Table 4.
Best objective tumor response (investigator assessment) in Study 1199 by primary KIT mutational status, and in the overall ITT population of Study 1036
| Response parameter | Study 1199 | 1036 ITT (N = 1124) | |
|---|---|---|---|
| Exon 9 (n = 42) | Exon 11 (n = 143) | ||
| Best confirmed tumor response,a n (%) | |||
| CR | 2 (5) | 0 | 10 (1) |
| PR | 6 (14) | 9 (6) | 78 (7) |
| Stable disease | 29 (69) | 86 (60) | 639 (57) |
| PD | 4 (10) | 31 (22) | 237 (21) |
| Not evaluable | 0 | 1 (1) | 2 (<1) |
| Missing | 1 (2) | 16 (11) | 158 (14) |
| Confirmed objective responses,b n (%) | 8 (19) | 9 (6) | 88 (8) |
| 95 % exact CI, % | 9−34 | 3−12 | 6−10 |
| Difference in ORR: exon 9 vs. exon 11, % | 13 | NA | |
| 95 % CI | <1−25 | NA | |
| P-value (two-sided Pearson χ2) | 0.012 | NA | |
CI confidence interval, CR complete response, ITT intent-to-treat, NA not applicable, PD progressive disease, PR partial response
aTumor assessment data obtained ≤28 days after last dose of study drug
bCR + PR