Table 2:
Baseline Disease Characteristics for SOPHIA (ITT population)
| Margetuximab plus Chemotherapy (N = 266) | Trastuzumab plus Chemotherapy (N = 270) | Total (N = 536) | |
|---|---|---|---|
| Hormone Receptor Status, n (%) | |||
| Positive (ER+ &/or PgR+) | 164 (61.7) | 170 (63.0) | 334 (62.3) |
| Negative (ER- and PgR-) | 102 (38.3) | 98 (36.3) | 200 (37.3) |
| Unknown | 0 | 2 (0.7) | 2 (0.4) |
| HER2 Result * , n (%) | |||
| ISH amplified | 117 (44.0) | 128 (47.4) | 245 (45.7) |
| IHC3+ | 149 (56.0) | 142 (52.6) | 291 (54.3) |
| Prior Pertuzumab, n (%) | |||
| Yes | 266 (100) | 269 (99.6) | 535 (99.8) |
| No | 0 (0) | 1 (0.4) | 1 (0.2) |
| Disease Status at Study Entry, n (%) | |||
| Locally Advanced, Unresectable | 6 (2.3) | 6 (2.2) | 12 (2.2) |
| Metastatic | 260 (97.7) | 264 (97.8) | 524 (97.8) |
| Number of Metastatic Sites, n (%) | |||
| ≤ 2 | 138 (51.9) | 144 (53.3) | 282 (52.6) |
| > 2 | 128 (48.1) | 126 (46.7) | 254 (47.4) |
| Site(s) of Metastases at Study Entry, n (%) | |||
| Bone | 153 (57.5) | 155 (57.4) | 308 (57.5) |
| Lymph Node | 140 (52.6) | 151 (55.9) | 291 (54.3) |
| Lung | 124 (46.6) | 126 (46.7) | 250 (46.6) |
| Liver | 93 (35.0) | 95 (35.2) | 188 (35.1) |
| Breast | 44 (16.5) | 37 (13.7) | 81 (15.1) |
| Skin | 41 (15.4) | 32 (11.9) | 73 (13.6) |
| Brain | 37 (13.9) | 34 (12.6) | 71 (13.2) |
| Pleura | 22 (8.3) | 17 (6.3) | 39 (7.3) |
| Other Visceral | 21 (7.9) | 15 (5.6) | 36 (6.7) |
| Other non-Visceral | 15 (5.6) | 16 (5.9) | 31 (5.8) |
| Peritoneum | 9 (3.4) | 9 (3.3) | 18 (3.4) |
| Adrenal Medulla | 4 (1.5) | 2 (0.7) | 6 (1.1) |
| Ovary | 4 (1.5) | 0 | 4 (0.7) |
*
Four patients in each group did not have reference laboratory assessments but were confirmed HER2+ on central laboratory testing.
Source: Margetuximab Assessment Aid submitted to FDA (Study 04 CSR - Table 12 and 14.1.16)24