Table 1. Spectrum of Fatal Immune-Related Adverse Events in Vigilyze.
Variable | No. (%) | P Value | ||
---|---|---|---|---|
Ipilimumab (n = 193) | Anti–PD-1/PD-L1 (n = 333) | Combination (n = 87) | ||
Types of cancera | <.001 | |||
Melanoma | 136 (96) | 50 (18) | 49 (66) | |
Lung cancer | 0 | 152 (54) | 17 (23) | |
Other | 5 (4) | 78 (28) | 8 (11) | |
Type of fatal irAE | ||||
Colitis | 135 (70) | 58 (17) | 32 (37) | <.001 |
Pneumonitis | 15 (8) | 115 (35) | 12 (14) | <.001 |
Hepatitis | 31 (16) | 74 (22) | 19 (22) | .23 |
Hypophysitis | 10 (5) | 3 (1) | 2 (2) | .01 |
Cardiac | 3 (2) | 27 (8) | 22 (25) | <.001 |
Myositis | 1 (0.5) | 22 (7) | 11 (13) | <.001 |
Nephritis | 1 (0.5) | 7 (2) | 3 (4) | .19 |
Adrenal | 8 (4) | 6 (2) | 3 (4) | .26 |
Neurologic | 11 (6) | 50 (15) | 7 (8) | .003 |
Hematologic | 3 (2) | 14 (4) | 2 (2) | .22 |
Other (skin, thyroid, diabetes, other gastrointestinal) | 13 (7) | 24 (8) | 7 (8) | .93 |
Other clinical features | ||||
Median time to irAE, days | 40 | 40 | 14 | .01 |
>1 concurrent irAE, % | 27 (14) | 51 (15) | 24 (28) | .01 |
Reporting year | ||||
2014 or before | 98 (51) | 3 (1) | 2 (2) | <.001 |
2015 | 45 (23) | 20 (6) | 9 (10) | <.001 |
2016 | 21 (11) | 88 (28) | 17 (20) | .001 |
2017 | 26 (13) | 192 (58) | 44 (51) | <.001 |
2018 (up to January 15) | 3 (2) | 30 (9) | 15 (17) | <.001 |
Abbreviations: irAE, immune-related adverse event; PD-L1, programmed death ligand-1; PD-1, programmed death-1.
Percent of known (52 patients treated with ipilimumab, 53 with anti–PD-1/PD-L1, and 13 with combination did not list cancer types).