Table 1 Baseline characteristics (Phase 2 study; mITT populationa).

From: Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression

 

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)

  1. 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.
  2. amITT excludes patients that were MET IHC 1+ or not assessable based on re-scoring.
  3. bHCV testing was a late addition to the study protocol; therefore, HCV is missing for 25/75 patients.
  4. cMET amplification defined as mean GCN ≥ 5.