Table 2.
Antitumor activity among patients with sRCC by BICR
| Avelumab + axitinib (N = 47) | Sunitinib (N = 61) | |
|---|---|---|
| Confirmed ORR, % (95% CI) | 46.8 (32.1-61.9) | 21.3 (11.9-33.7) |
| Odds ratio (95% CI) | 3.249 (1.300-8.236) | — |
| Best overall response, n (%) | ||
| Complete response | 2 (4.3) | 0 |
| Partial response | 20 (42.6) | 13 (21.3) |
| Stable disease | 13 (27.7) | 18 (29.5) |
| Noncomplete response/nonprogressive disease | 0 | 1 (1.6) |
| Progressive disease | 7 (14.9) | 22 (36.1) |
| Not evaluable | 5 (10.6)a | 7 (11.5)b |
| Median time to response (range), months | 1.6 (1.2-9.8) | 3.1 (1.2-11.1) |
| Difference in mean duration of response versus sunitinib (95% CI), months | 2.4 (0.9-3.9) | — |
BICR, blinded independent central review; CI, confidence interval; ORR, objective response rate; sRCC, sarcomatoid renal cell carcinoma.
a
No post-baseline assessments due to early death (n = 1) or other reasons (n = 4).
b
No post-baseline assessments due to early death (n = 2), other reasons (n = 1), patient started new anticancer therapy before first post-baseline assessment (n = 1), or patient had stable disease <6 weeks after randomization (n = 3).