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JUPITER-06 research ◆Professor Wang Feng's in-depth interpretation ◆2021 ESMO esophageal cancer immunotherapy is back.
At the 2021 European Society of Medical Oncology (ESMO) conference just held, Professor Wang Feng from the team of Professor Xu Ruihua from Sun Yat-sen University Cancer Hospital reported JUPITER-06 The results of the interim analysis of the study showed that the addition of teriprizumab to chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) significantly improved progression-free survival (PFS) and overall survival (OS) compared with chemotherapy.
), and the research group’s OS has reached a record high of 17.
0 months, which is the longest known OS in similar phase III trials.
Such excellent data is believed to further promote the update of domestic and international guidelines
.
This platform specially invited Professor Wang Feng from the team of PI Professor Ruihua Xu who studied JUPITER-06 to deeply interpret the meaning behind the research results
.
JUPITER-06 research, median OS 17.
0 months breakthrough, stunning debut! Esophageal cancer is a high-incidence malignant tumor worldwide, and the incidence ranks 7th among common cancers.
Among them, 50% of new cases occur in China.
In China, esophageal cancer is dominated by squamous cell carcinoma.
The main difference is adenocarcinoma
.
For a long time, the standard first-line treatment for advanced ESCC is platinum-containing dual-agent chemotherapy, but the efficacy is limited, the prognosis of patients is not optimistic, and the 5-year survival rate is less than 20%
.
Teriplizumab is a humanized monoclonal antibody against PD-1.
The study released by our team at the ASCO conference in 2019 showed that teriplizumab is a single agent in the late or late stage of previous treatment.
Patients with metastatic ESCC showed anti-tumor activity, the objective remission rate was 18.
6%, and the safety was good
.
Therefore, we designed this phase III JUPITER-06 study to verify the efficacy and safety of teriplimumab combined with paclitaxel and cisplatin (TP) compared with TP for first-line treatment of advanced or metastatic ESCC.
We hope this program It can break the bottleneck of the chemotherapy effect of ESCC
.
At this ESMO conference, Professor Wang Feng of Xu Ruihua's team reported the interim analysis results of the research in the form of Mini Oral
.
The common primary endpoint of PFS and OS is reached, and a new standard will be added to the first-line treatment of ESCC.
JUPITER-06 is a randomized double-blind phase III clinical trial led by our Sun Yat-sen University Affiliated Tumor Hospital.
A total of 70 centers across the country participated.
The clinical centers and the patients and their families who participated in the trial expressed their heartfelt gratitude
.
The study enrolled newly treated patients with advanced or metastatic ESCC and randomly assigned them to the group at 1:1.
They were given teriplizumab or placebo combined with TP chemotherapy, every 3 weeks for 1 cycle, up to 6 cycles; then Teriplizumab or placebo is maintained for up to 2 years, or the treatment has progressed until the disease has progressed, untolerable toxicity occurs, or the consent form is withdrawn (Figure 1)
.
Finally, 514 patients were enrolled, 257 patients in each of the teriprizumab + chemotherapy and placebo + chemotherapy groups
.
Figure 1.
Study design.
At the time of the planned interim analysis by the data deadline of March 22, 2021, the median follow-up time for the two groups was 7.
4 months and 7.
3 months, respectively
.
Compared with placebo + chemotherapy, teriprizumab + chemotherapy significantly reduced the risk of disease progression or death by 42% (HR = 0.
58, P<0.
00001), and the median PFS was 5.
7 months and 5.
5 months, respectively, for 1 year The PFS rates were 27.
8% and 6.
1% (Figure 2)
.
Figure 2.
PFS results.
Similarly, in terms of OS, the teriprizumab + chemotherapy group also got a significant improvement, the risk of death was reduced by 42% (HR=0.
58, P=0.
00036), and the median OS was 17.
0 months and 11.
0, respectively Month, 1-year OS rates were 66.
0% and 43.
7%, and 2-year OS rates were non-evaluable (NE) and 17.
5% (Figure 3)
.
Figure 3.
OS results.
The results of the JUPITER-06 study perfectly met our expectations.
The two study endpoints, PFS and OS, were reached, and tereprizumab showed consistently good safety and tolerability.
Therefore, we It is confident that teriprizumab combined with TP chemotherapy will become the new first-line standard treatment for advanced or metastatic ESCC
.
The median OS is 17.
0 months, a record high in the survival time of immune combined chemotherapy.
Among the 4 reported studies, the immune combined chemotherapy group of JUPITER-06 achieved the longest median OS (Figure 4), reaching 17.
0 months.
The OS of the TP chemotherapy group was 11.
0 months, and the OS of 11.
0 months was also consistent with the previous efficacy results of the chemotherapy regimen
.
In the past few decades, the first-line treatment of advanced esophageal cancer has always been based on fluorouracil or paclitaxel combined with platinum chemotherapy.
In recent years, China has mainly relied on paclitaxel combined with platinum.
It is difficult to exceed 12 months.
Compared with chemotherapy alone, the prolonged survival period of up to 6 months is of great clinical significance
.
Figure 4.
OS results of the published phase III study of esophageal cancer immunotherapy combined with chemotherapy.
Observe the PFS and OS curves of JUPITER-06.
The two groups are separated at the beginning of treatment, and the more time passes, the two curves are divided.
The more open (Figure 2, Figure 4), fully reflects the "tailing effect" of the therapeutic effect of immunotherapy
.
Although the median PFS value between teriplizumab + chemotherapy and chemotherapy alone does not seem to be much different (5.
7 months vs 5.
5 months), the survival curve gradually separates in the later period, and there is a very large gap in the 1-year PFS rate.
(27.
8% vs 6.
1%, P＜0.
00001), also stems from this principle
.
The study design of JUPITER-06 and ESCORT-1st is very similar.
The enrolled population is the Chinese ESCC population.
The combined chemotherapy regimen is TP.
The proportion of metastatic patients is similar.
The primary endpoint is the common endpoint of PFS and OS.
The two studies have achieved similar PFS and OS results, with PFS HR of 0.
58 and 0.
56, and OS HR of 0.
70 and 0.
58, respectively
.
The OS results of JUPITER-06 have more obvious advantages .
The first-line immunotherapy for esophageal cancer is about to enter the era of “Warring States Contending for Hegemony”.
Domestic and foreign immune preparations have been approved for the treatment of esophageal cancer.
According to different disease types and stages, the recommendations are also different.
At present, the domestic front-line advanced esophageal cancer Pembrolizumab is the only treatment
.
The results of the JUPITER-06 study are encouraging.
Compared with chemotherapy alone, terreplimumab combined with chemotherapy for first-line treatment of advanced or metastatic esophageal cancer not only significantly reduces the patient’s risk of death, but also prolongs the median OS by 6 months The 17.
0-month OS in this group set the longest record of similar phase III trials, and the safety and tolerability were good
.
We look forward to the release of the late-stage data of the JUPITER-06 study, which will benefit esophageal cancer patients in China and even the world! The Mini Oral report and panel discussion on the ESMO site fully reflected the weight of the JUPITOR-06 research
.
National forces, international voices, and innovation are our missions.
So far, imported pembrolizumab and nivolizumab, as well as nationally developed carrelizumab and tereprizumab have entered the front line of esophageal cancer.
On the premise that the curative effect is confirmed, safety and price are the further factors of strength competition.
The price advantage of domestic drugs over imported drugs is self-evident.
The consistent and stable safety performance of teriprizumab is also one of the advantages.
Looking forward to Terry The wonderful performance of Pulizumab in various fields in the future! [Expert profile] Professor Xu Ruihua, Dean and Director of Sun Yat-Sen University Cancer Center, Chief Expert and Professor of Colorectal Cancer, Nanyue Baijie, Doctoral Tutor of the National Hundred and Thousand Talents Engineering, Director of the State Key Laboratory of Oncology in South China National New Drug (Antitumor Drugs) Director of Clinical Trial Center Expert of Special Government Allowance of the State Council Member of the Department of Biology and Medicine, Ministry of Education, Science and Technology Committee, Vice Chairman, Chinese Anti-Cancer Association, Vice Chairman, Chinese Society of Clinical Oncology (CSCO), Vice Chairman, Chinese Medical Biotechnology Association, Guangdong Chairman of the Provincial Anti-Cancer Association Chairman of the Gastric Cancer Committee of the Chinese Society of Clinical Oncology Cancer Communications Chief Editor of the National Food and Drug Administration (CFDA) Drug Review Consultant Professor Wang Feng Deputy Director of the Department of Internal Medicine, Sun Yat-sen University Cancer Center, Chief Physician/Researcher MD Anderson Oncology Center Doctor, Ministry of Education, Young Changjiang Scholar, Vice Chairman of the Youth Committee of the Chinese Anti-Cancer Association Targeted Tumor Therapy Professional Committee, Chairman of the Youth Committee of the Guangdong Anti-Cancer Association Tumor Targeted Therapy Professional Committee, Director of the Youth Council of the Chinese Anti-Cancer Association Director of the Chinese Society of Clinical Oncology The Standing Committee of the Youth Committee of the Chinese Society of Clinical Oncology focuses on the medical treatment of gastrointestinal tumors, presides over 7 provincial and ministerial funds including the National Natural Science Foundation of China’s international (regional) cooperation and exchange projects and general projects, and participates in the 863 plan and national key research and development.
Plan and other major project research
.
As the first or corresponding author, he has published more than 40 papers in journals such as "JAMA Oncology", "Cell Research", and "Annals of Oncology".
Prizes and other provincial and ministerial awards
.
He has been invited many times to give oral presentations at the annual meeting of the American Association for Cancer Research and the annual meeting of the Chinese Society of Clinical Oncology
.
Source: Tumor Information
At the 2021 European Society of Medical Oncology (ESMO) conference just held, Professor Wang Feng from the team of Professor Xu Ruihua from Sun Yat-sen University Cancer Hospital reported JUPITER-06 The results of the interim analysis of the study showed that the addition of teriprizumab to chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) significantly improved progression-free survival (PFS) and overall survival (OS) compared with chemotherapy.
), and the research group’s OS has reached a record high of 17.
0 months, which is the longest known OS in similar phase III trials.
Such excellent data is believed to further promote the update of domestic and international guidelines
.
This platform specially invited Professor Wang Feng from the team of PI Professor Ruihua Xu who studied JUPITER-06 to deeply interpret the meaning behind the research results
.
JUPITER-06 research, median OS 17.
0 months breakthrough, stunning debut! Esophageal cancer is a high-incidence malignant tumor worldwide, and the incidence ranks 7th among common cancers.
Among them, 50% of new cases occur in China.
In China, esophageal cancer is dominated by squamous cell carcinoma.
The main difference is adenocarcinoma
.
For a long time, the standard first-line treatment for advanced ESCC is platinum-containing dual-agent chemotherapy, but the efficacy is limited, the prognosis of patients is not optimistic, and the 5-year survival rate is less than 20%
.
Teriplizumab is a humanized monoclonal antibody against PD-1.
The study released by our team at the ASCO conference in 2019 showed that teriplizumab is a single agent in the late or late stage of previous treatment.
Patients with metastatic ESCC showed anti-tumor activity, the objective remission rate was 18.
6%, and the safety was good
.
Therefore, we designed this phase III JUPITER-06 study to verify the efficacy and safety of teriplimumab combined with paclitaxel and cisplatin (TP) compared with TP for first-line treatment of advanced or metastatic ESCC.
We hope this program It can break the bottleneck of the chemotherapy effect of ESCC
.
At this ESMO conference, Professor Wang Feng of Xu Ruihua's team reported the interim analysis results of the research in the form of Mini Oral
.
The common primary endpoint of PFS and OS is reached, and a new standard will be added to the first-line treatment of ESCC.
JUPITER-06 is a randomized double-blind phase III clinical trial led by our Sun Yat-sen University Affiliated Tumor Hospital.
A total of 70 centers across the country participated.
The clinical centers and the patients and their families who participated in the trial expressed their heartfelt gratitude
.
The study enrolled newly treated patients with advanced or metastatic ESCC and randomly assigned them to the group at 1:1.
They were given teriplizumab or placebo combined with TP chemotherapy, every 3 weeks for 1 cycle, up to 6 cycles; then Teriplizumab or placebo is maintained for up to 2 years, or the treatment has progressed until the disease has progressed, untolerable toxicity occurs, or the consent form is withdrawn (Figure 1)
.
Finally, 514 patients were enrolled, 257 patients in each of the teriprizumab + chemotherapy and placebo + chemotherapy groups
.
Figure 1.
Study design.
At the time of the planned interim analysis by the data deadline of March 22, 2021, the median follow-up time for the two groups was 7.
4 months and 7.
3 months, respectively
.
Compared with placebo + chemotherapy, teriprizumab + chemotherapy significantly reduced the risk of disease progression or death by 42% (HR = 0.
58, P<0.
00001), and the median PFS was 5.
7 months and 5.
5 months, respectively, for 1 year The PFS rates were 27.
8% and 6.
1% (Figure 2)
.
Figure 2.
PFS results.
Similarly, in terms of OS, the teriprizumab + chemotherapy group also got a significant improvement, the risk of death was reduced by 42% (HR=0.
58, P=0.
00036), and the median OS was 17.
0 months and 11.
0, respectively Month, 1-year OS rates were 66.
0% and 43.
7%, and 2-year OS rates were non-evaluable (NE) and 17.
5% (Figure 3)
.
Figure 3.
OS results.
The results of the JUPITER-06 study perfectly met our expectations.
The two study endpoints, PFS and OS, were reached, and tereprizumab showed consistently good safety and tolerability.
Therefore, we It is confident that teriprizumab combined with TP chemotherapy will become the new first-line standard treatment for advanced or metastatic ESCC
.
The median OS is 17.
0 months, a record high in the survival time of immune combined chemotherapy.
Among the 4 reported studies, the immune combined chemotherapy group of JUPITER-06 achieved the longest median OS (Figure 4), reaching 17.
0 months.
The OS of the TP chemotherapy group was 11.
0 months, and the OS of 11.
0 months was also consistent with the previous efficacy results of the chemotherapy regimen
.
In the past few decades, the first-line treatment of advanced esophageal cancer has always been based on fluorouracil or paclitaxel combined with platinum chemotherapy.
In recent years, China has mainly relied on paclitaxel combined with platinum.
It is difficult to exceed 12 months.
Compared with chemotherapy alone, the prolonged survival period of up to 6 months is of great clinical significance
.
Figure 4.
OS results of the published phase III study of esophageal cancer immunotherapy combined with chemotherapy.
Observe the PFS and OS curves of JUPITER-06.
The two groups are separated at the beginning of treatment, and the more time passes, the two curves are divided.
The more open (Figure 2, Figure 4), fully reflects the "tailing effect" of the therapeutic effect of immunotherapy
.
Although the median PFS value between teriplizumab + chemotherapy and chemotherapy alone does not seem to be much different (5.
7 months vs 5.
5 months), the survival curve gradually separates in the later period, and there is a very large gap in the 1-year PFS rate.
(27.
8% vs 6.
1%, P＜0.
00001), also stems from this principle
.
The study design of JUPITER-06 and ESCORT-1st is very similar.
The enrolled population is the Chinese ESCC population.
The combined chemotherapy regimen is TP.
The proportion of metastatic patients is similar.
The primary endpoint is the common endpoint of PFS and OS.
The two studies have achieved similar PFS and OS results, with PFS HR of 0.
58 and 0.
56, and OS HR of 0.
70 and 0.
58, respectively
.
The OS results of JUPITER-06 have more obvious advantages .
The first-line immunotherapy for esophageal cancer is about to enter the era of “Warring States Contending for Hegemony”.
Domestic and foreign immune preparations have been approved for the treatment of esophageal cancer.
According to different disease types and stages, the recommendations are also different.
At present, the domestic front-line advanced esophageal cancer Pembrolizumab is the only treatment
.
The results of the JUPITER-06 study are encouraging.
Compared with chemotherapy alone, terreplimumab combined with chemotherapy for first-line treatment of advanced or metastatic esophageal cancer not only significantly reduces the patient’s risk of death, but also prolongs the median OS by 6 months The 17.
0-month OS in this group set the longest record of similar phase III trials, and the safety and tolerability were good
.
We look forward to the release of the late-stage data of the JUPITER-06 study, which will benefit esophageal cancer patients in China and even the world! The Mini Oral report and panel discussion on the ESMO site fully reflected the weight of the JUPITOR-06 research
.
National forces, international voices, and innovation are our missions.
So far, imported pembrolizumab and nivolizumab, as well as nationally developed carrelizumab and tereprizumab have entered the front line of esophageal cancer.
On the premise that the curative effect is confirmed, safety and price are the further factors of strength competition.
The price advantage of domestic drugs over imported drugs is self-evident.
The consistent and stable safety performance of teriprizumab is also one of the advantages.
Looking forward to Terry The wonderful performance of Pulizumab in various fields in the future! [Expert profile] Professor Xu Ruihua, Dean and Director of Sun Yat-Sen University Cancer Center, Chief Expert and Professor of Colorectal Cancer, Nanyue Baijie, Doctoral Tutor of the National Hundred and Thousand Talents Engineering, Director of the State Key Laboratory of Oncology in South China National New Drug (Antitumor Drugs) Director of Clinical Trial Center Expert of Special Government Allowance of the State Council Member of the Department of Biology and Medicine, Ministry of Education, Science and Technology Committee, Vice Chairman, Chinese Anti-Cancer Association, Vice Chairman, Chinese Society of Clinical Oncology (CSCO), Vice Chairman, Chinese Medical Biotechnology Association, Guangdong Chairman of the Provincial Anti-Cancer Association Chairman of the Gastric Cancer Committee of the Chinese Society of Clinical Oncology Cancer Communications Chief Editor of the National Food and Drug Administration (CFDA) Drug Review Consultant Professor Wang Feng Deputy Director of the Department of Internal Medicine, Sun Yat-sen University Cancer Center, Chief Physician/Researcher MD Anderson Oncology Center Doctor, Ministry of Education, Young Changjiang Scholar, Vice Chairman of the Youth Committee of the Chinese Anti-Cancer Association Targeted Tumor Therapy Professional Committee, Chairman of the Youth Committee of the Guangdong Anti-Cancer Association Tumor Targeted Therapy Professional Committee, Director of the Youth Council of the Chinese Anti-Cancer Association Director of the Chinese Society of Clinical Oncology The Standing Committee of the Youth Committee of the Chinese Society of Clinical Oncology focuses on the medical treatment of gastrointestinal tumors, presides over 7 provincial and ministerial funds including the National Natural Science Foundation of China’s international (regional) cooperation and exchange projects and general projects, and participates in the 863 plan and national key research and development.
Plan and other major project research
.
As the first or corresponding author, he has published more than 40 papers in journals such as "JAMA Oncology", "Cell Research", and "Annals of Oncology".
Prizes and other provincial and ministerial awards
.
He has been invited many times to give oral presentations at the annual meeting of the American Association for Cancer Research and the annual meeting of the Chinese Society of Clinical Oncology
.
Source: Tumor Information
