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The 2021 European Society of Medical Oncology Annual Meeting (ESMO 2021) will be held from September 16 to 21, local time
.
In the gastrointestinal cancer (non-colorectal cancer) special session, a number of major gastrointestinal cancer researches were unveiled at the conference
.
The data of two phase III clinical studies conducted by Sintilimab in the field of esophageal cancer and gastric cancer were published for the first time.
They were reported by Professor Lin Lin from Peking University Cancer Hospital and Professor Xu Jianming from the Fifth Medical Center of PLA General Hospital respectively
.
Sintilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance , To reactivate the anti-tumor activity of lymphocytes, so as to achieve the purpose of treating tumors
.
Esophageal Cancer Title: Interim Analysis Results of a Phase III Clinical Study of Sintilimab Combined with Chemotherapy and Chemotherapy in the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15) Report Type: Mini Oral Report Abstract Number: LBA52 Investigator: Shen Professor Lin (Peking University Cancer Hospital) ORIENT-15 is a global, randomized, double-blind clinical study designed to evaluate sintilimab combined with chemotherapy (S + C) versus chemotherapy (C) for the first-line (1L) treatment of unresectable The efficacy and safety of patients with locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
.
Methods: Eligible patients were randomized to receive sintilimab or placebo 200 mg Q3W combined chemotherapy (TP: paclitaxel 175 mg/m2 Q3W + cisplatin 75 mg/m2 Q3W or CF: cisplatin 75 at a 1:1 ratio) mg/m2 Q3W + 5-FU 800 mg/m2, d1-5 Q3W) for 24 months
.
Randomization stratified according to ECOG PS (0 vs 1), liver metastasis (with vs without), and chemotherapy regimen (TP vs CF)
.
Treatment is continued until the disease progresses, unacceptable toxicity occurs, or the study is withdrawn, and no crossover is allowed
.
The primary study endpoint is the overall survival (OS) of the overall population and PD-L1 positive (CPS≥10) population
.
The secondary endpoints are the progression-free survival (PFS) and objective response rate (ORR) (RECIST v1.
1; assessed by the investigator) in the overall population and PD-L1 positive (CPS≥10) population
.
The data deadline for the interim analysis is April 9, 2021
.
Results: At the time of the data cut-off, 659 patients (86% males, 97% Chinese, 87% metastases) (327 cases in S + C group, 332 cases in C group) were randomized and stratified for treatment
.
The median follow-up time was 11.
4 months
.
In the overall population and the PD-L1 positive (CPS≥10) population, the OS and PFS of the S+C group were better than those of the C group.
The details are as follows: Median OS: Overall population: 16.
7 vs 12.
5 months (HR 0.
628, 95 %CI 0.
508-0.
777), P <0.
0001; PD-L1 positive population: 17.
2 vs 13.
6 months (HR 0.
638, 95% CI 0.
480-0.
848), P=0.
0018
.
Median PFS: Overall population: 7.
2 vs 5.
7 months, HR 0.
558, 95%CI 0.
461-0.
676, P <0.
0001; PD-L1 positive population: 8.
3 vs 6.
4 months, HR 0.
580, 95% CI 0.
449-0.
749, P <0.
0001
.
ORR: Overall population: 75.
5% vs 56.
9%; PD-L1 positive population: 78.
7% vs 57.
5%
.
DOR: Overall population: 8.
3 vs 5.
6 months; PD-L1 positive population: 8.
5 vs 5.
5 months
.
Among patients who received at least one dose of drug therapy, the incidence of treatment-related adverse events (TRAE) was 98.
2% in both groups
.
Compared with group C, the incidence of grade 3 TRAE in the S+C group was 59.
9% vs 54.
5%, the discontinuation rate was 20.
8% vs 12.
3%, and the death rate was 2.
8% vs 1.
8%
.
Conclusion: Compared with chemotherapy, the OS, PFS and ORR of patients with sintilimab combined with chemotherapy are significantly improved, and the safety characteristics of PD-L1 positive (CPS≥10) patients and all patients are controllable
.
Especially in the overall population, the HR of OS is less than 0.
7
.
The results prove that sintilimab combined with chemotherapy can be considered as a new first-line treatment option for patients with advanced or metastatic ESCC
.
Gastric Cancer Title: Interim Analysis Results of a Phase III Randomized Controlled Study of Sintilimab Combined with Chemotherapy vs.
Placebo and Chemotherapy for First-line Treatment of Unresectable or Metastatic Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma (ORIENT-16) Report type: mini oral report Abstract number: LBA53 Investigator: Professor Xu Jianming (Fifth Medical Center of PLA General Hospital) ORIENT-16 is a randomized, double-blind, phase III trial designed to evaluate sintilizumab combined with chemotherapy ( S + C) Compare the efficacy and safety of chemotherapy (C) in the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma
.
Methods: Eligible patients are untreated unresectable, locally advanced or metastatic G/GEJ adenocarcinoma adults (≥18 years old), regardless of the expression of PD-L1
.
Patients were randomized 1:1 to receive Sintilizumab (3 mg/kg and 200 mg intravenously, Q3W, respectively, weight <60 kg and ≥ 60 kg) or placebo combined with chemotherapy (CapeOX: oxaliplatin 130 mg/m2) Intravenous injection of Q3W, up to 6 cycles, capecitabine 1000 mg/m2 oral Bid d1-14 Q3W) for 24 months
.
The primary endpoint was OS in patients with CPS ≥ 5 and all randomized patients
.
The data deadline for the interim analysis is June 20, 2021
.
Results: As of the data cutoff date, a total of 650 patients received randomization (327 in S + C group, 323 in C group) treatment, including 397 (61.
1%) patients with CPS ≥ 5
.
The median follow-up time was 18.
8 months (range 0.
0-29.
1)
.
Compared with group C, patients in group S + C with CPS ≥ 5 (median OS: 18.
4 vs 12.
9 months; HR 0.
660; 95% CI 0.
505-0.
864; P=0.
0023) and all patients (median OS: 15.
2 vs.
12.
3 months; HR 0.
766; 95%CI 0.
626-0.
936; P=0.
0090) OS was significantly improved
.
OS benefit was observed in all patients with pre-defined CPS cut-off values (CPS ≥ 1, 5, and 10)
.
S + C CPS≥5 group of patients (HR 0.
628; 95% CI 0.
489-0.
805 ; P = 0.
0002) , and all patients (HR 0.
636; 95% CI 0.
525-0.
771 ; P <0.
0001) than in Group of PFS C
.
Compared with group C, the unconfirmed ORR of patients with CPS ≥ 5 was 72.
8% vs 59.
6%, and the median DOR was 8.
4 vs 5.
5 months.
The unconfirmed ORR of all patients with measurable lesions was 65.
1% vs 58.
7.
%, the median DOR was 8.
6 vs 5.
5 months, respectively
.
Among all patients receiving treatment, 196 (59.
8%) of the 328 patients in the S + C group had Grade 3 treatment-related adverse events (TRAE), and 168 (52.
5%) of the 320 patients in the C group
.
Six patients (1.
8%) in the S + C group and 2 patients (0.
6%) in the C group had TRAE that led to death
.
Conclusion: Sintilimab is the first PD-1 inhibitor that combines chemotherapy with OS and PFS in G/GEJ Chinese patients who do not consider PD-L1 expression and has a better performance and acceptable safety characteristics
.
Sintilimab combined with chemotherapy provides a new standard first-line treatment option for these patients
.
References: 1.
LBA52-Sintilimab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced or metastatic esophageal squamous cell cancer: First results of the phase III ORIENT-15 study.
Presented at: 2021 ESMO Congress; September 16-21 , 2021; virtual.
2.
LBA53-Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): First results of a randomized, double-blind, phase III study.
Presented at: 2021 ESMO Congress; September 16-21, 2021; virtual.
.
In the gastrointestinal cancer (non-colorectal cancer) special session, a number of major gastrointestinal cancer researches were unveiled at the conference
.
The data of two phase III clinical studies conducted by Sintilimab in the field of esophageal cancer and gastric cancer were published for the first time.
They were reported by Professor Lin Lin from Peking University Cancer Hospital and Professor Xu Jianming from the Fifth Medical Center of PLA General Hospital respectively
.
Sintilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance , To reactivate the anti-tumor activity of lymphocytes, so as to achieve the purpose of treating tumors
.
Esophageal Cancer Title: Interim Analysis Results of a Phase III Clinical Study of Sintilimab Combined with Chemotherapy and Chemotherapy in the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15) Report Type: Mini Oral Report Abstract Number: LBA52 Investigator: Shen Professor Lin (Peking University Cancer Hospital) ORIENT-15 is a global, randomized, double-blind clinical study designed to evaluate sintilimab combined with chemotherapy (S + C) versus chemotherapy (C) for the first-line (1L) treatment of unresectable The efficacy and safety of patients with locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
.
Methods: Eligible patients were randomized to receive sintilimab or placebo 200 mg Q3W combined chemotherapy (TP: paclitaxel 175 mg/m2 Q3W + cisplatin 75 mg/m2 Q3W or CF: cisplatin 75 at a 1:1 ratio) mg/m2 Q3W + 5-FU 800 mg/m2, d1-5 Q3W) for 24 months
.
Randomization stratified according to ECOG PS (0 vs 1), liver metastasis (with vs without), and chemotherapy regimen (TP vs CF)
.
Treatment is continued until the disease progresses, unacceptable toxicity occurs, or the study is withdrawn, and no crossover is allowed
.
The primary study endpoint is the overall survival (OS) of the overall population and PD-L1 positive (CPS≥10) population
.
The secondary endpoints are the progression-free survival (PFS) and objective response rate (ORR) (RECIST v1.
1; assessed by the investigator) in the overall population and PD-L1 positive (CPS≥10) population
.
The data deadline for the interim analysis is April 9, 2021
.
Results: At the time of the data cut-off, 659 patients (86% males, 97% Chinese, 87% metastases) (327 cases in S + C group, 332 cases in C group) were randomized and stratified for treatment
.
The median follow-up time was 11.
4 months
.
In the overall population and the PD-L1 positive (CPS≥10) population, the OS and PFS of the S+C group were better than those of the C group.
The details are as follows: Median OS: Overall population: 16.
7 vs 12.
5 months (HR 0.
628, 95 %CI 0.
508-0.
777), P <0.
0001; PD-L1 positive population: 17.
2 vs 13.
6 months (HR 0.
638, 95% CI 0.
480-0.
848), P=0.
0018
.
Median PFS: Overall population: 7.
2 vs 5.
7 months, HR 0.
558, 95%CI 0.
461-0.
676, P <0.
0001; PD-L1 positive population: 8.
3 vs 6.
4 months, HR 0.
580, 95% CI 0.
449-0.
749, P <0.
0001
.
ORR: Overall population: 75.
5% vs 56.
9%; PD-L1 positive population: 78.
7% vs 57.
5%
.
DOR: Overall population: 8.
3 vs 5.
6 months; PD-L1 positive population: 8.
5 vs 5.
5 months
.
Among patients who received at least one dose of drug therapy, the incidence of treatment-related adverse events (TRAE) was 98.
2% in both groups
.
Compared with group C, the incidence of grade 3 TRAE in the S+C group was 59.
9% vs 54.
5%, the discontinuation rate was 20.
8% vs 12.
3%, and the death rate was 2.
8% vs 1.
8%
.
Conclusion: Compared with chemotherapy, the OS, PFS and ORR of patients with sintilimab combined with chemotherapy are significantly improved, and the safety characteristics of PD-L1 positive (CPS≥10) patients and all patients are controllable
.
Especially in the overall population, the HR of OS is less than 0.
7
.
The results prove that sintilimab combined with chemotherapy can be considered as a new first-line treatment option for patients with advanced or metastatic ESCC
.
Gastric Cancer Title: Interim Analysis Results of a Phase III Randomized Controlled Study of Sintilimab Combined with Chemotherapy vs.
Placebo and Chemotherapy for First-line Treatment of Unresectable or Metastatic Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma (ORIENT-16) Report type: mini oral report Abstract number: LBA53 Investigator: Professor Xu Jianming (Fifth Medical Center of PLA General Hospital) ORIENT-16 is a randomized, double-blind, phase III trial designed to evaluate sintilizumab combined with chemotherapy ( S + C) Compare the efficacy and safety of chemotherapy (C) in the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma
.
Methods: Eligible patients are untreated unresectable, locally advanced or metastatic G/GEJ adenocarcinoma adults (≥18 years old), regardless of the expression of PD-L1
.
Patients were randomized 1:1 to receive Sintilizumab (3 mg/kg and 200 mg intravenously, Q3W, respectively, weight <60 kg and ≥ 60 kg) or placebo combined with chemotherapy (CapeOX: oxaliplatin 130 mg/m2) Intravenous injection of Q3W, up to 6 cycles, capecitabine 1000 mg/m2 oral Bid d1-14 Q3W) for 24 months
.
The primary endpoint was OS in patients with CPS ≥ 5 and all randomized patients
.
The data deadline for the interim analysis is June 20, 2021
.
Results: As of the data cutoff date, a total of 650 patients received randomization (327 in S + C group, 323 in C group) treatment, including 397 (61.
1%) patients with CPS ≥ 5
.
The median follow-up time was 18.
8 months (range 0.
0-29.
1)
.
Compared with group C, patients in group S + C with CPS ≥ 5 (median OS: 18.
4 vs 12.
9 months; HR 0.
660; 95% CI 0.
505-0.
864; P=0.
0023) and all patients (median OS: 15.
2 vs.
12.
3 months; HR 0.
766; 95%CI 0.
626-0.
936; P=0.
0090) OS was significantly improved
.
OS benefit was observed in all patients with pre-defined CPS cut-off values (CPS ≥ 1, 5, and 10)
.
S + C CPS≥5 group of patients (HR 0.
628; 95% CI 0.
489-0.
805 ; P = 0.
0002) , and all patients (HR 0.
636; 95% CI 0.
525-0.
771 ; P <0.
0001) than in Group of PFS C
.
Compared with group C, the unconfirmed ORR of patients with CPS ≥ 5 was 72.
8% vs 59.
6%, and the median DOR was 8.
4 vs 5.
5 months.
The unconfirmed ORR of all patients with measurable lesions was 65.
1% vs 58.
7.
%, the median DOR was 8.
6 vs 5.
5 months, respectively
.
Among all patients receiving treatment, 196 (59.
8%) of the 328 patients in the S + C group had Grade 3 treatment-related adverse events (TRAE), and 168 (52.
5%) of the 320 patients in the C group
.
Six patients (1.
8%) in the S + C group and 2 patients (0.
6%) in the C group had TRAE that led to death
.
Conclusion: Sintilimab is the first PD-1 inhibitor that combines chemotherapy with OS and PFS in G/GEJ Chinese patients who do not consider PD-L1 expression and has a better performance and acceptable safety characteristics
.
Sintilimab combined with chemotherapy provides a new standard first-line treatment option for these patients
.
References: 1.
LBA52-Sintilimab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced or metastatic esophageal squamous cell cancer: First results of the phase III ORIENT-15 study.
Presented at: 2021 ESMO Congress; September 16-21 , 2021; virtual.
2.
LBA53-Sintilimab plus chemotherapy (chemo) versus chemo as first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-16): First results of a randomized, double-blind, phase III study.
Presented at: 2021 ESMO Congress; September 16-21, 2021; virtual.
