Efficacy
Tumors, PD, tumor, Cancer
TUMORS, TUMOR, DISEASE, CANCER
PFS as determined by IIR per RECIST v1.1 was longer in Japanese patients randomized to the lenvatinib plus pembrolizumab arm (median, 22.1 months; 95% CI, 11.9–not estimable [NE]) versus those randomized to the sunitinib arm (median, 10.9 months; 95% CI, 5.6–11.2), with an HR of 0.39 (95% CI, 0.20–0.74) (Figure Progression‐free survival in Japanese patients by independent imaging review per RECIST v1.1. CI, confidence interval; HR, hazard ratio; L/LEN, lenvatinib; NE, not estimable; P/PEMBRO, pembrolizumab; RECIST v1.1, Response Evaluation Criteria In Solid Tumors version 1.1; S/SUN, sunitinib.Overall survival in Japanese patientsAbbreviations: CI, confidence interval; HR, hazard ratio; LEN, lenvatinib; MSKCC, Memorial Sloan‐Kettering Cancer Center; NE, not estimable; OS, overall survival; PEMBRO, pembrolizumab; SUN, sunitinib.95% CIs estimated with a generalized Brookmeyer and Crowley method.Hazard ratio based on a Cox proportional hazard model including treatment group as a factor, Efron method used for ties.Hazard ratio based on a Cox proportional hazard model including treatment group and MSKCC risk group as factors, Efron method used for ties.Summary of tumor response by independent imaging review per RECIST v1.1 in Japanese patientsAbbreviations: CI, confidence interval; CR, complete response; NE, not estimable; PR, partial response; RECIST v1.1, Response Evaluation Criteria In Solid Tumors version 1.1; SD, stable disease.95% CIs estimated with a generalized Brookmeyer and Crowley method.Patients' treatment durations and best overall tumor responses are shown in Figure Duration of treatment and tumor response by independent imaging review per RECIST v1.1. BOR, best overall response; CR, complete response; MSKCC, Memorial Sloan‐Kettering Cancer Center; NE, not evaluable; PD, progressive disease; PR, partial response; RECIST v1.1, Response Evaluation Criteria In Solid Tumors version 1.1; SD, stable disease.