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Preface As the world's first PD-1 inhibitor approved for marketing, the clinical research carried out by nivolumab (Odivo, drug O) has always been a vane for the development of immuno-oncology treatments.
Recently, the only PD-1 inhibitor directly involved in the development of Nobel Prize winner Dr.
Shuyou Ben, released two major research results in the field of upper gastrointestinal tumors: preliminary results of the Phase III clinical study CheckMate-648 Shows that nivolumab combined with ipilimumab (Immune Gemini) and nivolumab combined with chemotherapy can bring significant survival gains for patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) beneficial.
The detailed results of the Chinese subgroup of the Phase III clinical study CheckMate-649 showed that compared with chemotherapy alone, nivolumab combined with chemotherapy for the first-line treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer has achieved clinical significance The overall survival (OS) and progression-free survival (PFS) benefits, and a higher objective response rate (ORR), this result is consistent with the global overall situation of advanced gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma in the study The results of the population are consistent; based on the results of the CheckMate-649 and CheckMate-648 studies, nivolumab has become the world's first and currently the only proven first-line treatment of upper gastrointestinal malignancies of various histological types and tumor sites (Including stomach, gastroesophagus, esophagus) PD-1/L1 inhibitors with significant survival benefit.
CheckMate-649 is the largest global phase III clinical study carried out in the field of gastric cancer so far.
As a result, nivolumab combined with chemotherapy has become the first-line treatment for HER2-negative gastric cancer and gastroesophageal junction cancer in the first-line treatment of HER2-negative gastric cancer and gastroesophageal junction cancer for more than ten years.
Treatment options with significant survival benefits.So, is the first-line treatment effect and safety of this golden combination for patients with advanced gastric cancer in China consistent with the results of the entire population? Yesterday, CheckMate-649 China subgroup data handed over a surprising answer-OS and PFS survival benefit curve is amazing! ORR is higher! In a clinical study of immunotherapy for gastric cancer and gastroesophageal junction cancer covering patients in mainland China, the CheckMate-649 study is the first and currently the only first-line treatment phase III study with positive results, and a total of 208 previously untreated and inoperable patients were included Of HER2-negative Chinese patients with advanced or metastatic gastric cancer or gastroesophageal junction cancer.
The results show that in the Chinese population: Compared with chemotherapy alone, nivolumab combined with chemotherapy for first-line treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer has achieved clinically significant OS and PFS benefits.
And higher ORR; regardless of whether PD-L1 expression is positive and the combined positive score (CPS) ≥ 5, CPS ≥ 1, or all random populations, OS and PFS benefits are observed; the above subgroup analysis results are consistent with CheckMate- The results of advanced gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma in the 649 study are consistent across the entire population.
In patients with PD-L1 positive and CPS ≥5: OS and PFS in the nivolumab + chemotherapy group were 1.
5 times and nearly twice that of the chemotherapy group alone: median OS in the nivolumab + chemotherapy group 15.
5 months (95% CI: 11.
9-25.
5), compared with 9.
6 months (95% CI: 8.
0-12.
1) for the control group chemotherapy alone (HR: 0.
54; 95% CI: 0.
36-0.
79); The median PFS of the anti+chemotherapy group was 8.
5 months (95% CI: 5.
9-12.
4), and the chemotherapy group alone was 4.
3 months (95% CI: 4.
1-6.
5) (HR: 0.
52; 95% CI: 0.
34-0.
77 ). The ORR of the nivolumab+chemotherapy group was higher than that of the chemotherapy group alone: the ORR of the nivolumumab+chemotherapy group was 68% (95% CI: 56-79), and the ORR of the chemotherapy alone group was 48% (95% CI : 36-60) Professor Lin Shen, the main researcher of CheckMate-649 in China and the deputy dean of Peking University Cancer Hospital, said: "The incidence and mortality of gastric cancer in China account for 44% and 49% of the global rate, respectively1,2, and approximately 80% of patients are already in advanced stage 3 at the time of diagnosis.
First-line treatment of gastric cancer is a key factor in determining the survival benefit and subsequent treatment of patients.
However, in the past, first-line standard chemotherapy can bring very limited survival benefits to patients, and clinical innovation is urgently needed.
Treatment options.
The clinical needs of Chinese patients are one of the biggest driving forces for the development of advanced gastric cancer treatments in the world.
The Chinese subgroup data of the CheckMate-649 study strengthens our confidence in promoting the continuous development of gastric cancer and gastroesophageal junction cancer immunotherapy, and It is expected to completely revolutionize the pattern of first-line treatment for advanced gastric cancer and gastroesophageal junction cancer in
China .
” Professor Xu Ruihua, a Chinese researcher at CheckMate-649 and dean of Sun Yat-sen University Cancer Center, pointed out: “Gastric cancer is one of the most important public health issues in China.
Accumulating Chinese data, reflecting Chinese voices, and exploring innovative treatments suitable for Chinese patients are important aspects of clinical research.
The Chinese subgroup data of the CheckMate-649 study for the first time clarified that immune checkpoint inhibitors combined with chemotherapy can help Chinese gastric cancer and gastroesophagus First-line patients with junctional cancer bring significant survival benefits, and this conclusion is based on the considerable scale of the Chinese population.
It provides abundant evidence-based medical evidence for the clinical treatment and academic research of gastric cancer in China, and is expected to become a diagnosis and treatment in China in the future An important reference for the development of guidelines to promote the development of the overall level of diagnosis and treatment of gastric cancer in China. "In PD-L1 positive patients with CPS ≥ 1 and all randomized populations, nivolumab + chemotherapy also showed clinically significant OS benefits: in patients with CPS ≥ 1, nivolumab + chemotherapy The median OS (HR: 0.
62; 95% CI: 0.
43-0.
87) in the group was 14.
3 months (95% CI: 11.
5–17.
5), and in the chemotherapy group alone was 9.
9 months (95% CI: 8.
1–12.
1); In all randomized populations, the median OS (HR: 0.
61; 95% CI: 0.
44-0.
85) in the nivolumab+chemotherapy group was 14.
3 months (95% CI: 11.
5–17.
5), compared with 10.
3 in the chemotherapy group alone Months (95% CI: 8.
1–12.
1).
In this study, the safety characteristics of nivolumab + chemotherapy are consistent with the known safety characteristics of nivolumab and chemotherapy, and no new safety features have been observed.
sexual signals
and patient safety China subgroups overall consistent with the global population.
Myers Squibb vice president of global R & D Bristol, Chinese R & D head Dr.
James Cai said: "in full consideration China cancer in a high incidence of the premise, CheckMate-649 study included It has selected large-scale Chinese patients who are representative of first-line gastric cancer, and adopted a strategy that is highly compatible with the current clinical practice of gastric cancer in China, which is a milestone in the clinical research and treatment of gastric cancer in China.
Among the first-line treatments for HER2-negative gastric cancer and gastroesophageal junction cancer, Odivo combined chemotherapy is the first and currently the only treatment program that has been proven by phase III clinical trials to surpass chemotherapy and bring significant survival benefits to patients.
.
We hope to bring this breakthrough clinically valuable treatment option to more Chinese patients as soon as possible, and solve their urgent and unmet need for treatment.
"One picture to see the data: compiled from 2021 AACR POSTER CT1844 References: [1] WHO, Globocan 2020 World.
Available from <https://gco.
iarc.
fr/today/data/factsheets/populations/900-world- fact-sheets.
pdf>[2] WHO, Globocan 2020 China.
Available from <https://gco.
iarc.
fr/today/data/factsheets/populations/160-china-fact-sheets.
pdf>[3] Lei Y.
, et al.
Incidence and mortality of stomach cancer in China, 2014 [J].
Chinese Journal of Cancer Research,2018,30(03):291-298.
[4]Shen et al.
2021, NIVO + chemo vs chemo in 1L GC, GEJC, EAC- Chinese subgroup, AACR 2021.
Poster.
Recently, the only PD-1 inhibitor directly involved in the development of Nobel Prize winner Dr.
Shuyou Ben, released two major research results in the field of upper gastrointestinal tumors: preliminary results of the Phase III clinical study CheckMate-648 Shows that nivolumab combined with ipilimumab (Immune Gemini) and nivolumab combined with chemotherapy can bring significant survival gains for patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) beneficial.
The detailed results of the Chinese subgroup of the Phase III clinical study CheckMate-649 showed that compared with chemotherapy alone, nivolumab combined with chemotherapy for the first-line treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer has achieved clinical significance The overall survival (OS) and progression-free survival (PFS) benefits, and a higher objective response rate (ORR), this result is consistent with the global overall situation of advanced gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma in the study The results of the population are consistent; based on the results of the CheckMate-649 and CheckMate-648 studies, nivolumab has become the world's first and currently the only proven first-line treatment of upper gastrointestinal malignancies of various histological types and tumor sites (Including stomach, gastroesophagus, esophagus) PD-1/L1 inhibitors with significant survival benefit.
CheckMate-649 is the largest global phase III clinical study carried out in the field of gastric cancer so far.
As a result, nivolumab combined with chemotherapy has become the first-line treatment for HER2-negative gastric cancer and gastroesophageal junction cancer in the first-line treatment of HER2-negative gastric cancer and gastroesophageal junction cancer for more than ten years.
Treatment options with significant survival benefits.So, is the first-line treatment effect and safety of this golden combination for patients with advanced gastric cancer in China consistent with the results of the entire population? Yesterday, CheckMate-649 China subgroup data handed over a surprising answer-OS and PFS survival benefit curve is amazing! ORR is higher! In a clinical study of immunotherapy for gastric cancer and gastroesophageal junction cancer covering patients in mainland China, the CheckMate-649 study is the first and currently the only first-line treatment phase III study with positive results, and a total of 208 previously untreated and inoperable patients were included Of HER2-negative Chinese patients with advanced or metastatic gastric cancer or gastroesophageal junction cancer.
The results show that in the Chinese population: Compared with chemotherapy alone, nivolumab combined with chemotherapy for first-line treatment of unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer has achieved clinically significant OS and PFS benefits.
And higher ORR; regardless of whether PD-L1 expression is positive and the combined positive score (CPS) ≥ 5, CPS ≥ 1, or all random populations, OS and PFS benefits are observed; the above subgroup analysis results are consistent with CheckMate- The results of advanced gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma in the 649 study are consistent across the entire population.
In patients with PD-L1 positive and CPS ≥5: OS and PFS in the nivolumab + chemotherapy group were 1.
5 times and nearly twice that of the chemotherapy group alone: median OS in the nivolumab + chemotherapy group 15.
5 months (95% CI: 11.
9-25.
5), compared with 9.
6 months (95% CI: 8.
0-12.
1) for the control group chemotherapy alone (HR: 0.
54; 95% CI: 0.
36-0.
79); The median PFS of the anti+chemotherapy group was 8.
5 months (95% CI: 5.
9-12.
4), and the chemotherapy group alone was 4.
3 months (95% CI: 4.
1-6.
5) (HR: 0.
52; 95% CI: 0.
34-0.
77 ). The ORR of the nivolumab+chemotherapy group was higher than that of the chemotherapy group alone: the ORR of the nivolumumab+chemotherapy group was 68% (95% CI: 56-79), and the ORR of the chemotherapy alone group was 48% (95% CI : 36-60) Professor Lin Shen, the main researcher of CheckMate-649 in China and the deputy dean of Peking University Cancer Hospital, said: "The incidence and mortality of gastric cancer in China account for 44% and 49% of the global rate, respectively1,2, and approximately 80% of patients are already in advanced stage 3 at the time of diagnosis.
First-line treatment of gastric cancer is a key factor in determining the survival benefit and subsequent treatment of patients.
However, in the past, first-line standard chemotherapy can bring very limited survival benefits to patients, and clinical innovation is urgently needed.
Treatment options.
The clinical needs of Chinese patients are one of the biggest driving forces for the development of advanced gastric cancer treatments in the world.
The Chinese subgroup data of the CheckMate-649 study strengthens our confidence in promoting the continuous development of gastric cancer and gastroesophageal junction cancer immunotherapy, and It is expected to completely revolutionize the pattern of first-line treatment for advanced gastric cancer and gastroesophageal junction cancer in
China .
” Professor Xu Ruihua, a Chinese researcher at CheckMate-649 and dean of Sun Yat-sen University Cancer Center, pointed out: “Gastric cancer is one of the most important public health issues in China.
Accumulating Chinese data, reflecting Chinese voices, and exploring innovative treatments suitable for Chinese patients are important aspects of clinical research.
The Chinese subgroup data of the CheckMate-649 study for the first time clarified that immune checkpoint inhibitors combined with chemotherapy can help Chinese gastric cancer and gastroesophagus First-line patients with junctional cancer bring significant survival benefits, and this conclusion is based on the considerable scale of the Chinese population.
It provides abundant evidence-based medical evidence for the clinical treatment and academic research of gastric cancer in China, and is expected to become a diagnosis and treatment in China in the future An important reference for the development of guidelines to promote the development of the overall level of diagnosis and treatment of gastric cancer in China. "In PD-L1 positive patients with CPS ≥ 1 and all randomized populations, nivolumab + chemotherapy also showed clinically significant OS benefits: in patients with CPS ≥ 1, nivolumab + chemotherapy The median OS (HR: 0.
62; 95% CI: 0.
43-0.
87) in the group was 14.
3 months (95% CI: 11.
5–17.
5), and in the chemotherapy group alone was 9.
9 months (95% CI: 8.
1–12.
1); In all randomized populations, the median OS (HR: 0.
61; 95% CI: 0.
44-0.
85) in the nivolumab+chemotherapy group was 14.
3 months (95% CI: 11.
5–17.
5), compared with 10.
3 in the chemotherapy group alone Months (95% CI: 8.
1–12.
1).
In this study, the safety characteristics of nivolumab + chemotherapy are consistent with the known safety characteristics of nivolumab and chemotherapy, and no new safety features have been observed.
sexual signals
and patient safety China subgroups overall consistent with the global population.
Myers Squibb vice president of global R & D Bristol, Chinese R & D head Dr.
James Cai said: "in full consideration China cancer in a high incidence of the premise, CheckMate-649 study included It has selected large-scale Chinese patients who are representative of first-line gastric cancer, and adopted a strategy that is highly compatible with the current clinical practice of gastric cancer in China, which is a milestone in the clinical research and treatment of gastric cancer in China.
Among the first-line treatments for HER2-negative gastric cancer and gastroesophageal junction cancer, Odivo combined chemotherapy is the first and currently the only treatment program that has been proven by phase III clinical trials to surpass chemotherapy and bring significant survival benefits to patients.
.
We hope to bring this breakthrough clinically valuable treatment option to more Chinese patients as soon as possible, and solve their urgent and unmet need for treatment.
"One picture to see the data: compiled from 2021 AACR POSTER CT1844 References: [1] WHO, Globocan 2020 World.
Available from <https://gco.
iarc.
fr/today/data/factsheets/populations/900-world- fact-sheets.
pdf>[2] WHO, Globocan 2020 China.
Available from <https://gco.
iarc.
fr/today/data/factsheets/populations/160-china-fact-sheets.
pdf>[3] Lei Y.
, et al.
Incidence and mortality of stomach cancer in China, 2014 [J].
Chinese Journal of Cancer Research,2018,30(03):291-298.
[4]Shen et al.
2021, NIVO + chemo vs chemo in 1L GC, GEJC, EAC- Chinese subgroup, AACR 2021.
Poster.
