Duration of treatment and antitumor activity
| . | All patients, N = 31 . | Avelumab treatment group . | Post– auto-HSCT, n = 4 . | Post– allo-HSCT, n = 9* . | ||||
|---|---|---|---|---|---|---|---|---|
| 70 mg Q2W, n = 6 . | 350 mg Q2W, n = 7 . | 500 mg Q2W, n = 6 . | 500 mg Q3W, n = 6 . | 10 mg/kg Q2W, n = 6 . | ||||
| Duration of treatment, median (range), mo | 3.9 (0.5-28.3) | 2.3 (0.5-10.8) | 4.6 (2.1-28.3) | 3.7 (0.9-18.0) | 5.9 (0.7-11.8) | 3.7 (1.8-8.8) | 4.3 (0.9-6.2) | 3.0 (0.5-18.0) |
| BOR, n (%) | ||||||||
| CR | 6 (19.4) | 1 (16.7) | 0 | 0 | 4 (66.7) | 1 (16.7) | 1 (25.0) | 3 (33.3) |
| PR | 7 (22.6) | 1 (16.7) | 0 | 2 (33.3) | 1 (16.7) | 3 (50.0) | 0 | 2 (22.2) |
| SD | 8 (25.8) | 1 (16.7) | 4 (57.1) | 2 (33.3) | 1 (16.7) | 0 | 2 (50.0) | 2 (22.2) |
| PD | 6 (19.4) | 2 (33.3) | 1 (14.3) | 1 (16.7) | 0 | 2 (33.3) | 0 | 1 (11.1) |
| Not evaluable | 4 (12.9) | 1 (16.7)† | 2 (28.6)‡,§ | 1 (16.7)† | 0 | 0 | 1 (25.0)† | 1 (11.1)† |
| ORR (95% CI), % | 41.9 (24.5-60.9) | 33.3 (4.3-77.7) | 0 (0-41.0) | 33.3 (4.3-77.7) | 83.3 (35.9-99.6) | 66.7 (22.3-95.7) | 25.0 (0.6-80.6) | 55.6 (21.2-86.3) |
| Time to response, median (range), mo | 1.5 (1.4-3.5) | 2.6 (1.7-3.5) | — | 1.5 (1.4-1.5) | 1.5 (1.4-1.6) | 1.4 (1.4-2.8) | 1.4 (1.4-1.4) | 1.6 (1.4-3.5) |
| Duration of response, median (95% CI), mo | 6.9 (1.4-NE) | NE (NE-NE) | — | 6.9 (1.4-12.4) | 6.9 (4.3-NE) | 9.4 (1.8-9.4) | NE (NE-NE) | 6.9 (1.8-12.4) |
| . | All patients, N = 31 . | Avelumab treatment group . | Post– auto-HSCT, n = 4 . | Post– allo-HSCT, n = 9* . | ||||
|---|---|---|---|---|---|---|---|---|
| 70 mg Q2W, n = 6 . | 350 mg Q2W, n = 7 . | 500 mg Q2W, n = 6 . | 500 mg Q3W, n = 6 . | 10 mg/kg Q2W, n = 6 . | ||||
| Duration of treatment, median (range), mo | 3.9 (0.5-28.3) | 2.3 (0.5-10.8) | 4.6 (2.1-28.3) | 3.7 (0.9-18.0) | 5.9 (0.7-11.8) | 3.7 (1.8-8.8) | 4.3 (0.9-6.2) | 3.0 (0.5-18.0) |
| BOR, n (%) | ||||||||
| CR | 6 (19.4) | 1 (16.7) | 0 | 0 | 4 (66.7) | 1 (16.7) | 1 (25.0) | 3 (33.3) |
| PR | 7 (22.6) | 1 (16.7) | 0 | 2 (33.3) | 1 (16.7) | 3 (50.0) | 0 | 2 (22.2) |
| SD | 8 (25.8) | 1 (16.7) | 4 (57.1) | 2 (33.3) | 1 (16.7) | 0 | 2 (50.0) | 2 (22.2) |
| PD | 6 (19.4) | 2 (33.3) | 1 (14.3) | 1 (16.7) | 0 | 2 (33.3) | 0 | 1 (11.1) |
| Not evaluable | 4 (12.9) | 1 (16.7)† | 2 (28.6)‡,§ | 1 (16.7)† | 0 | 0 | 1 (25.0)† | 1 (11.1)† |
| ORR (95% CI), % | 41.9 (24.5-60.9) | 33.3 (4.3-77.7) | 0 (0-41.0) | 33.3 (4.3-77.7) | 83.3 (35.9-99.6) | 66.7 (22.3-95.7) | 25.0 (0.6-80.6) | 55.6 (21.2-86.3) |
| Time to response, median (range), mo | 1.5 (1.4-3.5) | 2.6 (1.7-3.5) | — | 1.5 (1.4-1.5) | 1.5 (1.4-1.6) | 1.4 (1.4-2.8) | 1.4 (1.4-1.4) | 1.6 (1.4-3.5) |
| Duration of response, median (95% CI), mo | 6.9 (1.4-NE) | NE (NE-NE) | — | 6.9 (1.4-12.4) | 6.9 (4.3-NE) | 9.4 (1.8-9.4) | NE (NE-NE) | 6.9 (1.8-12.4) |
—, not applicable. NE, not estimable. See Table 1 for expansion of other abbreviations.
Patient count includes the 6 patients who received both auto-HSCT and allo-HSCT.
All postbaseline assessments had an overall response of not evaluable.
No adequate baseline assessment (n = 1).
SD too early (<6 weeks after randomization; n = 1).