Table 1.
Characteristics of the trials included in this study.
| Study | Trial design | Tumor type | No. of patients (enrolled) | Median age (years, range) | Sex (M/F) | No. of patients (safety) | Treatment | Median treatment time (months, range) | Median follow up (months, range) | Median OS (months, 95% CI) | FAE |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CheckMate 0579 | Open-label, phase III RCT | Lung cancer | 292 | 61(37–84) | 151/141 | 287 | Nivolumab 3 mg/kg every 14 days | 3.0(0.5–26.0) | >13.2 | 12.2(9.7–15.0) | 1 |
| 290 | 64(21–85) | 168/122 | 268 | Docetaxel 75 mg/m2 every 21 days | 3.0(0.8–17.3) | 9.4(8.1–10.7) | 1 | ||||
| CheckMate 01710 | Open-label, phase III RCT | Lung cancer | 135 | 62(39–85) | 111/24 | 131 | Nivolumab 3 mg/kg every 14 days | 4.0(0.5–24.0) | <11.0 | 9.2(7.3–13.3) | 0 |
| 137 | 64(42–84) | 97/40 | 129 | Docetaxel 75 mg/m2 every 21 days | 2.3(0.8–21.8) | 6.0(5.1–7.3) | 3 | ||||
| CheckMate 02611 | Open-label, phase III RCT | Lung cancer | 271 | 63(32–89) | 184/87 | 267 | Nivolumab 3 mg/kg every 14 days | 3.7(0.0–26.9) | 13.5 | 14.4(11.7–17.4) | 2 |
| 270 | 65(29–87) | 148/122 | 263 | ICC once every 21 days | 3.4(0.0–20.9) | 13.2(10.7–17.1) | 3 | ||||
| CheckMate 14113 | Open-label, phase III RCT | Head and neck cancer | 240 | 59(29–83) | 197/43 | 236 | Nivolumab 3 mg/kg every 14 days | 1.9 | 5.1(0–16.8) | 7.5(5.5–9.1) | 2 |
| 121 | 61(28–78) | 103/18 | 111 | Standard therapy | 1.9 | 5.1(4.0–6.0) | 1 | ||||
| ATTRACTION-212 | Double-blind, phase III RCT | G/GJC | 330 | 62(54–69) | 229/101 | 330 | Nivolumab 3 mg/kg every 14 days | 1.9 | 8.9 | 5.3(4.6–6.4) | 5 |
| 163 | 61(53–68) | 119/44 | 161 | Placebo 3 mg/kg every 14 days | 1.9 | 8.6 | 4.1(3.4–4.9) | 2 | |||
| CheckMate 02514 | Open-label, phase III RCT | Renal cancer | 410 | 62(23–88) | 315/95 | 406 | Nivolumab 3 mg/kg every 14 days | 5.5(0–29.6) | >14.0 | 25.0(21.8–NR) | 0 |
| 411 | 62(18–86) | 304/107 | 397 | Everolimus 10 mg daily | 3.7(0.2–25.7) | 19.6(17.6–23.1) | 2 | ||||
| CheckMate 06615 | Double-blind, phase III RCT | Melanoma | 210 | 64(18–86) | 121/89 | 206 | Nivolumab 3 mg/kg every 14 days | NR | <16.7 | Not reached | 0 |
| 205 | 66(26–87) | 125/83 | 205 | Docetaxel 1000 mg/m2 every 21 days | 10.8(9.3–12.1) | 0 | |||||
| CheckMate 23826 | Double-blind, phase III RCT | Melanoma | 453 | 56(19–83) | 258/195 | 452 | Nivolumab 3 mg/kg every 14 days | 12.0 | >18.0 | NR | 0 |
| 453 | 54(18–86) | 269/184 | 453 | Ipilimumab 10 mg/kg every 21 days | 3.0 | 2 | |||||
| CheckMate 06727 | Double-blind, phase III RCT | Melanoma | 316 | 60(25–90) | 202/114 | 313 | Nivolumab 3 mg/kg every 14 days | 7.5 | 35.7 | 37.6(29.1–NR) | 1 |
| 315 | 62(18–89) | 202/113 | 311 | Ipilimumab 3 mg/kg every 21 days | 3.0 | 18.6 | 19.9(16.9–24.6) | 1 | |||
| CheckMate 03728,29 | Open-label, phase III RCT | Melanoma | 272 | 59(23–88) | 176/96 | 268 | Nivolumab 3 mg/kg every 14 days | 5.3 | 8.4 | 15.7(12.9–19.9) | 0 |
| 133 | 62(29–85) | 85/48 | 102 | ICC | 2.0 | 14.4(11.7–18.2) | 0 | ||||
| POPLAR30 | Open-label, phase II RCT | Lung cancer | 144 | 62(42–82) | 93/51 | 142 | Atezolizumab 1200 mg every 21 days | 3.7(0–19) | 14.8(0.2–19.6) | 12.6(9.7–16.4) | 1 |
| 143 | 62(36–84) | 76/67 | 135 | Docetaxel 75 mg/m2 every 21 days | 2.1(0–17) | 15.7(0.1–18.7) | 9.7(8.6–12.0) | 3 | |||
| IMvigor21131 | Open-label, phase III RCT | Urothelial cancer | 467 | 67(33–88) | 357/100 | 459 | Atezolizumab 1200 mg every 21 days | 2.8(0–24.0) | 17.3(0–24.5) | 11.1(8.6–15.5) | 4 |
| 464 | 67(31/84) | 361/103 | 443 | ICC once every 21 days | 2.1(0–23.0) | 10.6(8.4–12.2) | 9 | ||||
| OAK32 | Open-label, phase III RCT | Lung cancer | 425 | 63(33–82) | 261/164 | 609 | Atezolizumab 1200 mg every 21 days | 3.4(0–26.0) | 21 | 13.8(11.8–15.7) | 0 |
| 425 | 64(34–85) | 259/166 | 578 | Docetaxel 75 mg/m2 every 21 days | 2.1(0–23.0) | 9.6(8.6–11.2) | 1 | ||||
| KEYNOTE-04533 | Open-label, phase III RCT | Urothelial cancer | 270 | 67(29–88) | 200/70 | 266 | Pembrolizumab 200 mg every 21 days | 3.5(0–20.0) | 14.1(9.9–22.1) | 10.3(8.0–11.8) | 1 |
| 272 | 65(26–84) | 202/70 | 255 | ICC once every 21 days | 1.5(0–14.2) | 7.4(6.1–8.3) | 4 | ||||
| KEYNOTE-05434 | Double-blind, phase III RCT | Melanoma | 514 | 54(19–88) | 324/190 | 509 | Pembrolizumab 200 mg every 21 days | 13.5 | 14.7 | NR | 1 |
| 505 | 54(19–83) | 304/201 | 502 | Placebo 200 mg every 21 days | 13.5 | 15.4 | 0 | ||||
| KEYNOTE-01035 | Open-label, phase II/III RCT | Lung cancer | 344 | 63(56–69) | 212/132 | 339 | Pembrolizumab 2 mg/kg every 21 days | 3.5 | 13.1 | 10.4(9.4–11.9) | 3 |
| 346 | 63(56–69) | 213/133 | 343 | Pembrolizumab 10 mg/kg every 21 days | 3.5 | 12.7(10.0–17.3) | 3 | ||||
| 343 | 62(56–69) | 209/134 | 309 | Docetaxel 75 mg/m2 every 21 days | 2.0 | 8.5(7.5–9.8) | 5 | ||||
| KEYNOTE-06136 | Open-label, phase III RCT | G/GJC | 296 | 63(54–70) | 202/94 | 294 | Pembrolizumab 200 mg every 21 days | 4.4 | 7.9 | 9.1(6.2–10.7) | 3 |
| 296 | 60(53–68) | 208/88 | 276 | Paclitaxel 80 mg/m2 on day 1,8,15 every 28 days | 3.5 | 8.3(7.6–9.0) | 1 | ||||
| KEYNOTE-02437 | Open-label, phase III RCT | Lung cancer | 154 | 65(33–90) | 92/62 | 154 | Pembrolizumab 200 mg every 21 days | 7.0(0–18.7) | 11.2(6.3–19.7) | Not reached | 1 |
| 151 | 66(38–85) | 95/56 | 150 | Placebo 200 mg every 21 days | 3.5(0–16.8) | 3 | |||||
| KEYNOTE-00238 | Double-blind, phase II RCT | Melanoma | 180 | 62(15–87) | 104/76 | 178 | Pembrolizumab 2 mg/kg every 21 days | 3.8(0–16.6) | 10.0 | NR | 0 |
| 181 | 60(27–89) | 109/72 | 179 | Pembrolizumab 10 mg/kg every 21 days | 4.8(0–16.8) | 0 | |||||
| 179 | 63(27–87) | 114/165 | 171 | ICC | 2.0(0–11.2) | 0 | |||||
| KEYNOTE-00639 | Open-label, phase III RCT | Melanoma | 279 | 61(18–89) | 161/118 | 278 | Pembrolizumab 10 mg/kg every 14 days | 7.0(0–27.0) | 22.9 | Not reached | 1 |
| 277 | 63(22–89) | 174/103 | 277 | Pembrolizumab 10 mg/kg every 21 days | 6.0(0–27.8) | Not reached | 0 | ||||
| 278 | 62(18–88) | 162/116 | 256 | Ipilimumab 3 mg/kg every 21 days | 2.3(0–3.3) | 16.0(13.5–22.0) | 0 |
FAE, fatal adverse event; G/GJC, gastric or gastroesophageal junction cancer; ICC, investigator-choice chemotherapy; NR, not reported; OS, overall survival; RCT, randomized controlled trial.