Table 1.
Patient demographics and baseline disease characteristics (modified intent-to-treat population)
| Characteristic | AS/OBI-821 (N=224) |
Placebo (N=124) |
| Median age, years (range) | 53 (30–87) | 52 (30–82) |
| Ethnicity, n (%) | ||
| Asian | 185 (82.6) | 97 (78.2) |
| Caucasian | 39 (17.4) | 27 (21.8) |
| Country, n (%) | ||
| Taiwan | 121 (54.0) | 63 (50.8) |
| USA | 44 (19.6) | 27 (21.8) |
| South Korea | 42 (18.8) | 24 (19.4) |
| Hong Kong | 13 (5.8) | 7 (5.6) |
| India | 4 (1.8) | 3 (2.4) |
| ECOG performance status, n (%) | ||
| 0 | 165 (74.0)* | 92 (74.2) |
| 1 | 58 (26.0) | 32 (25.8) |
| Median time from first metastatic diagnosis to day 1, months (range) | 12 (1–87) | 13.5 (3–151) |
| Metastatic disease, n (%) | ||
| De novo | 72 (32.1) | 37 (29.8) |
| Relapsed | 152 (67.9) | 87 (70.2) |
| Disease-free interval | (n=152) | (n=87) |
| Median, months (range) | 52 (0.5–298) | 50 (0.5–239) |
| >24 months, n (%) | 119 (78.3) | 61 (70.1) |
| 12–24 months, n (%) | 17 (11.2) | 15 (17.2) |
| <12 months, n (%) | 16 (10.5) | 11 (12.6) |
| Number of progression events after diagnosis of metastatic disease, n (%) | ||
| 0 | 137 (61.2) | 77 (62.1) |
| 1 | 67 (29.9) | 37 (29.8) |
| 2 | 20 (8.9) | 10 (8.1) |
| Disease status, n (%) | ||
| Measurable | 104 (46.4) | 49 (39.5) |
| Evaluable | 91 (40.6) | 57 (46.0) |
| No evident disease | 29 (12.9) | 18 (14.5) |
| Number of sites of disease, n (%) | ||
| 0 | 33 (14.7) | 19 (15.3) |
| 1 | 81 (36.2) | 38 (30.6) |
| 2 | 67 (29.9) | 42 (33.9) |
| ≥3 | 43 (19.2) | 25 (20.2) |
| Sites of disease, n (%) | ||
| Bone | 91 (40.6) | 71 (57.3) |
| Visceral | 108 (48.2) | 60 (48.4) |
| Nodes | 70 (31.3) | 34 (27.4) |
| Breast | 33 (14.7) | 10 (8.1) |
| Soft tissue/skin | 20 (8.9) | 6 (4.8) |
| Biologic subtypes, n (%) | ||
| HR+, HER2– | 161 (71.9) | 84 (67.8) |
| Triple negative | 28 (12.5) | 17 (13.7) |
| HER2+ | 35 (15.6) | 23 (18.5) |
| Prior treatments for metastatic disease (n/N,† %) | ||
| Chemotherapy | 199/224 (88.8) | 110/124 (88.7) |
| Hormone therapy | 134/161 (83.2) | 73/84 (86.9) |
| HER2− targeted therapy | 26/35 (74.3) | 17/23 (73.9) |
| mTOR inhibitor | 0/161 (0.0) | 1/84 (1.2) |
| Stratification factors, n (%) | ||
| HT with PR/SD | 129 (57.6) | 68 (54.8) |
| HT with CR | 11 (4.9) | 8 (6.5) |
| No HT with PR/SD | 73 (32.6) | 42 (33.9) |
| No HT with CR | 11 (4.9) | 6 (4.8) |
| Globo H expression by IHC, n (%) | (n=159) | (n=84) |
| 0 | 44 (27.7) | 25 (29.8) |
| 1+ | 57 (35.8) | 30 (35.7) |
| 2+ | 27 (17.0) | 10 (11.9) |
| 3+ | 31 (19.5) | 19 (22.6) |
*One patient had a missing assessment.
†N=patients for whom treatment would be appropriate (HT, mTOR inhibitor for patients with HR+ tumors; HER2− targeted therapy for patients with HER2+ tumors).
CR, complete response; ECOG, Eastern Cooperative Oncology Group; HER2, human epidermal growth factor receptor 2; HER2−, HER2-negative; HER2+, HER2-positive; HR+, hormone receptor-positive; HT, hormone therapy; IHC, immunohistochemistry; mTOR, mammalian target of rapamycin; PR, partial response; SD, stable disease.