Table 2.
Clinical trials investigating the duration of ICIs.
| Trials | Cancer | Phase/Size | ICIs | Duration | Results |
|---|---|---|---|---|---|
| The Safe Stop trial (NL7293) (3) | Melanoma | N=200 | Anti-PD-1 | 1 year Until CR or PR |
NR NR |
| CheckMate153 (NCT02066636) (11) | NSCLC | III (N=1434) | Nivolumab | Until progression, unacceptable toxicity, or withdrawal of informed consent 1-year-fixed duration |
PFS: 24.7m OS: NR PFS: 9.4m OS: 32.5m |
| CheckMate067 (NCT01844505) (12) | Melanoma | III (N=1296) | Nivolumab and Ipilimumab Nivolumab Ipilimumab |
Until progression, unacceptable toxicity, or withdrawal of informed consent | OS: NR 3-year OS: 58% OS: 37.6m 3-year OS: 52% OS:19.9m 3-year OS: 34% |
| KEYNOTE-024 (NCT02142738) (38) | NSCLC | III (N=305) | Pembrolizumab | 2 years | PFS:10.3m OS:26.3m 5-year OS: 31.9% |
| KEYNOTE-042 (NCT03850444) (38) | NSCLC | III (N=262) | Pembrolizumab | 2 years | PFS: 5.4m OS: 16.7m |
| KEYNOTE-189 (NCT03950674) (38) | NSCLC | III (N=40) | Pembrolizumab | 2 years | PFS: 9.0m OS: 22m ORR: 85.7% |
| KEYNOTE-407 (NCT03875092) (38) | NSCLC | III (N=125) | Pembrolizumab | 2 years | PFS: 6.4m OS: 15.9m |
| IMpower110 (NCT02409342) (38) | NSCLC | III (N=572) | Atezolizumab | Until progression, unacceptable toxicity, or death (maximum up to approximately 58 months) | PFS: 5.7m OS: 20.2m |
| IMpower130 (NCT02367781) (38) | NSCLC | III (N=723) | Atezolizumab | Until progression | PFS: 7.0m OS: 18.6m |
| IMpower150 (NCT02366143) (38) | NSCLC | III (N=1202) | Atezolizumab | Until progression | PFS: 8.3m OS: 19.8m |
| CheckMate227 (NCT02477826) (38) | NSCLC | III (N=2748) | Nivolumab and Ipilimumab | Until progression, unacceptable toxicity, or for 2 years | PFS: 5.1m OS: 17.1m |
| CheckMate9LA (NCT03215706) (38) | NSCLC | III (N=719) | Nivolumab and Ipilimumab | Until progression, unacceptable toxicity, or for 2 years | OS: 15.6m |
| PACIFIC (NCT04230408) (40) |
NSCLC | III (N=48) | Durvalumab | 1 year | PFS: 16.9m OS: 47.5m |
| GEMSTONE-301 (41) | NSCLC | III (N=381) | Sugemalimab | 2 years | PFS: 9.0m |
| CheckMate816 (NCT02998528) (42) | NSCLC | III (N=505) | Neoadjuvant Nivolumab | Until surgery | EFS: 31.6m |
| IMpower010 (NCT02486718) (43) | NSCLC | III (N=1280) | Atezolizumab | 1 year | HR for DFS: 0.81 (0·67-0·99; p=0·040) |
| NCT0267397 (44) | Melanoma | N=200 | Pembrolizumab or Nivolumab | 1 year | ORR: 96% |
| The DANTE trial (ISRCTN15837212) (45) | Melanoma | III (N=1208) | Anti-PD-1 | Until progression, unacceptable toxicity, or for 2 years | NR |
| KEYNOTE-001 (NCT01295827) (46) | NSCLC | I (N=550) | Pembrolizumab | Until progression, unacceptable toxicity, or for 2 years | OS: 22.3m 5-year OS: 29.6% |
| CA209-003 (NCT00730639) (47) | NSCLC | I (N=395) | Nivolumab | Until progression, unacceptable toxicity, confirmed CR, or for 2 years | 5-year OS: 16% |
| Mäkelä et al. (48) | Melanoma | N=40 | Anti-PD-1 | 6 months | PFS: 12m OS: NR |
| KEYNOTE-006 (NCT01866319) (49) | Melanoma | III (N=834) | Pembrolizumab Ipilimumab |
2 years | PFS: 8.4m OS: 32.7m PFS: 3.4m OS: 15.9m |
| KEYNOTE-010 (NCT01905657) (50) |
NSCLC | II/III (N=1034) | Pembrolizumab | 2 years | 3-year OS: 83.0% 5-year OS: 25.0% |
| NCT01693562 (51) | Various | I/II (N=1022) | Durvalumab | Retreatment after 1 year | PFS: 5.9m OS: 23.8m |
ICIs, immune checkpoint inhibitors; m, months; NSCLC, non-small cell lung cancer; NR, not reached; N, number; PFS, progression-free survival; OS, overall survival; ORR, overall response rate; EFS, event-free survival; DFS, disease-free survival; HR, hazard ratio.