Table 1.
Patient Baseline and Disease Characteristics
| Characteristic | N = 35 |
|---|---|
| Median age, years (range) | 57 (28–75) |
| Sex, n (%) | |
| Male | 24 (68.6) |
| Female | 11 (31.4) |
| ECOG performance status, n (%)a | |
| 0 | 12 (34.3) |
| 1 | 22 (62.9) |
| 2 | 1 (2.9) |
| Prior anticancer regimens, n (%) | |
| 1 | 32 (91.4) |
| 2 | 2 (5.7) |
| 3 | 1 (2.9) |
| Prior systemic steroid use, n (%)b | 18 (51.4) |
| Median time since initial GBM diagnosis, months (range) | 14.5 (4.5–50.2) |
| IDH mutation status, n (%) | |
| Positive | 6 (17.1) |
| Negative | 29 (82.9) |
| PD-L1 tumor expression, n (%) | |
| Positive (≥1% tumor cells) | 24 (68.6) |
| Negative (<1% tumor cells)c | 11 (31.4) |
| Subsequent anticancer treatment, n (%)d | |
| Any | 11 (31.4) |
| Cytotoxic therapy | 8 (22.9) |
| Bevacizumab | 7 (20.0) |
| Tumor volume at baseline, n (%) | |
| <15 cm3 | 12 (34.3) |
| ≥15 cm3 | 20 (57.1) |
| N/A | 3 (8.6) |
| Maximum dexamethasone-equivalent dose, n (%)b | |
| None | 17 (48.6) |
| ≤2 mg | 6 (17.1) |
| >2–4 mg | 4 (11.4) |
| >4 mg | 8 (22.9) |
| Any surgery prior to initiation of study therapy, n (%) | |
| Gross total resection | 15 (42.9) |
| Subtotal resection | 15 (42.9) |
| Biopsy | 2 (5.7) |
| Unknown | 1 (2.9) |
| None | 2 (5.7) |
ECOG, Eastern Cooperative Oncology Group; GBM, glioblastoma; IDH, isocitrate dehydrogenase.
aRecorded on week 1, day 1, and was not used as an inclusion criterion. bReceived between screening and initial dose of bintrafusp alfa. cFour of 6 patients with IDH-mutant tumors had PD-L1-negative tumors. dFive patients received >1 therapy.