Efficacy
With a minimum follow-up of 36.1 months, the median OS was 15.8 months (95% CI, 13.9–19.7) in the nivolumab and ipilimumab plus chemotherapy group compared to 11.0 months (95% CI: 9.5–12.7) in the chemotherapy-alone group (HR 0.74; 95% CI, 0.62–0.87). The 3-year OS rates were 27% vs. 19%, respectively.4
Improved OS in the nivolumab and ipilimumab plus chemotherapy group compared to the chemotherapy-alone group was demonstrated across most key subgroups, including PD-L1 expression and squamous or non-squamous subtypes.4
Subgroup analysis of median OS4
Subgroup |
Nivolumab + ipilimumab + chemotherapy
(n=361) |
Chemotherapy
(n=358) |
Squamous, months (95% CI)
(n=227) |
14.5 (13.1–19.3) |
9.1 (7.2–11.6) |
HR 0.64 (95% CI, 0.48–0.86) |
Non-squamous, months (95% CI)
(n=492) |
17.8 (14.1–20.7) |
12.0 (9.9–13.9) |
HR 0.80 (95% CI, 0.65–0.98) |
PD-L1 <1%, months (95% CI)
(n= 264) |
17.7 (13.7–20.3) |
9.8 (7.7−13.5) |
HR 0.67 (95% CI, 0.51−0.88) |
PD-L1 ≥1%, months (95% CI)
(n=408) |
15.8 (13.8−22.2) |
10.9 (9.5−13.2) |
HR 0.74 (95% CI, 0.60−0.93) |
PD-L1 1%–49%, months (95% CI)
(n=234) |
15.2 (12.6−21.2) |
10.4 (8.7−12.4) |
HR 0.70 (95% CI, 0.53−0.93) |
PD-L1 ≥50% (months (95% CI)
(n=174) |
18.9 (13.1−29.1 |
12.9 (9.4−17.6) |
HR 0.75 (95% CI, 0.53−1.07) |
Abbreviations: HR - Hazard ratio; PD-L1 - programmed death-ligand 1
Kaplan-Meier estimates for OS in A) All randomised patients, and in patients with tumour PD-L1 B) <1%, C) ≥1%, D) 1%–49%, and E) ≥50%4


© J Thorac Oncol 2023
Summary of secondary endpoints analysis4
Secondary endpoint |
Nivolumab + ipilimumab + chemotherapy |
Chemotherapy |
Median PFS (months, 95% CI) in overall cohort |
6.4 (5.5 to 7.8) |
5.3 (4.4 to 5.6) |
HR=0.70 (95% CI, 0.59 to 0.83) |
Median PFS (months, 95% CI) in patients who were alive at 3 years |
35.9 (27.7 to 42.4) |
16.7 (11.4–19.3) |
HR=0.56 (95% CI, 0.36 to 0.85) |
ORR (%, 95% CI) in overall cohort |
38 (32.9 to 43.2) |
25 (20.7 to 30.0) |
ORR (%, 95% CI) in patients who were alive at 3 years |
69 (58.5 to 77.8) |
57 (44.0 to 69.5) |
Median DoR (months, 95% CI) in overall cohort |
12.4 (8.7 to 20.1) |
5.6 (4.4 to 7.2) |
Median DoR (months, 95% CI) in patients who were alive at 3 years |
34.7 (31.5 to NR) |
12.2 (9.6 to NR) |
Abbreviations: DoR - duration of response; NR - not reached.