TABLE 2

Activity, efficacy and toxicity outcomes reported in trials evaluating immune checkpoint inhibitors in small cell lung cancer

TrialNDrugsORRMedian PFS
HR (95% CI)
Median OS
HR (95% CI)
Grade ≥3 AE (%)
First line
 IMpower133 [4, 83]403Atezolizumab+CT versus Placebo+CT60% versus 64%5.2 versus 4.3 months
0.77 (0.62–0.96)
12.3 versus 10.3 months
0.76 (0.60–0.95)
68.2 versus 64.8
 CASPIAN [5, 6]537Durvalumab+CT versus CT67.9% versus 57.6%5.1 versus 5.4 months
0.78 (0.64–0.93)
13 versus 10.3 months
0.73 (0.59–0.90)
64.6 versus 63.6
 KEYNOTE-604 [82]453Pembrolizumab+CT versus Placebo+CT70.6% versus 61.8%4.8 versus 4.3 months
0.75 (0.61–0.91)
10.8 versus 9.7 months
0.80 (0.64–0.98)#
79.4 versus 77.6
 ECOG-ACRIN EA516 [84]160Nivolumab+CT versus CT52% versus 47%5.5 versus 4.6 months
0.65 (0.46–0.91)
11.3 versus 8.5 months
0.67 (0.46–0.98)
77 versus 62
Maintenance
 CheckMate 451 [85]834Nivolumab+Ipilimumab versus PlaceboNR1.7 versus 1.4 months
0.72 (0.6–0.87)
9.2 versus 9.6 months
0.92 (0.75–1.12)
54 versus 8
NCT02359019 [86]45Pembrolizumab11.1%1.4 months9.6 monthsNA
≥Second line
 CheckMate 33 [87]569Nivolumab versus CT14% versus 17%1.4 versus 3.8 months
1.41 (1.18–1.69)
7.5 versus 8.4 months
0.86 (0.72–1.04)
15 versus 74
 IFCT-1603 [88]73Atezolizumab versus CT2.3 versus 10%1.4 versus 4.3 months
2.26 (1.3–3.93)
9.5 versus 8.7 months
0.84 (0.45–1.58)
NA
 PCD4989 g [89]17Atezolizumab17.6%2.9 months5.9 months29.4
 KEYNOTE-158 [90]
≥third line
107Pembrolizumab18.7%2 months9.1 months12
 KEYNOTE-028 [91]24Pembrolizumab33.3%1.9 months9.7 months8.3
 CheckMate 032 [92]
(non-randomised cohort)
98Nivolumab
Nivolumab+Ipilimumab
11%
23%
NR
NR
4.1 months
6 months
NA
 CheckMate 032 [93]
(randomised cohort) nivolumab≥third line
147
96
Nivolumab versus Nivolumab+Ipilimumab11.6% versus 21.9%1.4 months
1.5 months
5.7 months
4.7 months
1.05 (0.74–1.47)
12.9 versus 37.5
 BALTIC [94]21Durvalumab+Tremelimumab9.5%1.9 months6 months48

N: Number of patients; ORR: Objective response rate; PFS: Progression-free survival; HR: Hazard ratio; 95% CI: 95% confidence interval; OS: Overall survival; AE: adverse events; CT: Chemotherapy; NR: Not reported; NA: Not available. #: Statistically non-significant; : according to immune-related response criteria (irRC).