Table 2.
Tumor responses as assessed by investigator using RECIST v1.1.
Parameter | Total patients (N = 31)a | PD-L1 CPS <5 (n = 20) | PD-L1 CPS ≥5 (n = 9) |
---|---|---|---|
BOR, n (%) | |||
CR | 0 | 0 | 0 |
PR | 8 (25.8) | 5 (25.0) | 2 (22.2) |
SD | 14 (45.2) | 7 (35.0) | 6 (66.7) |
PD | 8 (25.8) | 7 (35.0) | 1 (11.1) |
Unknown/not evaluable | 1 (3.2) | 1 (5.0) | 0 |
ORRb, n (%) | 8 (25.8) | 5 (25.0) | 2 (22.2) |
95% CIc | 11.9–44.6 | 8.7–49.1 | 2.8–60.0 |
DCRd, n (%) | 22 (71.0) | 12 (60.0) | 8 (88.9) |
95% CIc | 52.0–85.8 | 36.1–80.9 | 51.8–99.7 |
Note: BOR of CR or PR required confirmation by a subsequent assessment of response at least 28 days later. SD must have occurred ≥5 weeks following the first dose of the study drug to be considered the BOR.
aCPS was not available for two patients.
bORR = CR+PR.
cCI was calculated using the Clopper–Pearson exact method.
dDCR = CR+PR+SD.