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Key Secondary Endpoint: OS, ITT Population
100 24-mo rate
90
96.2%
80 93.8%
70
OS, % 60 Pembro Pts w/ Event Median, mo (95% CI)
50
23
NR (NR–NR)
40
30 Placebo 43 NR (NR–NR)
HR 0.52 (95% CI 0.31–0.86); P = 0.0048
20
Pembro
10
Placebo
0
0 5 10 15 20 25 30 35 40 45 50
Months
No. at risk
Pembro 496 489 485 482 477 360 231 146 63 8 0
Placebo 498 494 486 481 474 352 219 138 61 9 0
• P-value did not cross the prespecified boundary for statistical significance of 0.000095 (one-sided)
• Final analysis for OS to occur after approximately 200 OS events; only 66 events had accrued for this updated analysis
ITT population included all randomized participants. NR, not reached. Data cutoff date: June 14, 2021.