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The 2021 American Association for Cancer Research (AACR) Annual Meeting will be held online on April 10-15 and May 17-21, 2021.
This annual conference covers the most cutting-edge research results in the field of tumor research.
In the clinical research panel, the IMvigor130 study announced the results of the study of immune single-drug vs chemotherapy.
The details are as follows.
Background: Preliminary analysis of IMvigor130 showed that atilizumab (group B) was used for placebo + chemotherapy (platinum + gemcitabine) (group C) for PD-L1 expression ≥5% (immune cells) (IC2/3, VENTANA SP142 immunohistochemical method) When initially treating advanced or metastatic urothelial carcinoma, OS has a tendency to improve.
This meeting reported the results of the second interim OS analysis of group B versus group C, including patients who were not suitable for cisplatin.
Methods: The patients were randomly assigned to group A (atelizumab + chemotherapy), group B and group C at a ratio of 1:1:1.
The primary endpoint is OS.
Secondary endpoints include ORR, DoR, and safety.
In addition, the researchers also performed an exploratory subgroup analysis of OS in patients with different PD-L1 levels in the ITT population and patients who are not suitable for cisplatin.
Results: As of June 14, 2020, the median follow-up time was 13.
3 months.
An exploratory subgroup analysis showed that compared with group C, the median OS of PD-L1 IC2/3 patients in group B was better, and B The median OS of group and C was 27.
5 months and 16.
7 months, respectively (HR=0.
67).
Among PD-L1 IC2/3 patients who are not suitable for cisplatin therapy, compared with group C, the OS of group B was better, and the median OS of group B and group C were 18.
6 months and 10 months, respectively (HR= 0.
6).Among the ITT population, the ORR of group C (44.
1%) was higher than that of group B (23.
4%), and the median DoR of group B (29.
6 months) was longer than that of group C (8.
1 months).
Table OS interim analysis results.
In the safety population, the incidence of grade 3/4 treatment-related adverse events in group B and C was 16% and 80%, respectively, and the incidence of grade 5 treatment-related adverse events was 1%.
Conclusion: The exploratory analysis of the IMvigor130 study update OS results showed that first-line treatment with atilizumab can bring survival benefits to patients with PD-L1 IC2/3 and cisplatin-intolerant metastatic urothelial cancer.
Atelizumab was better tolerated, and with the extension of follow-up time, no new safety events occurred.
Reference: CT040-Updated overall survival (OS) analysis of atezolizumab (atezo) monotherapy vs chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (mUC) in IMvigor130
This annual conference covers the most cutting-edge research results in the field of tumor research.
In the clinical research panel, the IMvigor130 study announced the results of the study of immune single-drug vs chemotherapy.
The details are as follows.
Background: Preliminary analysis of IMvigor130 showed that atilizumab (group B) was used for placebo + chemotherapy (platinum + gemcitabine) (group C) for PD-L1 expression ≥5% (immune cells) (IC2/3, VENTANA SP142 immunohistochemical method) When initially treating advanced or metastatic urothelial carcinoma, OS has a tendency to improve.
This meeting reported the results of the second interim OS analysis of group B versus group C, including patients who were not suitable for cisplatin.
Methods: The patients were randomly assigned to group A (atelizumab + chemotherapy), group B and group C at a ratio of 1:1:1.
The primary endpoint is OS.
Secondary endpoints include ORR, DoR, and safety.
In addition, the researchers also performed an exploratory subgroup analysis of OS in patients with different PD-L1 levels in the ITT population and patients who are not suitable for cisplatin.
Results: As of June 14, 2020, the median follow-up time was 13.
3 months.
An exploratory subgroup analysis showed that compared with group C, the median OS of PD-L1 IC2/3 patients in group B was better, and B The median OS of group and C was 27.
5 months and 16.
7 months, respectively (HR=0.
67).
Among PD-L1 IC2/3 patients who are not suitable for cisplatin therapy, compared with group C, the OS of group B was better, and the median OS of group B and group C were 18.
6 months and 10 months, respectively (HR= 0.
6).Among the ITT population, the ORR of group C (44.
1%) was higher than that of group B (23.
4%), and the median DoR of group B (29.
6 months) was longer than that of group C (8.
1 months).
Table OS interim analysis results.
In the safety population, the incidence of grade 3/4 treatment-related adverse events in group B and C was 16% and 80%, respectively, and the incidence of grade 5 treatment-related adverse events was 1%.
Conclusion: The exploratory analysis of the IMvigor130 study update OS results showed that first-line treatment with atilizumab can bring survival benefits to patients with PD-L1 IC2/3 and cisplatin-intolerant metastatic urothelial cancer.
Atelizumab was better tolerated, and with the extension of follow-up time, no new safety events occurred.
Reference: CT040-Updated overall survival (OS) analysis of atezolizumab (atezo) monotherapy vs chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (mUC) in IMvigor130
