TABLE 2.

Antitumor Activity in the Intention-to-Treat Population at Interim Analysis

Response	Lenvatinib + Pembrolizumab + Chemotherapy (n = 443)	Chemotherapy (n = 437)
Objective response rate, No. (%) 95% CIa	257 (58.0) 53.3 to 62.7	192 (43.9) 39.2 to 48.7
Difference, % (95% CI); P	14.2 (7.7 to 20.6);b P < .0001c
Best overall response, No. (%)
Complete response	38 (8.6)	22 (5.0)
PR	219 (49.4)	170 (38.9)
Stable disease	140 (31.6)	168 (38.4)
Progressive disease	18 (4.1)	39 (8.9)
Not evaluable/no assessment	28 (6.3)	38 (8.7)
Response duration, months, median (range)	8.9 (1.0+ to 27.7+)	6.8 (1.0+ to 25.8+)
Response duration ≥24 months,d %	29.7	8.7

NOTE. + indicates no progressive disease by the time of last assessment.

Abbreviations: BICR, blinded independent central review; PR, partial response.

^a Participants with confirmed complete response or PR by BICR per RECIST v1.1. Percentages were calculated using all randomly assigned participants.

^b Based on the Miettinen and Nurminen method stratified by region, performance status, and chemotherapy.

^c One-sided P value for testing.

^d From the Kaplan-Meier method for censored data.