Table 3.
Antitumor activity.
| ITT population | Glembatumumab vedotin (n = 218) | Capecitabine (n = 109) | ||
|---|---|---|---|---|
| PFS by IRC | ||||
| Median, months (95% CI) | 2.9 | (2.8, 3.5) | 2.8 | (1.6, 3.2) |
| OS | ||||
| Median, months (95% CI) | 8.9 | (7.9, 10.5) | 8.7 | (6.9, 10.8) |
| Duration of OS follow-up | ||||
| Median, months (95% CI) | 12.4 | (10.9, 15.0) | 13.6 | (10.1, 20.0) |
| Measurable disease population | Glembatumumab vedotin (n = 179) | Capecitabine (n = 100) | ||
| ORR by IRC, n (% [95% CI]) | 29 (16%) | 11.1, 22.4 | 15 (15%) | 8.6, 23.5 |
| Confirmed CR, n (%) | 1 (<1%) | 3 (3%) | ||
| Confirmed PR, n (%) | 28 (16%) | 12 (12%) | ||
| Any response*, n (% [95% CI]) | 46 (26%) | 19.5, 32.8 | 21 (21%) | 13.5, 30.3 |
| SD, n (%) | 83 (46%) | 27 (27%) | ||
Data are n (%).
ITT intention-to-treat population, includes all enrolled patients, PFS progression-free survival, IRC Independent Review Committee, OS overall survival, ORR objective response rate per RECIST 1.1, CR complete response, PR partial response, SD stable disease (minimum interval ≥6 weeks from baseline), DOR duration of response.
*Any response including those not confirmed at subsequent disease assessment.