Table 3.
Response Rates in the Efficacy Population
| End Point | Overalla |
T790M Mutation–Positive |
T790M Mutation–Negative |
T790 Mutation Unknown |
||||
|---|---|---|---|---|---|---|---|---|
| Rociletinibb (n = 75) | Chemotherapy (n = 73) | Rociletinibb (n = 25) | Chemotherapy (n = 20) | Rociletinibb (n = 36) | Chemotherapy (n = 41) | Rociletinibb (n = 14) | Chemotherapy (n = 12) | |
| Confirmed ORR,c n (%) [95% CI] | 13 (17.3) [9.6–27.8] | 6 (8.2) [3.1–17.0] | 9 (36.0) [18.0–57.5] | 3 (15.0) [3.2–37.9] | 3 (8.3) [1.8–22.5] | 2 (4.9) [0.6–16.5] | 1 (7.1) [0.2–33.9] | 1 (8.3) [0.2–38.5] |
| Best overall confirmed response, n (%) | ||||||||
| CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PR | 13 (17.3) | 6 (8.2) | 9 (36.0) | 3 (15.0) | 3 (8.3) | 2 (4.9) | 1 (7.1) | 1 (8.3) |
| SD | 44 (58.7) | 28 (38.4) | 12 (48.0) | 7 (35.0) | 25 (69.4) | 12 (29.3) | 7 (50.0) | 9 (75.0) |
| PD | 11 (14.7) | 31 (42.5) | 3 (12.0) | 8 (40.0) | 4 (11.1) | 21 (51.2) | 4 (28.6) | 2 (16.7) |
| NE | 7 (9.3) | 8 (11.0) | 1 (4.0) | 2 (10.0) | 4 (11.1) | 6 (14.6) | 2 (14.3) | 0 |
| Median duration of response (95% CI), mo | 11.0 (4.3–13.7) | 6.8 (4.5–NA) | 12.3 (2.5–22.1) | NA (4.5–NA) | 5.5 (2.8–13.1) | NA (5.8–NA) | 4.3d | 6.8d |
CI, confidence interval; CR, complete response; NA, not assessable; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors version 1.1; SD, stable disease.
a
Includes patients with unevaluable T790M mutation status.
b
Rociletinib 500-mg twice daily and 625-mg twice-daily dosage groups were pooled for this analysis.
c
Assessed according to RECIST.
d
No 95% CI interval as n = 1.