Efficacy of avelumab after ≥6 months and ≥1 year of follow-up
| Efficacy parameter | ≥6 months of follow-up [8] | ≥1 year of follow-up |
|---|---|---|
| (N = 88) | (N = 88) | |
| ORR (95% CI), % | 31.8 (21.9-43.1)a | 33.0 (23.3-43.8) |
| Confirmed BOR, n (%) | ||
| CR | 8 (9.1) | 10 (11.4) |
| PR | 20 (22.7) | 19 (21.6) |
| SD | 9 (10.2) | 9 (10.2) |
| PD | 32 (36.4) | 32 (36.4) |
| Non-CR/non-PD | 1 (1.1)b | 0 |
| Not evaluablec | 18 (20.5) | 18 (20.5) |
| Response durability | (n = 28) | (n = 29) |
| Median DOR (95% CI), months | NE (8.3-NE) | NE (18.0-NE) |
| Range | 2.8-17.5+ | 2.8-23.3+ |
| 6-month DRR (95% CI), %d | 29.1 (19.5-38.8) | 30.6 (20.9-40.3) |
| Proportion of responses with duration ≥6 months (95% CI), %e | 92 (70-98) | 93 (74-98) |
| Proportion of responses with duration ≥1 year (95% CI), %e | NA | 74 (53-87) |
| Proportion of patients in response at 1 year (95% CI), %f | NA | 23.9 (15.4-34.1) |
BOR Best overall response, CR Complete response, DOR Duration of response, DRR Durable response rate, NA Not applicable, NE Not estimable, ORR Objective response rate, PD Progressive disease, PR Partial response, SD Stable disease
a 95.9% CI adjusted for multiple testing
b One patient did not have measurable disease at baseline; thus, a BOR of PR or SD could not be distinguished
c Patients not evaluable for a confirmed BOR had no baseline lesions identified by independent review committee (n = 4), baseline but no postbaseline assessments (n = 10), all nonassessable postbaseline assessments (n = 2), no postbaseline tumor assessment before the start of new anticancer therapy (n = 1), or SD of insufficient duration (n = 1)
d ORR multiplied by Kaplan-Meier estimate for proportion of responses with a duration of ≥6 months
e Based on Kaplan-Meier estimates
f 95% exact CI using the Clopper-Pearson method