Table 1:
Summary of Demographics for Studies DESTINY-Breast01 and DS8201-A-J101 and Pooled Population for the Target Indication (ITT population)(12)
| Pooled | Study | ||
|---|---|---|---|
| HER2-positive Breast Cancer 5.4mg/kg (N = 235) * | DESTINY-Breast01 HER2-positive Breast Cancer 5.4mg/kg (N = 184) | DS8201-A-J101 HER2-positive Breast Cancer 5.4mg/kg (N = 51) * | |
| Sex, n (%) | |||
| Male | 1 (0.4) | 0 | 1 (2) |
| Female | 234 (99.6) | 184 (100) | 50 (98) |
| Age (years) | |||
| Median | 56 | 55 | 58 |
| Range | 28–96 | 28–96 | 28–77 |
| Age Group | |||
| <65 years | 174 (74) | 140 (76) | 34 (67) |
| ≥65 years | 61 (26) | 44 (24) | 17 (33) |
| <75 years | 224 (95) | 175 (95) | 49 (96) |
| ≥75 years | 11 (5) | 9 (5) | 2 (4) |
| Race, n (%) | |||
| White | 120 (51) | 101 (55) | 19 (36) |
| Black or African American | 7 (3) | 4(2) | 3 (6) |
| Asian | 97 (42) | 72 (38) | 27 (54) |
| American Indian or Alaska Native | 2 (0.9) | 1 (0.5) | 1 (2) |
| Native Hawaiian or Pacific Islander | 1 (0.4) | 1 (0.5) | 0 |
| Other | 4 (1.7) | 3 (1.6) | 1 (2) |
| Missing | 4 (1.7) | 4 (2.2) | 0 |
| Region/Country of Enrollment, n (%) | |||
| North America | 83 (35) | 53 (29) | 30 (59) |
| United States | 83 (35) | 53 (29) | 30 (59) |
| Asia | 84 (36) | 63 (34) | 21 (41) |
| Japan | 51 (22) | 30 (16) | 21 (41) |
| Korea | 33 (14) | 33 (18) | 0 |
| Europe | 68 (29) | 68 (37) | 0 |
| Belgium | 7 (3.0) | 7 (3.8) | 0 |
| France | 19 (8) | 19 (10) | 0 |
| Italy | 9 (3.8) | 9 (4.9) | 0 |
| Spain | 21 (9) | 21 (11) | 0 |
| United Kingdom | 12 (5) | 12 (7) | 0 |
| ECOG | |||
| 0 | 135 (57) | 102 (55) | 33 (65) |
| 1 | 98 (42) | 81 (44) | 17 (33) |
| 2 | 1 (0.4) | 1 (0.5) | 0 |
| Missing | 1 (0.4) | 0 | 1 (2) |
*
One patient (10117015) was not dosed in DS8201-A-J101