Table 1 –
ClarIDHy Trial : Baseline demographics and disease characteristics
| Ivosidenib (n= 124) | Placebo (n= 61) | |
|---|---|---|
| Median age, years (range) | 61 (33–80) | 63 (40–83) |
| Sex | ||
| Female, n (%) | 80 (65%) | 37 (61%) |
| Male, n (%) | 44 (35%) | 24 (39%) |
| Race | ||
| White | 71 (56%) | 35 (57%) |
| Asian | 15 (12%) | 8 (13%) |
| Black | 1 (1%) | 1 (2%) |
| Other | 3 (2%) | 0 |
| Missing/not reported | 36 (29%) | 17 (28%) |
| Ethnicity | ||
| Hispanic or Latino | 7 (6%) | 2 (3%) |
| Not Hispanic or Latino | 84 (67%) | 40 (66%) |
| Missing/not reported | 35 (28%) | 19 (31%) |
| ECOG | ||
| PS 0, n (%) | 49 (40%) | 19 (31%) |
| PS 1, n (%) | 74 (60%) | 41 (67%) |
| Prior lines of therapy | ||
| One prior line, n (%) | 66 (53%) | 33 (54%) |
| Two prior lines, n (%) | 58 (47%) | 28 (46%) |
| Primary tumor location | ||
| Intrahepatic, n (%) | 111 (90%) | 58 (95%) |
| Extrahepatic, n (%) | 1 (<1%) | 1 (2%) |
| Perihilar, n (%) | 4 (3%) | 0 |
| Unknown, n (%) | 8 (5%) | 2 (3%) |
| Extent of disease | ||
| Metastatic1, n (%) | 115 (93%) | 56 (92%) |
| Locoregional, n (%) | 9 (7%) | 5 (8%) |
| IDH1 mutation | ||
| R132C, n (%) | 84 (68%) | 45 (74%) |
| R132G, n (%) | 17 (14%) | 6 (10%) |
| R132H, n (%) | 0 | 2 (3%) |
| R132L, n (%) | 21 (17%) | 7 (11%) |
| R132S, n (%) | 2 (2%) | 1 (2%) |
ECOG PS: Eastern Cooperative Group Performance Status; IDH: isocitrate dehydrogenase
1
Patients with both locoregional and metastatic disease are considered metastatic
Source: FDA analysis, unpublished data