Overall objective response by KRAS status (central assessment)
Low/Negative EGFR | High EGFR | |||||
---|---|---|---|---|---|---|
All patients | WT KRAS* | MT KRAS* | All patients | WT KRAS | MT KRAS | |
KRAS ITT analysis sets, n | 203 | 94 | 77 | 185 | 86 | 82 |
Best objective response,† n (%) | ||||||
Partial response | 8 (4) | 8 (9) | 0 | 5 (3) | 5 (6) | 0 |
Stable disease‡ | 65 (32) | 44 (47) | 7 (9) | 43 (23) | 30 (35) | 9 (11) |
Disease progression | 101 (50) | 32 (34) | 56 (73) | 106 (57) | 40 (47) | 57 (70) |
Unevaluable/Not done | 29 (14) | 10 (10) | 14 (18) | 31 (17) | 11 (12) | 16 (19) |
Response rate (%) | 3.9 | 8.5 | 0 | 2.7 | 5.8 | 0 |
95% CI§ | 1.7-7.6 | 3.7-16.1 | 0.0-4.7 | 0.9-6.2 | 1.9-13.0 | 0.0-4.4 |
↵*Patients without available EGFR status (n = 8) and with EGFR ≥10% (n = 3) in the Low/Negative EGFR study were included in the KRAS subsets.
↵†Analysis based on assessments from a blinded central review of scans using modified WHO criteria.
↵‡Three additional patients without EGFR status in the Low/Negative EGFR study also had stable disease through week 16.
↵§Confidence intervals are based on the exact binomial probability (15).