Table 4.
Efficacy of Nivolumab Monotherapy by Baseline Tumor PD-L1 Expression*
| PD-L1 Expression, % | Confirmed ORR†, % (n/N) | Median DOR‡, Months (Range) | Ongoing Responders§, % | PFS at 24 Weeks||, % (95% CI) | Median PFS, Months (Range) | 1-Year OS, % (95% CI) | 18-Month OS, % (95% CI) |
|---|---|---|---|---|---|---|---|
| ≥ 50 | 50 (6/12) | NR (5.3+ to 25.8+) | 83 | 58 (27 to 80) | 8.3 (2.2 to 28.0+) | 83 (48 to 96) | 83 (48 to 96) |
| ≥ 25 | 44 (8/18) | NR (4.2 to 25.8+) | 75 | 50 (26 to 70) | 5.8 (0.2 to 28.0+) | 78 (51 to 91) | 71 (43 to 87) |
| ≥ 10 | 40 (8/20) | NR (4.2 to 25.8+) | 75 | 45 (23 to 65) | 5.2 (0.2 to 28.0+) | 80 (55 to 92) | 68 (41 to 84) |
| ≥ 5 | 31 (8/26) | NR (4.2 to 25.8+) | 75 | 40 (21 to 58) | 3.5 (< 0.1+ to 28.0+) | 73 (52 to 86) | 54 (32 to 71) |
| ≥ 1 | 28 (9/32) | NR (4.2 to 25.8+) | 78 | 39 (22 to 55) | 3.5 (< 0.1+ to 28.0+) | 69 (50 to 82) | 53 (34 to 70) |
| < 50 | 15 (5/34) | NR (4.2 to 12.6+) | 60 | 36 (20 to 52) | 2.4 (< 0.1+ to 16.0+) | 68 (49 to 81) | 48 (30 to 64) |
| < 25 | 11 (3/28) | NR (5.8 to 9.5+) | 67 | 36 (18 to 54) | 2.4 (< 0.1+ to 16.0+) | 68 (47 to 82) | 48 (29 to 66) |
| < 10 | 12 (3/26) | NR (5.8 to 9.5+) | 67 | 39 (20 to 58) | 3.5 (< 0.1+ to 16.0+) | 65 (44 to 80) | 49 (28 to 66) |
| < 5 | 15 (3/20) | NR (5.8 to 9.5+) | 67 | 45 (22 to 65) | 5.0 (< 0.1+ to 16.0+) | 70 (45 to 85) | 60 (36 to 78) |
| < 1 | 14 (2/14) | NR (5.8 to 9.5+) | 50 | 50 (21 to 74) | 6.6 (< 0.1+ to 12.4) | 79 (47 to 93) | 64 (34 to 83) |
| Unknown | 17 (1/6) | 16.5 (16.5 to 16.5) | 0 | NC | 3.7 (1.2+ to 24.7) | 83 (27 to 97) | NC |
NOTE. NR due to high percentage of ongoing response. Plus symbol (+) indicates a censored value.
Abbreviations: CR, complete response; DOR, duration of response; NC, not calculated; NR, not reached; ORR, objective response rate; OS, overall survival; PD-L1, programmed death–ligand 1; PFS, progression-free survival; PR, partial response.
Data for response and PFS are based on a March 2015 database lock. Data for OS are based on an August 2015 database lock.
Includes patients with initial observations of CR and PR that were subsequently confirmed by repeat scans performed no earlier than 4 weeks after the original observation.
Time from first response to documented progression, death within 100 days of last nivolumab dose, or last tumor assessment before subsequent anticancer therapy (for censored data).
Includes patients with confirmed CR or PR who neither progressed nor died within 100 days of last nivolumab dose.
PFS rate was defined as the probability of a patient remaining progression-free and alive up to 24 weeks.