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. Author manuscript; available in PMC: 2022 Oct 14.
Published in final edited form as: Clin Cancer Res. 2022 Apr 14;28(8):1482–1486. doi: 10.1158/1078-0432.CCR-21-3074

Table 3.

Summary of Overall Response and Duration of Responses per Blinded Independent Central Review in CodeBreaK 100

Efficacy parameter Primary Efficacy Population
N = 124
Post-chemotherapy and Immunotherapy Population
N = 100

Dose expansion portion (N = 124)
Overall response rate, n (%) 45 (36) 31 (31)
Clopper-Pearson 95% CI (28, 45) (22, 41)
 Complete Response 3 (2.5) 1 (1.0)
Duration of Response (DOR)
 Median, months (95% CI) 10.0 (6.9, NE) 10 (6.9, NE)
 Range, months (1.3+, 11.1) (1.3+, 11.1)
 N (%) w/DOR ≥ 6 months 26 (58) 18 (58)

CI: confidence interval; NE: not estimable

Source: LUMAKRAS (sotorasib) package insert (ref 16)