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First-line IO Combination Trials in mRCC




                                                            CheckMate 214   1,2          JAVELIN Renal 101   3       KEYNOTE-426    4           IMmotion 151  5
                                                                   ITT                            ITT                      ITT                       ITT
                                                            (n=550 vs n=546)              (n=442 vs n=444)          (n=432 vs n=429)          (n=454 vs n=461)

                              mOS, months                       NR vs 37.9                     NR vs NR                 NR vs NR                  NR vs NR
                              HR (CI);                       0.71 (0.59–0.86);            0.78 (0.554–1.084);        0.53 (0.38–0.74);         0.81 (0.63–1.03)
                              P-value                             0.0003                      0.0679 (NS)                <0.0001                   0.09 (NS)

                              Landmark OS at 12                83% vs. 78%                 86% vs. 83% (est)           90% vs. 78%             80% vs. 79% (est)
                              months

                              mPFS, months                      9.7 vs 9.7                    13.8 vs 8.4              15.1 vs 11.1               11.2 vs 8.4
                              HR (CI);                       0.85 (0.73–0.98);            0.69 (0.563–0.840);        0.69 (0.57–0.84);         0.83 (0.70–0.97)
                              P-value                          0.0267 (NS)                      0.0001                    0.0001                     0.02

                              ORR, %                             41 vs 34                      51 vs 26                  59 vs 36                  37 vs 33
                              P-value                             0.0154                          NA                     <0.0001

                              CR, %                               9 vs 2                        3 vs 2                    6 vs 2                    5 vs. 2

                              mDOF, months                         32.4                      12.0 vs 11.5                  12.8                       15



                              Prognostic risk, %
                              Favorable                          23 vs 23                      21 vs 22                  32 vs 31                  20 vs 20
                              Intermediate                       61 vs 61                      61 vs 62                  55 vs 57                  71 vs 70
                              Poor                               17 vs 16                      16 vs 16                  13 vs 12                  10 vs 10
                              Randomization                Oct 2014 – Feb 2016          March 2016 – Dec 2017      Oct 2016 – Jan 2018       May 2015 – Oct 2016
                              period

                              Subsequent                      Overall (39%)                  Overall (41%)            Overall (34%)                   NR
                              therapies for sunitinib            IO (27%)                      IO (28%)                  IO (21%)
                              arm, %


                                NA=not available; NE=not estimable; NR=not reached.
                                1. Tannir NM, et al. ASCO GU 2019. Abstract 547. 2. Motzer RJ, et al. N Engl J Med. 2018; 378:1277-1290. 3. Choueiri et al. ASCO GU 2019. 4. Rini B, et al. N Engl J Med. 2018;
                                378:1277-1290. Abstract 543. 5. Motzer R, et al. ASCO GU 2018. Abstract 578.
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