Table 2.
Objective Responses Rates, PFS, and Overall Survival in ALTA
| Efficacy Parameter | Investigator-Assessed |
IRC-Assessed |
||
|---|---|---|---|---|
| Arm A 90 mg Once Daily (n = 112) |
Arm B 90 mg→180 mg Once Dailya (n = 110) |
Arm A 90 mg Once Daily (n = 112) |
Arm B 90 mg→180 mg Once Dailya (n = 110) |
|
| All patients | ||||
| Confirmed ORR, n (%) | 51 (46) | 63 (57) | 58 (52) | 62 (56) |
| [97.5% CI]b or [95% CI] | [35–57]b | [46–68]b | [42–61] | [47–66] |
| Confirmed CR, n (%) | 2 (2) | 5 (5) | 7 (6) | 8 (7) |
| Confirmed PR, n (%) | 49 (44) | 58 (53) | 51 (46) | 54 (49) |
| DCR, n (%) | 91 (81) | 95 (86) | 87 (78) | 92 (84) |
| [95% CI] | [73–88] | [79–92] | [69–85] | [75–90] |
| Time to response, median (range), mo | (n = 51) 1.8 (1.7–11.1) |
(n = 63) 1.9 (1.0–35.0) |
(n = 58) 1.8 (1.6–37.8) |
(n = 62) 1.9 (1.0–23.4) |
| Duration of response, median (95% CI),c mo | 12.0 (9.2–19.4) | 13.8 (10.8–17.6) | 19.4 (9.2–24.9) | 15.7 (13.6–22.1) |
| PFS | ||||
| No. of patients with events (%) | 85 (76) | 72 (65) | 73 (65) | 62 (56) |
| Median (95% CI),c mo | 9.2 (7.4–11.1) | 15.6 (11.1–18.5) | 9.9 (7.4–12.8) | 16.7 (11.6–21.4) |
| PFS probability,c % (95% CI) | ||||
| 1 y | 37 (27–46) | 58 (47–67) | 44 (34–54) | 61 (49–70) |
| 2 y | 23 (15–32) | 31 (22–42) | 34 (24–44) | 33 (22–44) |
| 3 y | 15 (8–23) | 18 (10–27) | 19 (11–29) | 24 (14–35) |
| 4 y | 9 (4–18) | 15 (8–24) | 17 (9–27) | 20 (11–31) |
| 5 y | NR | NR | 11 (4–22) | NR |
| Overall survival | Arm A (n = 112) | Arm B (n = 110) | ||
| No. of patients with events (%) | 64 (57) | 54 (49) | ||
| Median (95% CI),c mo | 25.9 (18.2–45.8) | 40.6 (32.5–NR) | ||
| Overall survival probability,c % (95% CI) | ||||
| 1 y | 70 (60–78) | 80 (71–87) | ||
| 2 y | 55 (44–64) | 67 (57–75) | ||
| 3 y | 45 (35–54) | 55 (44–64) | ||
| 4 y | 38 (28–48) | 46 (36–56) | ||
| 5 y | 31 (21–43) | 43 (33–53) | ||
CI, confidence interval; CR, complete response; DCR, disease control rate; IRC, independent review committee; NR, not reached; ORR, objective response rate; PFS, progression-free survival; PR, partial response.
a
180 mg once daily with 7-day lead-in at 90 mg.
b
Primary end point tested at 0.025 alpha level for each dose.
c
Kaplan-Meier estimates of duration of response.