer (EC) and gastroesophageal junction cancer (GEJ) that have undergone neoadjuvant concurrent radiochemotherapy and surgery Double the patient's disease-free survival (DFS)
.
In May, approved by the FDA, O drug became the world's first and currently the only immune adjuvant therapy for the above-mentioned population
.
➤ In addition to the CheckMate-649 study confirming that O-drug resistance combined with chemotherapy in the first-line treatment of gastric cancer (GC) and gastroesophageal junction cancer (GEJ) can significantly improve patients’ OS and PFS, this "double-benefit" survival benefit also applies It was confirmed in the esophageal adenocarcinoma (EAC) population in the study
.
In addition, based on the two sister studies of CheckMate-648 and CheckMate-649, O-drug has become the world's first and currently the only PD-1/PD-L1 whose first-line treatment of upper gastrointestinal tumors can bring significant OS benefits.
Inhibitors, and include various histological types (squamous cell carcinoma or adenocarcinoma) and tumor sites (stomach, gastroesophageal junction, esophagus)
.
2021 can be regarded as a bumper year for the field of esophageal cancer.
As immunotherapy represented by O drugs and O+Y enters this field in an all-round way, we continue to "conquer the city", and successively obtain important breakthroughs from the auxiliary to the advanced stage.
It is believed that more and more patients with esophageal cancer at different disease stages and different pathological types can usher in more long-term survival hopes
.
Fixed layout The fixed width and height background can be set on the toolbar.
It can be included.
You can perfectly align the background image and text and make your own template.
CheckMate -648 can be seen clearly.
Data source: ASCO conference abstract
.
Among these studies, the one that has attracted the most attention is the CheckMate-648 study, which has the largest sample size and is the only one selected for the conference as a blockbuster progress (LBA) with delayed public data
.
Judging from the latest data released, many of the highlights and surprises make this honor well-deserved
.
Core Data First Look at CheckMate -648 Study is a Phase III, randomized, global clinical study designed to evaluate the world's first PD-1 inhibitor-Drug O (Nivolumab, Odivo).
Combination immunotherapy, compared with chemotherapy alone (5-fluorouracil + cisplatin) for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma
.
CheckMate -648 is also the first and currently the only phase III clinical study evaluating dual immunity (PD-1 inhibitor + CTLA-4 inhibitor) combined treatment of advanced esophageal squamous cell carcinoma.
A total of 970 previously unidentified patients including Chinese patients were included.
Patients with advanced or metastatic esophageal squamous cell carcinoma who are treated and inoperable
.
The sample size of this study also set a record in the field of immunotherapy for esophageal squamous cell carcinoma
.
The study has previously announced preliminary positive results: Compared with chemotherapy, O drug + chemotherapy (5-fluorouracil + cisplatin), and O drug + CTLA-4 inhibitor ipilimumab (O+Y) first-line treatment Patients with unresectable advanced or metastatic esophageal squamous cell carcinoma have achieved significant OS benefits regardless of PD-L1 expression level
.
OS benefited significantly in all randomized populations, ORR was better than chemotherapy ➤ The overall survival (OS) benefit of O+ chemotherapy group and O+Y group was significantly better than chemotherapy, regardless of PD-L1 expression: median of O+ chemotherapy group OS was 13.
2 months, chemotherapy alone group was 10.
7 months (HR 0.
74, 99.
1% CI: 0.
58-0.
96, p=0.
0021); median OS of O+Y group was 12.
8 months, chemotherapy alone group was 10.
7 months (HR 0.
78, 98.
2% CI: 0.
62-0.
98, p=0.
011)
.
➤ The objective response rate (ORR) of the O+Y and O+ chemotherapy groups was better than that of chemotherapy, suggesting that PD-1 inhibitors combined with CTLA-4 inhibitors are synergistic to improve the effective rate: ORR of O+ chemotherapy and O+Y groups ( 47% and 28% respectively) were significantly better than and not inferior to chemotherapy alone (27%)
.
➤ The duration of remission (DoR) in the O+Y group is more than twice that of chemotherapy.
Once dual immunotherapy is effective, it can bring long-term benefits: The median DoR in the O+Y group can reach 11.
1 months, which is nearly two times the chemotherapy group.
Times (7.
1 months), showing that once O+Y is effective, it can bring long-term benefits to patients
.
The above results show that compared with current standard chemotherapy, O+ chemotherapy and O+Y can bring significant survival benefits for ESCC first-line patients without the restriction of PD-L1 expression, and are expected to become the new standard of treatment for these patients
.
There are also clinical benefits in PD-L1 positive patients, with higher OS and ORR ➤ The OS of the O drug + chemotherapy group is 6 months longer than that of the chemotherapy alone group, and the ORR can reach more than 2.
5 times the chemotherapy group: the median of the O drug + chemotherapy group The OS was 15.
4 months and the chemotherapy alone group was 9.
1 months (HR 0.
54, 99.
5% CI: 0.
37-0.
80, p<0.
0001); the ORR of the O drug + chemotherapy group was 53%, and the chemotherapy alone group was 20%
.
➤ The OS of the O+Y group was 1.
5 times that of the chemotherapy group, and the median time of remission could reach nearly one year, which was more than twice that of chemotherapy: the OS of the O+Y group was 13.
7 months, and the chemotherapy group alone was 9.
1 months (HR 0.
64) ; 98.
6% CI: 0.
46-0.
90, p=0.
001); the median DoR in the O+Y group was up to 11.
8 months, and that in the chemotherapy group alone was 5.
7 months
.
In this study, the safety characteristics of O+chemotherapy/O+Y were consistent with the known safety characteristics, and no new safety signals were observed
.
It is worth mentioning that the incidence of grade 3/4 drug-related adverse events in the O+Y group was 32%, which was lower than the 36% in the chemotherapy group
.
The CheckMate-648 study achieved a milestone in the O+ chemotherapy/O+Y group OS "dual superiority" results
.
The research has not only harvested the first phase III research results of the dual-immune combination in the field of esophageal cancer, but also helped O drug become the only one currently proven to be used in adjuvant treatment of esophageal cancer from postoperative adjuvant treatment to advanced first-line treatment, which can bring significant clinical results.
Benefits of PD-1/PD-L1 inhibitors: ➤ The CheckMate-577 study confirmed that the O drug adjuvant treatment of esophageal cancer (EC) and gastroesophageal junction cancer (GEJ) that have undergone neoadjuvant concurrent radiochemotherapy and surgery Double the patient's disease-free survival (DFS)
.
In May, approved by the FDA, O drug became the world's first and currently the only immune adjuvant therapy for the above-mentioned population
.
➤ In addition to the CheckMate-649 study confirming that O-drug resistance combined with chemotherapy in the first-line treatment of gastric cancer (GC) and gastroesophageal junction cancer (GEJ) can significantly improve patients’ OS and PFS, this "double-benefit" survival benefit also applies It was confirmed in the esophageal adenocarcinoma (EAC) population in the study
.
In addition, based on the two sister studies of CheckMate-648 and CheckMate-649, O-drug has become the world's first and currently the only PD-1/PD-L1 whose first-line treatment of upper gastrointestinal tumors can bring significant OS benefits.
Inhibitors, and include various histological types (squamous cell carcinoma or adenocarcinoma) and tumor sites (stomach, gastroesophageal junction, esophagus)
.
2021 can be regarded as a bumper year for the field of esophageal cancer.
As immunotherapy represented by O drugs and O+Y enters this field in an all-round way, we continue to "conquer the city", and successively obtain important breakthroughs from the auxiliary to the advanced stage.
It is believed that more and more patients with esophageal cancer at different disease stages and different pathological types can usher in more long-term survival hopes
.
Fixed layout The fixed width and height background can be set on the toolbar.
It can be included.
You can perfectly align the background image and text and make your own template.
CheckMate -648 can be seen clearly.
Data source: ASCO conference abstract
