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Clin Cancer Res: The efficacy of standard-dose Pembrolizumab combined with different doses of Ipilimumab in the treatment of advanced melanoma: KEYNOTE-029 cohort 1C.

 Last Update: 2021-08-02
 Source: Internet
 Author: User

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The results of the Phase I clinical study KEYNOTE-029 cohort B showed that the standard dose of Pembrolizumab combined with Ipilimumab (1 mg/kg Q3W in 4 doses) is tolerable and has strong anti-tumor activity in advanced melanoma

Previously untreated patients with III/IV melanoma were randomly assigned to the standard dose of Pembrolizumab 200 mg Q3W ≤24 months combined with ipilimumab 50 mg Q6W, 4 cycles (PEM200+IPI50) , or Pembrolizumab 200 mg Q3W ≤24 months Combined with ipilimumab 100 mg Q12W, 4 cycles (PEM200+IPI100)

The median follow-up time of PEM200+IPI50 (N=51) group was 16.

The ORRs of the two groups were 55% (28/51 patients; 95% CI, 40% to 69%) and 61% (31/51 patients; 95% CI, 46% to 74%)

ORR

During the data analysis, 4 (14%) of 28 responders in the PEM200+IPI50 group progressed, while 2 (6%) of the 31 responders in the PEM200+IPI100 group progressed

The median sustained remission time of the two groups was not reached, and the 12-month still-response rates evaluated were 88% and 93%, respectively

DoR

The median PFS in both groups was not reached

PFS

The median OS of the same two groups was not reached
.
The 12-month OS rates were 94% (95% CI, 83% to 98%) and 90% (95% CI, 78% to 96%); the 18-month OS rates were 85% (95% CI , 70% to 92%) and 82% (95% CI, 67% to 91%)
.
The median OS of the same two groups was not reached
.
The 12-month OS rates were 94% (95% CI, 83% to 98%) and 90% (95% CI, 78% to 96%); the 18-month OS rates were 85% (95% CI , 70% to 92%) and 82% (95% CI, 67% to 91%)
.

In summary, according to the threshold set before the study, the standard dose of Pembrolizumab 200 mg Q3W combined with ipilimumab 50 mg Q6W or 100 mg Q12W showed good anti-tumor activity
.
Pembrolizumab combined with ipilimumab 50 mg Q6W has lower grade 3-5 TRAEs, indicating a decrease in toxicity
.
According to the threshold set before the study, the standard dose of Pembrolizumab 200 mg Q3W combined with ipilimumab 50 mg Q6W or 100 mg Q12W showed good anti-tumor activity
.
Pembrolizumab combined with ipilimumab 50 mg Q6W has lower grade 3-5 TRAEs, indicating a decrease in toxicity
.
According to the threshold set before the study, the standard dose of Pembrolizumab 200 mg Q3W combined with ipilimumab 50 mg Q6W or 100 mg Q12W showed good anti-tumor activity
.
Pembrolizumab combined with ipilimumab 50 mg Q6W has lower grade 3-5 TRAEs, indicating a decrease in toxicity
.

Original source:

Long GV, Robert C, Butler MO, et al.
Standard-Dose Pembrolizumab Plus Alternate-Dose Ipilimumab in Advanced Melanoma: KEYNOTE-029 Cohort 1C, a Phase 2 Randomized Study of Two Dosing Schedules.
Clin Cancer Res.
2021 Jul 1:clincanres .
0793.
2021.
doi: 10.
1158/1078-0432.
CCR-21-0793.
Epub ahead of print.
PMID: 34210681.

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