Table 3 Best overall response as determined by IRC (Phase 2 study; mITT analysis set).

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

 

Tepotinib

Sorafenib

n = 38

n = 37

Best overall response

 Complete response

0 (0.0)

0 (0.0)

 Partial response

4 (10.5)

0 (0.0)

 Non-complete response/non-partial responsea

2 (5.3)

0 (0.0)

 Stable disease

15 (39.5)

8 (21.6)

 Progressive disease

13 (34.2)

25 (67.6)

 Not evaluable

4 (10.5)

4 (10.8)

Objective response rate, n (%)

4 (10.5)

0 (0.0)

 90% CI,b %

4.8, 21.5

0.0, 6.8

 P value (CMH test)

   0.0438

Disease control rate, n (%)

19 (50.0)

8 (21.6)

 90% CI,b %

37.1, 62.9

12.6, 34.5

  1. CI confidence interval, CMH Cochran–Mantel–Haenszel, IRC independent review committee, mITT modified intention-to-treat.
  2. aNon-complete response/non-partial response was defined as persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level, if measured, above the normal limits (possible only for patients without measureable disease at baseline).
  3. b90% CI using the Newcombe–Wilson method.
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