Table 2.
Efficacy of Sotorasib Therapy.*
Variable | Phase 1 (N = 12) | Phase 2 (N = 26) | Combined Phase 1–2 (N = 38) |
---|---|---|---|
Best overall response — no. (%)† | |||
Confirmed complete response | 0 | 0 | 0 |
Confirmed partial response | 3 (25) | 5 (19) | 8 (21) |
Stable disease | 6 (50) | 18 (69) | 24 (63) |
Progressive disease | 2 (17) | 3 (12) | 5 (13) |
Could not be evaluated | 0 | 0 | 0 |
Not assessed | 1 (8) | 0 | 1 (3) |
Percentage of patients with objective response (95% CI) — % | 25 (6–57) | 19 (7–39) | 21 (10–37) |
Percentage of patients with disease control (95% CI) — %‡ | 75 (43–95) | 89 (70–98) | 84 (69–94) |
Median time to objective response (range) — mo§ | 1.4 (1.3–1.5) | 2.8 (1.3–5.6) | 1.5 (1.3–5.6) |
Median duration of response (95% CI) — mo§¶ | — | — | 5.7 (1.6–NE) |
An objective response was defined as a complete or partial response. NE denotes could not be evaluated.
The best overall response was determined by blinded independent central review.
Disease control was defined as an objective response or stable disease.
The median time to objective response and the median duration of response were calculated for the patients who had a confirmed objective response.
The median duration of response (Kaplan–Meier estimates) is not provided for individual phases because of the small number of patients.