Table 2.
Baseline demographics and disease characteristics of patients across all cohorts (safety population)
| Monotherapy all (dose escalation + cohort expansion) n = 269 | Monotherapy dose escalation 1–1,200 mg Q2W (n = 53) | Monotherapy cohort expansion tebotelimab 600 mg Q2W (n = 216) | Combination all (dose escalation + cohort expansion) tebotelimab 300 mg or 600 mg Q3W + margetuximab 15 mg kg−1 Q3W (n = 84)a | |
|---|---|---|---|---|
| Median age (range), years | 61 (24–84) | 64 (24–84) | 60 (27–84) | 61 (23–86) |
| Sex, n (%) | ||||
| Male | 114 (42.4) | 32 (60.4) | 82 (38.0) | 27 (32.1) |
| Female | 155 (57.6) | 21 (39.6) | 134 (62.0) | 57 (67.9) |
| ECOG PS, n (%) | ||||
| 0 | 76 (28.3) | 21 (39.6) | 55 (25.5) | 33 (39.3) |
| 1 | 193 (71.7) | 32 (60.4) | 161 (74.5) | 51 (60.7) |
| Median prior lines of therapy (range) | 2 (1–9) | 2 (1–9) | 2 (1–9)b | 2 (1–9) |
| Prior CPI therapy, n (%) | ||||
| Yes | 85 (31.6) | 24 (45.3) | 61 (28.2) | 14 (16.7) |
| No | 184 (68.4) | 29 (54.7) | 155 (71.8) | 70 (83.3) |
| Prior HER2-directed therapy, n (%) | ||||
| Yes | NA | NA | NA | 58 (69.0) |
| No | NA | NA | NA | 26 (31.0) |
| Tumor types, n (%) | ||||
| EOC | 43 (16.0) | 3 (5.7) | 40 (18.5) | 7 (8.3) |
| NSCLC | 40 (14.9) | 5 (9.4) | 35 (16.2) | 1 (1.2) |
| TNBC | 40 (14.9) | 1 (1.9) | 39 (18.1) | 2 (2.4) |
| SCCHN | 33 (12.3) | 2 (3.8) | 31 (14.4) | 1 (1.2) |
| DLBCL | 20 (7.4) | 0 | 20 (9.3) | 0 |
| Cholangiocarcinoma | 18 (6.7) | 1 (1.9) | 17 (7.9) | 6 (7.1) |
| Cervical cancer | 17 (6.3) | 0 | 17 (7.9) | 1 (1.2) |
| SCLC | 16 (5.9) | 0 | 16 (7.4) | 0 |
| HCC | 13 (4.8) | 13 (24.5) | 0 | 0 |
| CRC | 6 (2.2) | 6 (11.3) | 0 | 9 (10.7) |
| Mesothelioma | 5 (1.9) | 5 (9.4) | 0 | 0 |
| Soft tissue sarcoma | 4 (1.5) | 4 (7.5) | 0 | 0 |
| Breast cancer (not TNBC) | 2 (0.7) | 1 (1.9) | 1 (0.5) | 34 (40.5) |
| GEJ | 1 (0.4) | 1 (1.9) | 0 | 6 (7.1) |
| Bladder cancer | 1 (0.4) | 1 (1.9) | 0 | 3 (3.6) |
| GC | 1 (0.4) | 1 (1.9) | 0 | 1 (1.2) |
| Adenoid cystic carcinoma | 1 (0.4) | 1 (1.9) | 0 | 1 (1.2) |
| Ewing sarcoma | 1 (0.4) | 1 (1.9) | 0 | 0 |
| Jejunal cancer | 1 (0.4) | 1 (1.9) | 0 | 0 |
| Mucoepidermoid carcinoma | 1 (0.4) | 1 (1.9) | 0 | 0 |
| Neuroendocrine tumor | 1 (0.4) | 1 (1.9) | 0 | 0 |
| Pancreatic cancer | 1 (0.4) | 1 (1.9) | 0 | 0 |
| Phyllodes tumor | 1 (0.4) | 1 (1.9) | 0 | 0 |
| Renal cell carcinoma | 1 (0.4) | 1 (1.9) | 0 | 0 |
| Squamous cell carcinoma | 1 (0.4) | 1 (1.9) | 0 | 0 |
| Esophageal cancer | 0 | 0 | 0 | 7 (8.3) |
| Uterine cancer | 0 | 0 | 0 | 4 (4.8) |
Data cutoff: 1 December 2021.
aEvidence of HER2 expression (not confirmed centrally) was required for eligibility; such evidence was obtained from local testing results, performed at any time before enrollment. The dates of the local HER2 test (and the corresponding biopsy age) ranged from 3 d to 8 y before the date of enrollment. Six patients had documented HER2 expression from a local test done within 1 year before the time of enrollment.
bMonotherapy cohort expansion median prior lines of therapy derived from n = 214 patients (two patients without this information available). NA, not applicable.