Efficacy
Tumors, death, tumors, PD‐L1
EVENT, DISEASE, TUMORS, CPS, TUMORS
Among the 87 patients in the Japan subset, 69 (79%) had died at the time of data cutoff. In the 28 patients with PD‐L1 CPS ≥10 tumors, the median OS was 25.9 months (95% CI, 17.1 months–not reached) in the pembrolizumab plus chemotherapy group and 18.2 months (95% CI, 3.0–26.5 months) in the placebo plus chemotherapy group (HR, 0.36 [95% CI, 0.14–0.89]). The 18‐month OS rates were 74% and 56%, respectively (Figure Overall survival in (A) patients with PD‐L1 CPS ≥10 tumors, (B) patients with PD‐L1 CPS ≥1 tumors, and (C) the intention‐to‐treat population. CPS, combined positive score; HR, hazard ratio; NR, not reached; PD‐L1, programmed cell death ligand 1.Among all 87 patients in the Japan subset, 70 (80%) had experienced a PFS event at the time of data cutoff. Among patients with PD‐L1 CPS ≥10 tumors, the median PFS was 11.7 months (95% CI, 3.7–27.8 months) in the pembrolizumab plus chemotherapy group and 5.6 months (95% CI, 2.0–9.7 months) in the placebo plus chemotherapy group (HR, 0.52 [95% CI, 0.20–1.34]). The 12‐month PFS rates were 44% and 13%, respectively (Figure Progression‐free survival per RECIST version 1.1 by blinded independent central review in (A) patients with PD‐L1 CPS ≥10 tumors, (B) patients with PD‐L1 CPS ≥1 tumors, and (C) the intention‐to‐treat population. CPS, combined positive score; HR, hazard ratio; PD‐L1, programmed cell death ligand 1.Among patients with PD‐L1 CPS ≥10 tumors, the ORR per RECIST version 1.1 by blinded independent central review was 42% (95% CI, 20–67) in the pembrolizumab plus chemotherapy group and 33% (95% CI, 7–70) in the placebo plus chemotherapy group. The median duration of response was 19.3 months (range, 6.0–40.3+ months) in the pembrolizumab plus chemotherapy group and 7.3 months (range, 3.4–15.4 months) in the placebo plus chemotherapy group. In patients with PD‐L1 CPS ≥1 tumors, the ORR was 43% (95% CI, 28–59) and 50% (95% CI, 28–72) and the median duration of response was 14.9 months (range, 3.5–42.8+ months) and 6.0 months (range, 2.3–28.5 months), respectively. In the intention‐to‐treat population, the ORR was 43% (95% CI, 30–56) in the pembrolizumab plus chemotherapy group and 46% (95% CI, 27–67) in the placebo plus chemotherapy group. The median duration of response was 12.6 months (range, 3.0+ to 42.8+ months) and 6.0 months (range, 2.3–28.5 months), respectively. The disease control rates were similar between the treatment groups across all 3 populations (Table Summary of confirmed ORR per RECIST Version 1.1 by blinded independent central review.
Abbreviations: CPS, combined positive score; ORR, overall response rate; PD‐L1, programmed cell death ligand 1; RECIST, Response Evaluation Criteria in Solid Tumors.Not evaluable includes subjects with insufficient data for assessment of response per RECIST version 1.1.No assessment includes subjects without postbaseline assessment on the data cutoff date.From product‐limit (Kaplan–Meier) method for censored data.No progressive disease by the time of last disease assessment.