Efficacy
The efficacy outcomes of CheckMate 214 have previously been reported in primary, second and third interim analyses.rrr
After a minimum of 5 years follow up (median follow up 67.7 months), OS superiority was maintained with nivolumab plus ipilimumab compared to sunitinib in the intention to treat (ITT) population (HR, 0.72; 95% CI, 0.62-0.85, P<0.0001) and in the intermediate-risk/poor-risk population (HR 0.68, 95% CI, 0.58-0.81, P<0.0001). OS benefits were observed with nivolumab plus ipilimumab compared to sunitinib in ITT patients regardless of PD-L1 expression status. PFS and ORR benefits were also maintained in the ITT and intermediate-risk/poor risk patient group.r The results are summarised in the table below.
Importantly, more responses to nivolumab plus ipilimumab were complete (11.6%) and durable (63% ongoing response) compared to sunitinib (3.1% complete response, 50.3% ongoing response) in the ITT population.r
Exploratory analysis in patients with favourable-risk disease showed improved outcomes in the sunitinib group compared to the nivolumab plus ipilimumab group, with prolonged median PFS (28.9 months vs 12.4 months, HR=1.6; 95% CI 1.13 to 2.26; p=0.0073) and higher ORR (51.6% vs 29.6%, p=0.0002). However, more responses in the nivolumab plus ipilimumab group were complete (12.8% vs 6.5%) and durable (59.5% vs 51.6%) compared to sunitinib.r Ongoing follow-up and data maturation for this patient subgroup is required before definitive conclusions can be made regarding optimal therapy.
Summary of co-primary endpoint analysis after a median follow up of 67.7 months in the ITT population and Intermediate/poor-risk disease patientsr
|
ITT population |
Intermediate-risk/poor-risk disease |
NIVO-IPI
n = 550 |
SUN
n = 546 |
NIVO-IPI
n = 425 |
SUN
n = 422 |
Median OS
(months) |
55.7 |
38.4 |
47 |
26.6 |
HR 0.72;
(95% CI, 0.62-0.85; P<0.0001 |
HR 0.68;
(95% CI, 0.38-0.81); P<0.0001 |
Median PFS
(months) |
12.3 |
12.3 |
11.6 |
8.3 |
HR 0.86;
(95% CI, 0.72-1.01); P=0.0628 |
HR 0.73;
(95% CI, 0.61-0.87); P=0.0004 |
ORR (%) |
39.3 |
32.4 |
42.1 |
26.8 |
P=0.0055 |
P<0.0001 |
Kaplan-Meier curve for overall survival in ITT populationr
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Kaplan-Meier curve for overall survival in intermediate-risk/poor-risk disease patientsr
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Kaplan-Meier curve for progression-free survival in ITT populationr
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Kaplan-Meier curve for progression-free survival in intermediate-risk/poor-risk patientsr
© Cancer 2022