Table. Outcomes by RECIST Version 1.1, per Independent Review Committee Assessment.
| Outcome | Patient Follow-up Group | |
|---|---|---|
| ≥3 mo | ≥6 mo | |
| Responsea | ||
| Confirmed ORR, % (95% CI) | 62.1 (42.3-79.3) | 71.4 (41.9-91.6) |
| Confirmed BOR, No. (%) | ||
| Complete response | 4 (13.8) | 4 (28.6) |
| Partial response | 14 (48.3) | 6 (42.9) |
| Stable disease | 3 (10.3) | 1 (7.1) |
| Progressive disease | 7 (24.1) | 2 (14.3) |
| Nonevaluableb | 1 (3.4) | 1 (7.1) |
| Response durabilityc | ||
| Median DOR (95% CI), mo | NE (4.0 to NE) | NE (4.0 to NE) |
| Proportion of responses with duration ≥3 mo, % (95% CI) | 93 (61-99) | 100 (NE) |
| Proportion of responses with duration ≥6 mo, % (95% CI) | 83 (46-96) | 89 (43-98) |
Abbreviations: BOR, best overall response; DOR, duration of response; NE, not estimable; ORR, objective response rate; RECIST, Response Evaluation Criteria in Solid Tumors.
a
Includes 29 patients with at least 3 and 14 with at least 6 months of follow-up.
b
Patient died before tumor assessment due to an adverse event unrelated to treatment with avelumab.
c
Includes 18 patients with at least 3 and 10 with at least 6 months of follow-up.