Table 3 Summary of efficacy parameters by dose in patients with R/R SCLC, including those enrolled in the 1.8 mg kg−1 and 2.5 mg kg−1 dose-optimization cohorts
Part 2a 1.8 mg kg−1 (n = 41) | Part 2a 1.8 mg kg−1 2L (n = 17) | Part 2a 2.5 mg kg−1 (n = 39) | Part 1 + 2a + 2c (N = 124) | |
|---|---|---|---|---|
ORR,a n (%) | 23 (56.1) | 14 (82.4) | 23 (59.0) | 65 (52.4) |
(95% CI) | (39.7−71.5) | (56.6−96.2) | (42.1−74.4) | (44.0−62.4) |
Confirmed best response,a n (%) | ||||
CR | 3 (7.3) | 2 (11.8) | 0 | 3 (2.4) |
PR | 20 (48.8) | 12 (70.6) | 23 (59.0) | 62 (50.0) |
SD | 16 (39.0) | 2 (11.8) | 14 (35.9) | 46 (37.1) |
PD | 1 (2.4) | 1 (5.9) | 0 | 6 (4.8) |
NE | 0 | 0 | 1 (2.6) | 2 (1.6) |
NA | 1 (2.4) | 0 | 1 (2.6) | 3 (2.4) |
Clinical benefit rate,b n (%) | 39 (95.1) | 16 (94.1) | 37 (94.9) | 111 (89.5) |
(95% CI) | (83.5−99.4) | (71.3−99.9) | (82.7−99.4) | (84.4−95.4) |
Median DOR, months (95% CI) | 5.93 (3.55−11.10) | 6.57 (3.12−12.45) | 4.88 (3.52−6.87) | 5.32 (4.14−6.70) |
Median PFS, months (95% CI) | 6.44 (4.01−8.08) | 6.77 (4.01−12.45) | 5.62 (4.44−7.03) | 5.39 (4.40−5.68) |
Median OS, months (95% CI) | 12.42 (8.21−17.31) | 14.26 (7.75−NE) | 11.86 (6.74−16.69) | 11.27 (9.10−14.78) |
OS estimate at 15 months (95% CI) | 0.44 (0.27−0.59) | 0.50 (0.24−0.71) | 0.38 (0.23−0.53) | 0.40 (0.30−0.49) |
