Page 10 - Flipbook
P. 10

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.
   5   6   7   8   9   10   11   12   13   14   15