Table 1.
Efficacy of sotorasib during the CodeBreaK 100 trial
| Endpoint | Results (95% CI) |
|---|---|
| Primary analysis in 123 patients enrolled in the phase II portion (data cutoff date 1 Sep 2020) [17] | |
| Objective response rate, % | 37.4 (28.8–46.6)a,b |
| Disease control rate, % | 80.5 (72.4–87.1) |
| Median duration of response, mo | 8.4 (6.9–8.4) |
| Median progression-free survival, mo | 6.7 (4.9–8.1) |
| Median overall survival, mo | 12.0 (9.5–NE) |
| Updated analysis in 124 patients enrolled in the phase II portion (data cutoff date 15 Mar 2021) [16] | |
| Objective response rate, % | 37.1 (28.6–46.2)b |
| Disease control rate, % | 80.6 (72.6–87.2) |
| Median duration of response, mo | 11.1 (6.9–NE)c |
| Median progression-free survival, mo | 6.8 (5.1–8.2) |
| Median overall survival, mo | 12.5 (10.0–NE)d |
| Updated analysis in 174 patients enrolled in the phase I and II portions (data cutoff date not reported) [19] | |
| Objective response rate, % | 40.7 (33.2–48.4) |
| Disease control rate, % | Not reported |
| Median duration of response, mo | 12.3 (7.1–14.6) |
| Median progression-free survival, mo | 6.3 (5.3–8.2) |
| Median overall survival, mo | 12.5 (10.0–17.8) |
Objective response was defined as a complete or partial response and confirmation after ≥ 4 wks. Disease control was defined as a complete or partial response and confirmation, or stable disease for ≥ 5 wks [16, 17]
NE not evaluable
aA patient was found to be eligible for the primary analysis during an updated analysis. In 124 patients, the objective response rate was 36.3% (95% CI 27.9–45.4%)
bPrimary endpoint
cThe median duration of response was 11.1 mo (95% CI 6.9–15.0 mo) in an updated analysis (data cutoff date 20 Jun 2021)
dAssessed in all enrolled 126 patients