Table 1.
Baseline characteristics (Phase 2 study; mITT populationa).
| Tepotinib | Sorafenib | Total | |
|---|---|---|---|
| n = 38 | n = 37 | n = 75 | |
| Median (range) age, years | 59 (38–78) | 54 (31–78) | 57 (31–78) |
| Aged <65 years, n (%) | 31 (81.6) | 32 (86.5) | 63 (84.0) |
| Male, n (%) | 37 (97.4) | 34 (91.9) | 71 (94.7) |
| Region, n (%) | |||
| Mainland China | 14 (36.8) | 12 (32.4) | 26 (34.7) |
| Republic of Korea | 18 (47.4) | 19 (51.4) | 37 (49.3) |
| Taiwan | 6 (15.8) | 6 (16.2) | 12 (16.0) |
| Prior local–regional anticancer therapy, n (%) | |||
| Yes | 20 (52.6) | 20 (54.1) | 40 (53.3) |
| No | 18 (47.4) | 17 (45.9) | 35 (46.7) |
| HBV test, n (%) | |||
| Positive | 24 (63.2) | 30 (81.1) | 54 (72.0) |
| Negative | 10 (26.3) | 6 (16.2) | 16 (21.3) |
| Missing | 4 (10.5) | 1 (2.7) | 5 (6.7) |
| HCV test, n (%) | |||
| Positive | 2 (5.3) | 5 (13.5) | 7 (9.3) |
| Negative | 22 (57.9) | 21 (56.8) | 43 (57.3) |
| Missingb | 14 (36.8) | 11 (29.7) | 25 (33.3) |
| HBV/HCV at baseline, n (%) | |||
| Either positive | 24 (63.2) | 30 (81.1) | 54 (72.0) |
| Both negative or one negative/one missing | 10 (26.3) | 6 (16.2) | 16 (21.3) |
| Both missing | 4 (10.5) | 1 (2.7) | 5 (6.7) |
| Alcohol use, n (%) | |||
| Never | 13 (34.2) | 14 (37.8) | 27 (36.0) |
| Regular | 5 (13.2) | 4 (10.8) | 9 (12.0) |
| Occasional | 0 (0.0) | 1 (2.7) | 1 (1.3) |
| Former | 20 (52.6) | 18 (48.6) | 38 (50.7) |
| AFP, n (%) | |||
| ≥200 IU/mL | 22 (57.9) | 24 (64.9) | 46 (61.3) |
| <200 IU/mL | 16 (42.1) | 13 (35.1) | 29 (38.7) |
| Vascular invasion, n (%) | |||
| Yes | 12 (31.6) | 15 (40.5) | 27 (36.0) |
| No | 16 (42.1) | 6 (16.2) | 22 (29.3) |
| Missing | 10 (26.3) | 16 (43.2) | 26 (34.7) |
| BCLC stage, n (%) | |||
| B | 2 (5.3) | 2 (5.4) | 4 (5.3) |
| C | 36 (94.7) | 35 (94.6) | 71 (94.7) |
| MET IHC, n (%) | |||
| IHC 2+ | 36 (94.7) | 24 (64.9) | 60 (80.0) |
| IHC 3+ | 2 (5.3) | 13 (35.1) | 15 (20.0) |
| MET amplification,c n (%) | |||
| Present | 4 (10.5) | 5 (13.5) | 9 (12.0) |
| Absent | 32 (84.2) | 32 (86.5) | 64 (85.3) |
| Missing | 2 (5.3) | 0 (0.0) | 2 (2.7) |
AFP alpha-fetoprotein, BCLC Barcelona Clinic liver cancer, GCN gene copy number, HBV hepatitis B virus, HCV hepatitis C virus, IHC immunohistochemistry, IU international units, mITT modified intention-to-treat.
amITT excludes patients that were MET IHC 1+ or not assessable based on re-scoring.
bHCV testing was a late addition to the study protocol; therefore, HCV is missing for 25/75 patients.
cMET amplification defined as mean GCN ≥ 5.