TABLE 2.
Response, Disease Control, and PFS
| Outcome | LAG-3 ≥1% | LAG-3 <1% | All Randomly Assigned | |||
|---|---|---|---|---|---|---|
| NIVO + RELA + Chemo (n = 97) | NIVO + Chemo (n = 98) | NIVO + RELA + Chemo (n = 41) | NIVO + Chemo (n = 38) | NIVO + RELA + Chemo (n = 138) | NIVO + Chemo (n = 136) | |
| BICR-assessed | ||||||
| ORRa,b | ||||||
| No. (%) | 47 (48) | 60 (61) | 13 (32) | 21 (55) | 60 (43) | 81 (60) |
| [95% CI] | 38 to 59 | 51 to 71 | 18 to 48 | 38 to 71 | 35 to 52 | 51 to 68 |
| Difference of ORRc (70% CI) | –13 (–20 to –6) | –25 (–36 to –15) | –17 (–23 to –10) | |||
| Pd | .0711 | NA | NA | |||
| Best overall response,a No. (%) | ||||||
| CR | 6 (6) | 10 (10) | 2 (5) | 0 | 8 (6) | 10 (7) |
| PR | 41 (42) | 50 (51) | 11 (27) | 21 (55) | 52 (38) | 71 (52) |
| SD | 34 (35) | 18 (18) | 11 (27) | 7 (18) | 45 (33) | 25 (18) |
| PD | 1 (1) | 10 (10) | 2 (5) | 4 (11) | 3 (2) | 14 (10) |
| Unable to determine | 7 (7) | 5 (5) | 7 (17) | 0 | 14 (10) | 5 (4) |
| DCRa | ||||||
| No. (%) | 89 (92) | 83 (85) | 32 (78) | 34 (89) | 121 (88) | 117 (86) |
| 95% CI | 84 to 96 | 76 to 91 | 62 to 89 | 75 to 97 | 81 to 93 | 79 to 91 |
| TTR, months,e median (range) | 1.5 (1.2-5.3) | 1.5 (1.2-5.6) | 1.6 (1.3-4.0) | 2.8 (1.2-7.2) | 1.5 (1.2-5.3) | 2.0 (1.2-7.2) |
| DOR, months,e median (95% CI) | 5.7 (4.4 to 10.0) | 10.1 (6.4 to 13.3) | 5.4 (3.3 to 7.0) | 8.5 (5.3 to 13.6) | 5.6 (5.1 to 7.0) | 9.7 (6.7 to 12.5) |
| PFS, months, median (95% CI) | 7.0 (5.8 to 8.4) | 8.3 (6.9 to 12.1) | 6.6 (4.7 to 7.1) | 9.7 (6.9 to 13.7) | 6.8 (5.8 to 7.3) | 9.4 (7.0 to 11.5) |
| INV-assessed | ||||||
| ORRa,b | ||||||
| No. (%) | 51 (53) | 55 (56) | 13 (32) | 16 (42) | 64 (46) | 71 (52) |
| 95% CI | 42 to 63 | 46 to 66 | 18 to 48 | 26 to 59 | 38 to 55 | 43.5 to 61 |
| Best overall response,a No. (%) | ||||||
| CR | 3 (3) | 5 (5) | 0 | 0 | 3 (2) | 5 (4) |
| PR | 48 (49) | 50 (51) | 13 (32) | 16 (42) | 61 (44) | 66 (49) |
| SD | 33 (34) | 27 (28) | 19 (46) | 18 (47) | 52 (38) | 45 (33) |
| PD | 6 (6) | 12 (12) | 2 (5) | 4 (11) | 8 (6) | 16 (12) |
| Unable to determine | 7 (7) | 4 (4) | 7 (17) | 0 | 14 (10) | 4 (3) |
| DCRa | ||||||
| No. (%) | 84 (87) | 82 (84) | 32 (78) | 34 (89) | 116 (84) | 116 (85) |
| 95% CI | 78 to 93 | 75 to 90 | 62 to 89 | 75 to 97 | 77 to 90 | 78 to 91 |
| TTR, months,f median (range) | 1.6 (0.9-5.5) | 1.4 (1.2-8.5) | 1.5 (1.2-4.1) | 2.3 (1.0-16.6) | 1.6 (0.9-5.5) | 1.5 (1.0-16.6) |
| DOR, months,f median (95% CI) | 6.9 (4.4 to 8.3) | 8.3 (6.9 to 12.45) | 5.5 (3.0 to 6.9) | 7.5 (5.6 to 13.6) | 5.9 (4.4 to 7.3) | 8.3 (6.9 to 11.1) |
| PFS, months, median (95% CI) | 7.0 (5.8 to 8.4) | 8.3 (5.9 to 9.7) | 5.4 (4.2 to 7.6) | 11.0 (6.9 to 13.7) | 6.6 (5.4 to 7.6) | 8.3 (6.9 to 9.7) |
Abbreviations: BICR, blinded independent central review; chemo, chemotherapy; CR, complete response; DCR, disease control rate; DOR, duration of response; INV, investigator; LAG-3, lymphocyte-activation gene 3; NA, not applicable; NIVO, nivolumab; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; RELA, relatlimab; SD, stable disease; TTR, time to response.
Per RECIST 1.1.
CI on the basis of the Clopper-Pearson method.
Strata adjusted difference in ORR (NIVO + RELA + chemo over NIVO + chemo) on the basis of the Cochran-Mantel-Haenszel method of weighting.
On the basis of two-sided stratified Cochran-Mantel-Haenszel test.
Number of responders: LAG-3 ≥1%, NIVO + RELA + chemo (n = 47) and NIVO + chemo (n = 60); LAG-3 <1%, NIVO + RELA + chemo (n = 13) and NIVO + chemo (n = 21); all randomly assigned NIVO + RELA + chemo (n = 60) and NIVO + chemo (n = 81).
Number of responders: LAG-3 ≥1%, NIVO + RELA + chemo (n = 51) and NIVO + chemo (n = 55); LAG-3 <1%, NIVO + RELA + chemo (n = 13) and NIVO + chemo (n = 16); all randomly assigned NIVO + RELA + chemo (n = 64) and NIVO + chemo (n = 71).