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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 seminar, the IMvigor130 study announced the results of two studies.
CT040: Immune single agent vs placebo + chemotherapy Background: The preliminary analysis of Phase III IMvigor130 showed that atilizumab (group B) was compared with 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.
Exploratory subgroup analysis showed that compared with group C, the median OS of PD-L1 IC2/3 patients in group B was better, and the median OS of group B and group C were 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.
CT042: Immune combination vs placebo + chemotherapy Background: A preliminary study of IMvigor130 shows that compared with placebo + chemotherapy, atilizumab + chemotherapy can significantly improve the PFS of patients with metastatic urothelial cancer, and can improve it to a certain extent Patient OS (the first interim analysis showed that a significant difference was not reached).
This meeting reported the results of the second mid-term OS of group A versus group C.
Methods: The patients were randomly assigned to group A (atelizumab + chemotherapy), group B and group C at a ratio of 1:1:1.
The common primary endpoints were PFS and OS (group A vs.
C, ITT), OS (group B vs.
C, ITT, IC2/3), and secondary endpoints included objective response rate (ORR) and DoR.
Results: As of June 14, 2020, the median follow-up time was 13.
3 months.
In the ITT population, the median OS of group A and group C were 16.
1 months and 13.
4 months, respectively (HR=0.
84, P=0.
026) (not reaching the preset critical value of significant difference P=0.
014).
The median OS of groups A and C who received cisplatin was 21.
6 months and 14.
6 months, respectively, and the median OS of groups A and C who received carboplatin were 14.
3 months and 13 months, respectively. The ORRs of group A and group C were 48% and 45%, respectively, and 7% and 24% of patients in group A and C received immunotherapy outside the study plan.
Table OS interim analysis results.
In the safety analysis, the incidence of grade 3/4 treatment-related adverse events in group A and group C were 81% and 80%, respectively.
No new grade 5 treatment-related adverse events occurred.
Conclusion: The updated results are consistent with previous studies.
Atelizumab + chemotherapy compared with placebo + chemotherapy did not significantly improve the patient's OS.
Different platinum drugs may affect the prognosis of atilizumab plus chemotherapy.
The safety of atilizumab + chemotherapy is consistent with the safety of each single agent.
References: 1.
CT040-Updated overall survival (OS) analysis of atezolizumab (atezo) monotherapy vs chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (mUC) in IMvigor1302.
CT042-Atezolizumab (atezo) + platinum/gemcitabine (plt/gem ) vs placebo + plt/gem in patients (pts) with previously untreated locally advanced or metastatic urothelial carcinoma (mUC): Updated overall survival (OS) from the randomized phase III study IMvigor130
This annual conference covers the most cutting-edge research results in the field of tumor research.
In the clinical research seminar, the IMvigor130 study announced the results of two studies.
CT040: Immune single agent vs placebo + chemotherapy Background: The preliminary analysis of Phase III IMvigor130 showed that atilizumab (group B) was compared with 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.
Exploratory subgroup analysis showed that compared with group C, the median OS of PD-L1 IC2/3 patients in group B was better, and the median OS of group B and group C were 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.
CT042: Immune combination vs placebo + chemotherapy Background: A preliminary study of IMvigor130 shows that compared with placebo + chemotherapy, atilizumab + chemotherapy can significantly improve the PFS of patients with metastatic urothelial cancer, and can improve it to a certain extent Patient OS (the first interim analysis showed that a significant difference was not reached).
This meeting reported the results of the second mid-term OS of group A versus group C.
Methods: The patients were randomly assigned to group A (atelizumab + chemotherapy), group B and group C at a ratio of 1:1:1.
The common primary endpoints were PFS and OS (group A vs.
C, ITT), OS (group B vs.
C, ITT, IC2/3), and secondary endpoints included objective response rate (ORR) and DoR.
Results: As of June 14, 2020, the median follow-up time was 13.
3 months.
In the ITT population, the median OS of group A and group C were 16.
1 months and 13.
4 months, respectively (HR=0.
84, P=0.
026) (not reaching the preset critical value of significant difference P=0.
014).
The median OS of groups A and C who received cisplatin was 21.
6 months and 14.
6 months, respectively, and the median OS of groups A and C who received carboplatin were 14.
3 months and 13 months, respectively. The ORRs of group A and group C were 48% and 45%, respectively, and 7% and 24% of patients in group A and C received immunotherapy outside the study plan.
Table OS interim analysis results.
In the safety analysis, the incidence of grade 3/4 treatment-related adverse events in group A and group C were 81% and 80%, respectively.
No new grade 5 treatment-related adverse events occurred.
Conclusion: The updated results are consistent with previous studies.
Atelizumab + chemotherapy compared with placebo + chemotherapy did not significantly improve the patient's OS.
Different platinum drugs may affect the prognosis of atilizumab plus chemotherapy.
The safety of atilizumab + chemotherapy is consistent with the safety of each single agent.
References: 1.
CT040-Updated overall survival (OS) analysis of atezolizumab (atezo) monotherapy vs chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (mUC) in IMvigor1302.
CT042-Atezolizumab (atezo) + platinum/gemcitabine (plt/gem ) vs placebo + plt/gem in patients (pts) with previously untreated locally advanced or metastatic urothelial carcinoma (mUC): Updated overall survival (OS) from the randomized phase III study IMvigor130
