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Esophageal cancer (picture source: medindia.
net)
Esophageal cancer (picture source: medindia.net)
net)
News on June 10, 2021 // --Bristol-Myers Squibb (BMS) recently announced the results of its Phase 3 CheckMate-648 trial
.
The trial is evaluating anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, nivolumab) combined with chemotherapy (fluorouracil + cisplatin), Opdivo combined with anti-CTLA-4 therapy (ipilimumab, ipilimumab) ), the efficacy and safety of chemotherapy alone in the treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
.
The primary endpoint of the study include: independent central review blinded (BICR) Evaluation determined tumors expressing overall survival (OS) in patients with PD-L1 in and progression-free survival (PFS), two types Opdivo combination therapy with Compare with chemotherapy
.
Secondary endpoints include: OS and PFS in all randomized patient populations determined by BICR assessment
.
News on June 10, 2021 // --Bristol-Myers Squibb (BMS) recently announced the results of its Phase 3 CheckMate-648 trial.
The trial is evaluating anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, nivolumab) combined with chemotherapy (fluorouracil + cisplatin), Opdivo combined with anti-CTLA-4 therapy (ipilimumab, ipilimumab) ), the efficacy and safety of chemotherapy alone in the treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
.
The primary endpoint of the study include: independent central review blinded (BICR) Evaluation determined tumors expressing overall survival (OS) in patients with PD-L1 in and progression-free survival (PFS), two types Opdivo combination therapy with Compare with chemotherapy
.
Secondary endpoints include: OS and PFS in all randomized patient populations determined by BICR assessment
.
.
The trial is evaluating anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, nivolumab) combined with chemotherapy (fluorouracil + cisplatin), Opdivo combined with anti-CTLA-4 therapy (ipilimumab, ipilimumab) ), the efficacy and safety of chemotherapy alone in the treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
.
The primary endpoint of the study include: independent central review blinded (BICR) Evaluation determined tumors expressing overall survival (OS) in patients with PD-L1 in and progression-free survival (PFS), two types Opdivo combination therapy with Compare with chemotherapy
.
Secondary endpoints include: OS and PFS in all randomized patient populations determined by BICR assessment
.
Tumor
CheckMate-648 is the first global phase 3 study that simultaneously evaluates immunotherapy + chemotherapy and dual immunotherapy for the treatment of advanced ESCC
.
The results showed that in the pre-specified interim analysis, compared with chemotherapy, Opdivo + chemotherapy, Opdivo + Yervoy in the tumor cell PD-L1 expression ≥ 1% of the patient population, in all random patient populations, the OS has statistical significance and Clinically significant improvement
.
It is worth mentioning that Opdivo+Yervoy is the first dual immunotherapy regimen that has a higher survival benefit than chemotherapy in the treatment of esophageal squamous cell carcinoma
.
CheckMate-648 is the first global phase 3 study that simultaneously evaluates immunotherapy + chemotherapy and dual immunotherapy for the treatment of advanced ESCC .
The results showed that in the pre-specified interim analysis, compared with chemotherapy, Opdivo + chemotherapy, Opdivo + Yervoy in the tumor cell PD-L1 expression ≥ 1% of the patient population, in all random patient populations, the OS has statistical significance and Clinically significant improvement
.
It is worth mentioning that Opdivo+Yervoy is the first dual immunotherapy regimen that has a higher survival benefit than chemotherapy in the treatment of esophageal squamous cell carcinoma
.
.
Compared with chemotherapy, Opdivo+chemotherapy, Opdivo+Yervoy in the patient population with tumor cell PD-L1 expression ≥1%, in all random patient populations, make OS have a statistically significant and clinically significant improvement in tumors
The specific data are as follows: (1) Among patients with tumors expressing PD-L1, the median OS of the 1Opdivo+ chemotherapy group was 15.
4 months, and the chemotherapy group was 9.
1 months (HR=0.
54; 99.
5%CI: 0.
37-0.
80, p< 0.
0001); (2) In all randomized patient groups, the median OS of the 1Opdivo+ chemotherapy group was 13.
2 months, and that of the chemotherapy group was 10.
7 months (HR=0.
74; 99.
1%CI: 0.
58-0.
96, p=0.
0021)
.
The specific data are as follows: (1) Among patients with tumors expressing PD-L1, the median OS of the 1Opdivo+ chemotherapy group was 15. 4 months, and the chemotherapy group was 9.
1 months (HR=0.
54; 99.
5%CI: 0.
37-0.
80, p< 0.
0001); (2) In all randomized patient groups, the median OS of the 1Opdivo+ chemotherapy group was 13.
2 months, and that of the chemotherapy group was 10.
7 months (HR=0.
74; 99.
1%CI: 0.
58-0.
96, p=0.
0021)
.
4 months, and the chemotherapy group was 9.
1 months (HR=0.
54; 99.
5%CI: 0.
37-0.
80, p< 0.
0001); (2) In all randomized patient groups, the median OS of the 1Opdivo+ chemotherapy group was 13.
2 months, and that of the chemotherapy group was 10.
7 months (HR=0.
74; 99.
1%CI: 0.
58-0.
96, p=0.
0021)
.
Tumor
According to BICR evaluation, compared with chemotherapy, Opdivo+ chemotherapy regimen made a statistically significant and clinically significant improvement in PFS in patients whose tumors express PD-L1 (median PFS: 6.
9 months vs 4.
4 months; HR=0.
65; 98.
5 %CI: 0.
46-0.
92; p=0.
0023)
.
According to BICR assessment, compared with chemotherapy, Opdivo+ chemotherapy regimen made a statistically significant and clinically significant improvement in PFS in patients whose tumors express PD-L1 (median PFS: 6. 9 months vs 4.
4 months; HR=0.
65; 98.
5 %CI: 0.
46-0.
92; p=0.
0023)
.
9 months vs 4.
4 months; HR=0.
65; 98.
5 %CI: 0.
46-0.
92; p=0.
0023)
.
Tumor
In addition, compared with chemotherapy, the Opdivo+Yervoy regimen also reached the primary and secondary endpoints : in patients whose tumors express PD-L1 (median OS: 13.
7 months vs 9.
1 months; HR=0.
64; 98.
6%CI: 0.
46-0.
90; p=0.
001) and all randomized patient populations (median OS: 12.
8 months vs 10.
7 months; HR=0.
78; 98.
2%CI: 0.
62-0.
98; p=0.
011) both made OS statistically Improving meaning and clinical significance
.
However, the Opdivo+Yervoy regimen did not achieve the primary endpoint of improving PFS in patients whose tumors express PD-L1 (median PFS: 4.
0 months vs 4.
4 months; HR=1.
02; 98.
5%CI: 0.
73-1.
43; p=0.
8958 )
.
Compared with chemotherapy, Opdivo + Yervoy program also reached the primary and secondary endpoints tumor7 months vs 9.
1 months; HR=0.
64; 98.
6%CI: 0.
46-0.
90; p=0.
001) and all randomized patient populations (median OS: 12.
8 months vs 10.
7 months; HR=0.
78; 98.
2%CI: 0.
62-0.
98; p=0.
011) both made OS statistically Improving meaning and clinical significance
.
However, the Opdivo+Yervoy regimen did not achieve the primary endpoint of improving PFS in patients whose tumors express PD-L1 (median PFS: 4.
0 months vs 4.
4 months; HR=1.
02; 98.
5%CI: 0.
73-1.
43; p=0.
8958 )
.
In terms of duration of remission (DoR): (1) Among patients whose tumors express PD-L1, the median DoR of the Opdivo+ chemotherapy group was 8.
4 months, the Opdivo+Yervoy group was 11.
8 months, and the chemotherapy alone group was 5.
7 months; (2) Among all randomized patient groups, the median DoR of the three groups was 8.
2 months, 11.
1 months and 7.
1 months, respectively
.
In terms of duration of remission (DoR): (1) Among patients whose tumors express PD-L1, the median DoR of the Opdivo+ chemotherapy group was 8. 4 months, the Opdivo+Yervoy group was 11.
8 months, and the chemotherapy alone group was 5.
7 months; (2) Among all randomized patient groups, the median DoR of the three groups was 8.
2 months, 11.
1 months and 7.
1 months, respectively
.
4 months, the Opdivo+Yervoy group was 11.
8 months, and the chemotherapy alone group was 5.
7 months; (2) Among all randomized patient groups, the median DoR of the three groups was 8.
2 months, 11.
1 months and 7.
1 months, respectively
.
Tumor
In terms of objective response rate (ORR), Opdivo+ chemotherapy also showed a clinically significant improvement: (1) Among patients whose tumors express PD-L1, the ORR of the Opdivo+ chemotherapy group was 53%, and the ORR of the Opdivo+Yervoy group was 35%.
The ORR of the chemotherapy alone group was 20%; (2) In all randomized patient groups, the ORRs of the three groups were 47%, 28%, and 27%, respectively
.
In this trial, the safety of Opdivo and Opdivo+Yervoy is consistent with the safety previously reported
.
In terms of objective response rate (ORR), Opdivo+ chemotherapy also showed a clinically significant improvement: (1) Among patients whose tumors express PD-L1, the ORR of the Opdivo+ chemotherapy group was 53%, and the ORR of the Opdivo+Yervoy group was 35%. The ORR of the chemotherapy alone group was 20%; (2) In all randomized patient groups, the ORRs of the three groups were 47%, 28%, and 27%, respectively
.
In this trial, the safety of Opdivo and Opdivo+Yervoy is consistent with the safety previously reported
.
The ORR of the chemotherapy alone group was 20%; (2) In all randomized patient groups, the ORRs of the three groups were 47%, 28%, and 27%, respectively
.
In this trial, the safety of Opdivo and Opdivo+Yervoy is consistent with the safety previously reported
.
Tumor
The data of CheckMate-648 test is based on the data of CheckMate-649 test and CheckMate-577 test
.
These data confirm that Opdivo has significant benefits for patients with upper gastrointestinal cancer (gastric cancer, gastroesophageal junction cancer, esophageal cancer)
.
These data confirm that Opdivo has significant benefits for patients with upper gastrointestinal cancer (gastric cancer, gastroesophageal junction cancer, esophageal cancer) .
These data confirm that Opdivo has significant benefits for patients with upper gastrointestinal cancer (gastric cancer, gastroesophageal junction cancer, esophageal cancer)
.
.
Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer death in the world.
There will be approximately 604,000 new cases in 2020 and more than 544,000 deaths
.
The two most common types of esophageal cancer are squamous cell carcinoma (ESCC) and adenocarcinoma, which account for approximately 90% and 10% of all esophageal cancers, respectively, although the histology of esophageal cancer may vary by region
.
The overall burden of ESCC is concentrated in Asia, with cases occurring in 2020 accounting for approximately 80% of global cases
.
Most cases of esophageal cancer are diagnosed at an advanced stage , affecting the daily life of the patient, including their ability to eat
.
ESCC most commonly occurs in the upper and middle parts of the esophagus, while adenocarcinoma starts in the cells of the mucous glands of the esophagus, and most often occurs in the lower part of the esophagus
.
Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer death in the world. There will be approximately 604,000 new cases in 2020 and more than 544,000 deaths
.
The two most common types of esophageal cancer are squamous cell carcinoma (ESCC) and adenocarcinoma, which account for approximately 90% and 10% of all esophageal cancers, respectively, although the histology of esophageal cancer may vary by region
.
The overall burden of ESCC is concentrated in Asia, with cases occurring in 2020 accounting for approximately 80% of global cases
.
Most cases of esophageal cancer are diagnosed at an advanced stage , affecting the daily life of the patient, including their ability to eat
.
ESCC most commonly occurs in the upper and middle parts of the esophagus, while adenocarcinoma starts in the cells of the mucous glands of the esophagus, and most often occurs in the lower part of the esophagus
.
There will be approximately 604,000 new cases in 2020 and more than 544,000 deaths
.
The two most common types of esophageal cancer are squamous cell carcinoma (ESCC) and adenocarcinoma, which account for approximately 90% and 10% of all esophageal cancers, respectively, although the histology of esophageal cancer may vary by region
.
The overall burden of ESCC is concentrated in Asia, with cases occurring in 2020 accounting for approximately 80% of global cases
.
Most cases of esophageal cancer are diagnosed at an advanced stage , affecting the daily life of the patient, including their ability to eat
.
ESCC most commonly occurs in the upper and middle parts of the esophagus, while adenocarcinoma starts in the cells of the mucous glands of the esophagus, and most often occurs in the lower part of the esophagus
.
diagnosis
Opdivo belongs to PD-(L)1 tumor immunotherapy, which aims to use the body's own immune system to fight cancer, block the PD-1/PD-L1 signaling pathway to kill cancer cells, and has the potential to treat many types of tumors
.
So far, Opdivo has been approved for multiple cancer indications
.
Opdivo belongs to PD-(L)1 tumor immunotherapy, which aims to use the body's own immune system to fight cancer, block the PD-1/PD-L1 signaling pathway to kill cancer cells, and has the potential to treat many types of tumors .
So far, Opdivo has been approved for multiple cancer indications
.
.
So far, Opdivo has been approved for multiple cancer indications
.
Tumor
In terms of esophageal cancer, Opdivo has been approved for 3 treatment indications, specifically: (1) For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after receiving fluoropyrimidine and platinum chemotherapy Regardless of the expression level of PD-L1; (2) for adjuvant treatment of adult patients with esophagus or gastroesophageal junction (GEJ) cancer who have received neoadjuvant chemotherapy and radiotherapy (CRT) and residual pathological disease after complete resection; (3) combined Combination chemotherapy with fluoropyrimidine and platinum is the first-line treatment for adult patients with advanced or metastatic gastric cancer (GC), gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma (EAC), regardless of PD-L1 expression status
.
In terms of esophageal cancer, Opdivo has been approved for 3 treatment indications, specifically: (1) For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after receiving fluoropyrimidine and platinum chemotherapy Regardless of the expression level of PD-L1; (2) for adjuvant treatment of adult patients with esophagus or gastroesophageal junction (GEJ) cancer who have received neoadjuvant chemotherapy and radiotherapy (CRT) and residual pathological disease after complete resection; (3) combined Combination chemotherapy with fluoropyrimidine and platinum is the first-line treatment for adult patients with advanced or metastatic gastric cancer (GC), gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma (EAC), regardless of PD-L1 expression status .
.
In China, Opdivo was approved for listing in June 2018, becoming the first approved immuno- oncology (IO) therapeutic drug in the Chinese market
.
Up to now, Opdivo has been approved by the National Medical Products Administration (NMPA) for 3 therapeutic indications: (1) non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN); (3) stomach or gastroesophagus Junction adenocarcinoma
.
()
In China, Opdivo was approved for listing in June 2018, becoming the first approved immuno- oncology (IO) therapeutic drug in the Chinese market .
Up to now, Opdivo has been approved by the National Medical Products Administration (NMPA) for 3 therapeutic indications: (1) non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN); (3) stomach or gastroesophagus Junction adenocarcinoma
.
()
.
Up to now, Opdivo has been approved by the National Medical Products Administration (NMPA) for 3 therapeutic indications: (1) non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN); (3) stomach or gastroesophagus Junction adenocarcinoma
.
() Tumor
Original source: Bristol Myers Squibb Presents Data from CheckMate -648 Showing Opdivo plus Chemotherapy and Opdivo plus Yervoy Significantly Improved Overall Survival Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Original Source: Bristol Myers Squibb Presents Data from CheckMate -648 Showing Opdivo plus Chemotherapy and Opdivo plus Yervoy Significantly Improved Overall Survival Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma Bristol Myers Squibb Presents Data from CheckMate Chemotherapy and Opdivo plus Opdivo plus Yervoy Significantly Improved Overall Survival Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma 
