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The 2021 American Society of Clinical Oncology (ASCO) annual meeting will be held online from June 4th to 8th.
As one of the largest and most popular events in oncology, the ASCO annual meeting will showcase the latest cutting-edge developments to scholars from all walks of life
.
This year's ASCO conference oral report special, in the field of kidney cancer, KEYNOTE-426 announced the results of a long-term follow-up of 42.
8 months
.
Background: KEYNOTE-426 (NCT02853331) is a phase III open-label, multi-center, randomized controlled phase III clinical study
.
In the first interim analysis, compared with sunitinib, pembrolizumab + axitinib can significantly improve the overall survival (OS) and progression-free of patients with newly diagnosed advanced clear cell renal cell carcinoma (ccRCC) Survival period (PFS) and objective response rate (ORR)
.
Further follow-up results show that the combined program still has a better effect in this kind of population
.
At this ASCO conference, the researchers announced a final analysis of 42.
8 months
.
Methods: KPS≥70%, measurable lesions (assessed according to the RECIST v1.
1 standard) newly treated advanced ccRCC were randomly assigned to receive pembrolizumab (200 mg IV Q3W, up to 35 doses) + axitinib at 1:1 (5 mg oral BID) or sunitinib (50 mg oral QD, continuous use for 4 weeks, stop for 2 weeks) until the disease progresses, or unacceptable toxicity occurs or the study is withdrawn
.
Stratification factors include IMDC risk classification (low risk vs medium risk vs high risk), geographic region (North America vs Western Europe vs other regions)
.
The common primary endpoints were OS and PFS, and the secondary endpoints were ORR, duration of remission (DOR), and safety
.
At the time of the final analysis, 404 OS events had occurred
.
Study design results: Overall, 861 patients with advanced ccRCC were randomly assigned to receive pembrolizumab + axitinib (n=432) or sunitinib (n=429)
.
The median follow-up time was defined as the time from randomization to the cut-off of data analysis
.
The median follow-up time was 42.
8 months (range: 35.
6-50.
6), 418 patients died, 44.
7% (193/432) and 52.
4% (225/429) in the pembrolizumab group and sunitinib group, respectively The patient died
.
Compared with sunitinib, pembrolizumab + axitinib can significantly improve the patient’s OS and PFS.
The median OS of pembrolizumab group and sunitinib group were 45.
7 months and 40.
1, respectively Months (HR=0.
73 [95% CI, 0.
60-0.
88]; P<0.
001), the 42-month OS rates of the two groups were 57.
5% and 48.
5% of ITT population OS results Pembrolizumab group and sunitinib The median PFS of the two groups were 15.
7 months and 11.
1 months, respectively (HR=0.
68 [95% CI, 0.
58-0.
80]; P<0.
0001), and the 42-month PFS rates of the two groups were 25.
1% and 10.
6% of the ITT population, respectively PFS results The ORR rates of the two groups were 60.
4% and 39.
6% (P<0.
0001), the complete remission (CR) rates of the two groups were 10.
0% and 3.
5%, respectively, and the median DOR of the two groups were 23.
6 months (range : 1.
4+ to 43.
4+) and 15.
3 months (range: 2.
3-42.
8+)
.
ITT population ORR results, DOR analysis, subgroup analysis results, 58.
4% and 73% of patients in the pembrolizumab group and sunitinib group received follow-up anti-tumor therapy
.
In the follow-up anti-tumor treatment, a considerable proportion of patients in the two groups received VEGF/VEGFR inhibitor treatment, but the subsequent PD-1/PD-L1 inhibitors received different proportions.
Only 21.
6% of patients in the pembrolizumab group received PD -1/PD-L1 inhibitor treatment, while 74.
4% of the sunitinib group received PD-1/PD-L1 inhibitor treatment
.
No new security incidents were found
.
The two groups of patients received follow-up anti-tumor treatment.
Conclusion: The median follow-up of 42.
8 months is the longest follow-up time of PD-1/PD-L1 inhibitor + VEGF/VEGFR inhibitor in the first-line treatment of renal cancer patients
.
The results showed that pembrolizumab + axitinib still showed efficacy advantages in PFS, OS, and ORR compared with sunitinib, and no new safety events were found
.
Clinical trial information: NCT02853331
.
Reference: Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426.
abstract 4500.
Oral Abstract Session
As one of the largest and most popular events in oncology, the ASCO annual meeting will showcase the latest cutting-edge developments to scholars from all walks of life
.
This year's ASCO conference oral report special, in the field of kidney cancer, KEYNOTE-426 announced the results of a long-term follow-up of 42.
8 months
.
Background: KEYNOTE-426 (NCT02853331) is a phase III open-label, multi-center, randomized controlled phase III clinical study
.
In the first interim analysis, compared with sunitinib, pembrolizumab + axitinib can significantly improve the overall survival (OS) and progression-free of patients with newly diagnosed advanced clear cell renal cell carcinoma (ccRCC) Survival period (PFS) and objective response rate (ORR)
.
Further follow-up results show that the combined program still has a better effect in this kind of population
.
At this ASCO conference, the researchers announced a final analysis of 42.
8 months
.
Methods: KPS≥70%, measurable lesions (assessed according to the RECIST v1.
1 standard) newly treated advanced ccRCC were randomly assigned to receive pembrolizumab (200 mg IV Q3W, up to 35 doses) + axitinib at 1:1 (5 mg oral BID) or sunitinib (50 mg oral QD, continuous use for 4 weeks, stop for 2 weeks) until the disease progresses, or unacceptable toxicity occurs or the study is withdrawn
.
Stratification factors include IMDC risk classification (low risk vs medium risk vs high risk), geographic region (North America vs Western Europe vs other regions)
.
The common primary endpoints were OS and PFS, and the secondary endpoints were ORR, duration of remission (DOR), and safety
.
At the time of the final analysis, 404 OS events had occurred
.
Study design results: Overall, 861 patients with advanced ccRCC were randomly assigned to receive pembrolizumab + axitinib (n=432) or sunitinib (n=429)
.
The median follow-up time was defined as the time from randomization to the cut-off of data analysis
.
The median follow-up time was 42.
8 months (range: 35.
6-50.
6), 418 patients died, 44.
7% (193/432) and 52.
4% (225/429) in the pembrolizumab group and sunitinib group, respectively The patient died
.
Compared with sunitinib, pembrolizumab + axitinib can significantly improve the patient’s OS and PFS.
The median OS of pembrolizumab group and sunitinib group were 45.
7 months and 40.
1, respectively Months (HR=0.
73 [95% CI, 0.
60-0.
88]; P<0.
001), the 42-month OS rates of the two groups were 57.
5% and 48.
5% of ITT population OS results Pembrolizumab group and sunitinib The median PFS of the two groups were 15.
7 months and 11.
1 months, respectively (HR=0.
68 [95% CI, 0.
58-0.
80]; P<0.
0001), and the 42-month PFS rates of the two groups were 25.
1% and 10.
6% of the ITT population, respectively PFS results The ORR rates of the two groups were 60.
4% and 39.
6% (P<0.
0001), the complete remission (CR) rates of the two groups were 10.
0% and 3.
5%, respectively, and the median DOR of the two groups were 23.
6 months (range : 1.
4+ to 43.
4+) and 15.
3 months (range: 2.
3-42.
8+)
.
ITT population ORR results, DOR analysis, subgroup analysis results, 58.
4% and 73% of patients in the pembrolizumab group and sunitinib group received follow-up anti-tumor therapy
.
In the follow-up anti-tumor treatment, a considerable proportion of patients in the two groups received VEGF/VEGFR inhibitor treatment, but the subsequent PD-1/PD-L1 inhibitors received different proportions.
Only 21.
6% of patients in the pembrolizumab group received PD -1/PD-L1 inhibitor treatment, while 74.
4% of the sunitinib group received PD-1/PD-L1 inhibitor treatment
.
No new security incidents were found
.
The two groups of patients received follow-up anti-tumor treatment.
Conclusion: The median follow-up of 42.
8 months is the longest follow-up time of PD-1/PD-L1 inhibitor + VEGF/VEGFR inhibitor in the first-line treatment of renal cancer patients
.
The results showed that pembrolizumab + axitinib still showed efficacy advantages in PFS, OS, and ORR compared with sunitinib, and no new safety events were found
.
Clinical trial information: NCT02853331
.
Reference: Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426.
abstract 4500.
Oral Abstract Session
