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*Only for medical professionals to read for reference.
In 2020, at the annual meeting of the European Society of Medical Oncology (ESMO), the results of a clinical study called CheckMate-649 confirmed that nivolumab (Odivo, O drug) combined with chemotherapy , Compared with chemotherapy alone, used in the first-line treatment of gastric cancer and esophageal cancer, it can significantly improve overall survival (OS) and disease-free survival (PFS).
In 2021, according to the latest agenda of the American Association for Cancer Research (AACR) annual meeting, the largest randomized controlled, global phase III clinical study CheckMate-649 data from the Chinese subgroup of the CheckMate-649 study in the field of gastric cancer and esophageal adenocarcinoma will soon be available.
It will be released on AACR on April 10 (this Saturday).
For a long time, chemotherapy has been the first-line standard treatment for patients with advanced HER2-negative gastric or gastroesophageal junction cancer, but the survival benefit of newly treated patients is usually less than one year after chemotherapy alone.
For more than ten years, the academic community has spared no effort to explore more effective and innovative therapies, but it has never been able to do so.
Even after tumor therapy has entered the immune era, multiple PD-1/PD-L1 inhibitor-based therapies have all come back.
Does immunotherapy have clinical value in the first-line treatment of advanced or metastatic gastric cancer? This unresolved question was finally confirmed by CheckMate-649 research on the dual superiority results of OS and PFS until August last year.
The results showed that nivolumab combined with chemotherapy for the first-line treatment of advanced gastric cancer has an OS of 14.
4 months and a PFS of 7.
7 months in patients with CPS ≥ 5, which are significantly better than chemotherapy alone (11.
1 months; 6.
0 cases) Months); At the same time, OS benefit was also observed in patients with CPS ≥ 1 and all randomized patients.
This is the first major breakthrough in the first-line treatment of HER2-negative advanced gastric cancer in more than ten years.
It eliminates clinical controversy on the immunotherapy of gastric cancer and confirms the value of immune combined chemotherapy in the first-line treatment of gastric cancer. Based on the results of this study, the National Comprehensive Cancer Network (NCCN) 2021 latest gastric cancer guidelines added a recommendation for nivolumab combined with chemotherapy for the treatment of inoperable locally advanced, recurrent or metastatic HER2-negative gastric cancer.
So, is the first-line treatment effect and safety of nivolumab combined with chemotherapy for Chinese patients with metastatic gastric cancer and gastroesophageal junction cancer consistent with the results of the entire population? On the eve of the release of the Chinese subgroup data of the CheckMate-649 study, let’s review the research design and overall population results of this study: The high-standard study design CheckMate-649 is the largest scale of development in the field of gastric cancer and esophageal adenocarcinoma so far.
The global phase III clinical study.
The overall study included a total of 2031 patients from 176 research centers in many countries and regions around the world (among them, the Chinese population accounted for 13.
4%).
The large sample of cases included various types of gastric cancer in the East and the West, and evenly covered the molecular types required for the study.
, Carefully considered the highly heterogeneous problem of gastric cancer treatment; the setting of the two main research endpoints of OS and PFS can focus on the unique advantages of long-term effectiveness and long-term survival after immunotherapy benefits, and emphasize the lack of specific markers The actual needs of gastric cancer in clinical treatment practice.
The study set up two experimental groups to explore the use of nivolumumab combined with chemotherapy or nivolumumab combined with ipilimumab for chemotherapy-initiated HER2-negative, advanced or metastatic gastric cancer, gastroesophageal junction cancer And the efficacy and safety of patients with esophageal adenocarcinoma.
The preliminary results announced at the ESMO Conference in 2020 are only the specific data of the immune combined chemotherapy group compared to the chemotherapy group.
The research endpoints include: Primary endpoint: PD-L1 expression is positive, that is, the combined positive score (CPS) ≥ 5 OS and PFS (based on blindness).
Independent Central Review Committee BICR assessment) Secondary endpoints: PD-L1 positive and CPS ≥1 patients and all randomized patients with OS; PD-L1 positive and CPS ≥10 patients with OS; PD-L1 positive and CPS ≥10, ≥ 1 PFS of patients and all randomized patients; objective response rate (ORR, based on BICR assessment). Record-breaking survival benefits According to the overall population data of the CheckMate-649 study released in the first round, clinically significant and statistically significant OS benefits were observed in PD-L1 CPS ≥5, CPS ≥1 and all random populations : In patients with PD-L1 CPS ≥5, the median OS was prolonged by nearly 3 months to 14.
4 months; in patients with PD-L1 positive and CPS ≥1, the median OS was also prolonged by nearly 3 months, reaching 14.
0 months; in all random populations, the median OS was extended by nearly 2 months to 13.
8 months.
OS (PD-L1 CPS ≥ 5, PD-L1 CPS ≥ 1, all random populations) It can be seen that the CheckMate-649 study has successfully crossed the "hurdle" of chemotherapy, which generally survived less than one year.
From the survival chart, whether it is PD-L1 CPS ≥ 5, PD-L1 CPS ≥ 1 or all random populations, the two curves of the experimental group and the control group have been separated very early in the study, representing the continued benefit.
In addition to OS, the excellent results of PFS in selected populations can be said to be a "dingxin pill" for subsequent frontline immunotherapy research for gastric cancer.
In the study, in patients with PD-L1 CPS ≥5, clinically significant and statistically significant PFS benefits were observed: the median FPS was extended by nearly 2 months to 7.
7 months.
PFS (PD-L1 CPS ≥ 5) Everything is difficult at the beginning.
The success of the CheckMate-649 study opened a precedent for immunotherapy in the front line of gastric cancer.
The significance of this research is not only expected to change the first-line standard treatment of gastric cancer, but also triggered and gave clinicians and patients the attention and confidence in gastric cancer immunotherapy.
We expect that the Chinese subgroup data of this study will also make history and bring hope to more Chinese patients with advanced gastric cancer.
On April 10, 2021, 20:30 Beijing time, the American Association for Cancer Research Annual Meeting (AACR) CheckMate-649 research Chinese subgroup data will be released soon
In 2020, at the annual meeting of the European Society of Medical Oncology (ESMO), the results of a clinical study called CheckMate-649 confirmed that nivolumab (Odivo, O drug) combined with chemotherapy , Compared with chemotherapy alone, used in the first-line treatment of gastric cancer and esophageal cancer, it can significantly improve overall survival (OS) and disease-free survival (PFS).
In 2021, according to the latest agenda of the American Association for Cancer Research (AACR) annual meeting, the largest randomized controlled, global phase III clinical study CheckMate-649 data from the Chinese subgroup of the CheckMate-649 study in the field of gastric cancer and esophageal adenocarcinoma will soon be available.
It will be released on AACR on April 10 (this Saturday).
For a long time, chemotherapy has been the first-line standard treatment for patients with advanced HER2-negative gastric or gastroesophageal junction cancer, but the survival benefit of newly treated patients is usually less than one year after chemotherapy alone.
For more than ten years, the academic community has spared no effort to explore more effective and innovative therapies, but it has never been able to do so.
Even after tumor therapy has entered the immune era, multiple PD-1/PD-L1 inhibitor-based therapies have all come back.
Does immunotherapy have clinical value in the first-line treatment of advanced or metastatic gastric cancer? This unresolved question was finally confirmed by CheckMate-649 research on the dual superiority results of OS and PFS until August last year.
The results showed that nivolumab combined with chemotherapy for the first-line treatment of advanced gastric cancer has an OS of 14.
4 months and a PFS of 7.
7 months in patients with CPS ≥ 5, which are significantly better than chemotherapy alone (11.
1 months; 6.
0 cases) Months); At the same time, OS benefit was also observed in patients with CPS ≥ 1 and all randomized patients.
This is the first major breakthrough in the first-line treatment of HER2-negative advanced gastric cancer in more than ten years.
It eliminates clinical controversy on the immunotherapy of gastric cancer and confirms the value of immune combined chemotherapy in the first-line treatment of gastric cancer. Based on the results of this study, the National Comprehensive Cancer Network (NCCN) 2021 latest gastric cancer guidelines added a recommendation for nivolumab combined with chemotherapy for the treatment of inoperable locally advanced, recurrent or metastatic HER2-negative gastric cancer.
So, is the first-line treatment effect and safety of nivolumab combined with chemotherapy for Chinese patients with metastatic gastric cancer and gastroesophageal junction cancer consistent with the results of the entire population? On the eve of the release of the Chinese subgroup data of the CheckMate-649 study, let’s review the research design and overall population results of this study: The high-standard study design CheckMate-649 is the largest scale of development in the field of gastric cancer and esophageal adenocarcinoma so far.
The global phase III clinical study.
The overall study included a total of 2031 patients from 176 research centers in many countries and regions around the world (among them, the Chinese population accounted for 13.
4%).
The large sample of cases included various types of gastric cancer in the East and the West, and evenly covered the molecular types required for the study.
, Carefully considered the highly heterogeneous problem of gastric cancer treatment; the setting of the two main research endpoints of OS and PFS can focus on the unique advantages of long-term effectiveness and long-term survival after immunotherapy benefits, and emphasize the lack of specific markers The actual needs of gastric cancer in clinical treatment practice.
The study set up two experimental groups to explore the use of nivolumumab combined with chemotherapy or nivolumumab combined with ipilimumab for chemotherapy-initiated HER2-negative, advanced or metastatic gastric cancer, gastroesophageal junction cancer And the efficacy and safety of patients with esophageal adenocarcinoma.
The preliminary results announced at the ESMO Conference in 2020 are only the specific data of the immune combined chemotherapy group compared to the chemotherapy group.
The research endpoints include: Primary endpoint: PD-L1 expression is positive, that is, the combined positive score (CPS) ≥ 5 OS and PFS (based on blindness).
Independent Central Review Committee BICR assessment) Secondary endpoints: PD-L1 positive and CPS ≥1 patients and all randomized patients with OS; PD-L1 positive and CPS ≥10 patients with OS; PD-L1 positive and CPS ≥10, ≥ 1 PFS of patients and all randomized patients; objective response rate (ORR, based on BICR assessment). Record-breaking survival benefits According to the overall population data of the CheckMate-649 study released in the first round, clinically significant and statistically significant OS benefits were observed in PD-L1 CPS ≥5, CPS ≥1 and all random populations : In patients with PD-L1 CPS ≥5, the median OS was prolonged by nearly 3 months to 14.
4 months; in patients with PD-L1 positive and CPS ≥1, the median OS was also prolonged by nearly 3 months, reaching 14.
0 months; in all random populations, the median OS was extended by nearly 2 months to 13.
8 months.
OS (PD-L1 CPS ≥ 5, PD-L1 CPS ≥ 1, all random populations) It can be seen that the CheckMate-649 study has successfully crossed the "hurdle" of chemotherapy, which generally survived less than one year.
From the survival chart, whether it is PD-L1 CPS ≥ 5, PD-L1 CPS ≥ 1 or all random populations, the two curves of the experimental group and the control group have been separated very early in the study, representing the continued benefit.
In addition to OS, the excellent results of PFS in selected populations can be said to be a "dingxin pill" for subsequent frontline immunotherapy research for gastric cancer.
In the study, in patients with PD-L1 CPS ≥5, clinically significant and statistically significant PFS benefits were observed: the median FPS was extended by nearly 2 months to 7.
7 months.
PFS (PD-L1 CPS ≥ 5) Everything is difficult at the beginning.
The success of the CheckMate-649 study opened a precedent for immunotherapy in the front line of gastric cancer.
The significance of this research is not only expected to change the first-line standard treatment of gastric cancer, but also triggered and gave clinicians and patients the attention and confidence in gastric cancer immunotherapy.
We expect that the Chinese subgroup data of this study will also make history and bring hope to more Chinese patients with advanced gastric cancer.
On April 10, 2021, 20:30 Beijing time, the American Association for Cancer Research Annual Meeting (AACR) CheckMate-649 research Chinese subgroup data will be released soon
