Table 2.
Tumor Response (Progression-free Survival Population).*
Variable | Experimental (N = 276) | Control (N = 274) |
---|---|---|
Objective response (95% CI) — % | 43 (37–49) | 36 (30–42) |
Best overall response — no. (%) | ||
Complete response | 7 (3) | 9 (3) |
Partial response | 112 (41) | 89 (32) |
Stable disease | 119 (43) | 100 (36) |
Progressive disease | 23 (8) | 55 (20) |
Could not be evaluated or data were missing | 15 (5) | 21 (8) |
Disease control — no. (%)† | 238 (86) | 198 (72) |
Median time to response (range) — mo | 2.4 (1.5–17.1) | 2.3 (1.9–16.8) |
Median duration of response (95% CI) — mo | NR (20.2-NR) | NR (NE-NE) |
Patients were assigned to receive cabozantinib in addition to nivolumab and ipilimumab (experimental group) or placebo in addition to nivolumab and ipilimumab (control group). Responses were assessed by an independent radiology committee according to the Response Evaluation Criteria in Solid Tumors, version 1.1; members of the committee were unaware of trial-group assignments. Complete and partial responses were confirmed. The data-cutoff date was January 31, 2022. Percentages may not total 100 because of rounding. NE denotes could not be estimated, and NR not reached.
Disease control was defined as a complete response, partial response, or stable disease as the best overall response.