Table 1: Baseline Demographics and Disease Characteristics in the Efficacy and Safety Populations of Study LIBRETTO-001.
Efficacy Population N = 41 | Safety Population N = 796 | |
---|---|---|
Sex, n (%) | ||
Female | 22 (54) | 390 (49) |
Male | 19 (46) | 406 (51) |
Age at diagnosis (years), median [range] | 50 [21, 85] | 59 [15, 92] |
Race, n (%) | ||
Asian | 10 (24) | 185 (23) |
Black or African American | 2 (5) | 25 (3) |
White | 28 (68) | 545 (69) |
Ethnicity, n (%) | ||
Hispanic or Latino | 3 (7) | 40 (5) |
Not Hispanic or Latino | 37 (90) | 737 (93) |
Region, n (%) | ||
Asia | 12 (29) | 185 (23) |
Europe | 3 (7) | 123 (15) |
North America | 26 (63) | 473 (59) |
ECOG performance status at study entry, n (%) | ||
0 | 14 (34) | 294 (37) |
1 | 25 (61) | 464 (58) |
History of Metastatic Disease | ||
Yes | 95% | 98% |
Number of Prior Lines of Therapy, median [range] | 2 [0, 9] | 1 [0, 15] |
ECOG = Eastern Cooperative Oncology Group
Source: U.S. Food and Drug Administration. sNDA Multi-disciplinary Review and Evaluation and Approval Package: RETEVMO (selpercatinib).19