Table 3.
Best overall response as determined by IRC (Phase 2 study; mITT analysis set).
| 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 |
CI confidence interval, CMH Cochran–Mantel–Haenszel, IRC independent review committee, mITT modified intention-to-treat.
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).
b90% CI using the Newcombe–Wilson method.