Table 2.
Daily Dose (mg) | N | ORR N (%) (95% CI) |
---|---|---|
180 | 3 | 1 (33) (0.8, 91) |
360 | 16 | 4 (25) (7, 52) |
720 | 6 | 3 (50) (12, 88) |
960 | 34 | 16 (47) (30, 65) |
CI, confidence interval; ORR, overall response rate.
Source: U.S. Food and Drug Administration. NDA Multi-disciplinary Review and Evaluation (NDA 214665) and Approval Package: LUMAKRAS (sotorasib) (ref 19).