Table 3.
Adverse Events Reported in Greater Than or Equal to 20% of Selpercatinib-Treated Patients With RET Fusion-Positive NSCLC in the Overall Safety Population and in Subgroups With or Without Prior ICI Therapy
| AEs | Prior ICI Therapy (n = 152) | No Prior ICI Therapy (n = 177) | Overall (N = 329) | |||
|---|---|---|---|---|---|---|
| n (%) | Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 |
| Any TEAE | 150 (98.7) | 96 (63.2) | 175 (98.9) | 100 (56.5) | 325 (98.8) | 196 (59.6) |
| Dry mouth | 57 (37.5) | 0 | 77 (43.5) | 0 | 134 (40.7) | 0 |
| Diarrhea | 56 (36.8) | 5 (3.3) | 77 (43.5) | 4 (2.3) | 133 (40.4) | 9 (2.7) |
| Increased ALT | 50 (32.9) | 21 (13.8) | 52 (29.4) | 16 (9.0) | 102 (31.0) | 37 (11.2) |
| Increased AST | 50 (32.9) | 19 (12.5) | 58 (32.8) | 9 (5.1) | 108 (32.8) | 28 (8.5) |
| Hypertension | 47 (30.9) | 23 (15.1) | 58 (32.8) | 32 (18.1) | 105 (31.9) | 55 (16.7) |
| Peripheral edema | 40 (26.3) | 0 | 41 (23.2) | 0 | 81 (24.6) | 0 |
| Fatigue | 37 (24.3) | 3 (2.0) | 41 (23.2) | 1 (0.6) | 78 (23.7) | 4 (1.2) |
| Pyrexia | 37 (24.3) | 1 (0.7) | 28 (15.8) | 0 | 65 (19.8) | 1 (0.3) |
| Thrombocytopenia | 36 (23.7) | 9 (5.9) | 21 (11.9) | 7 (4.0) | 57 (17.3) | 16 (4.9) |
| Nausea | 32 (21.1) | 1 (0.7) | 37 (20.9) | 1 (0.6) | 69 (21.0) | 2 (0.6) |
| Rash | 32 (21.1) | 0 | 39 (22.0) | 2 (1.1) | 71 (21.6) | 2 (0.6) |
| Headache | 31 (20.4) | 1 (0.7) | 34 (19.2) | 2 (1.1) | 65 (19.8) | 3 (0.9) |
| Constipation | 26 (17.1) | 0 | 40 (22.6) | 3 (1.7) | 66 (20.1) | 3 (0.9) |
Note: Data cutoff date of December 16, 2019.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ICI, immune checkpoint inhibitor; TEAE, treatment-emergent adverse event.