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MAGNITUDE All HRR BM+: Primary Endpoint

NIRA + AAP Significantly Reduced the Risk of Progression or Death by 27%

rPFS assessed by central review rPFS assessed by investigator

100 100

Patients without events (%) 60 NIRA + AAP: 16.5 mo Patients without events (%) 60 NIRA + AAP: 19.0 mo
80
80

40
40

20

P = 0.0217
Nominal P = 0.0022
0
0 HR: 0.73 (95% CI, 0.56-0.96) PBO + AAP: 13.7 mo 20 HR: 0.64 (95% CI, 0.49-0.86) PBO + AAP: 13.9 mo
0 3 6 9 12 15 18 21 24 27 30 0 3 6 9 12 15 18 21 24 27 30
Months from randomization Months from randomization
No. at risk No. at risk
NIRA + AAP 212 192 167 129 96 64 45 21 10 2 0 NIRA + AAP 212 197 174 136 108 75 50 23 11 2 0
PBO + AAP 211 182 149 102 78 53 35 15 9 2 0 PBO + AAP 211 187 145 103 81 58 41 20 9 2 0

Median follow-up 18.6 months

AAP, abiraterone acetate + prednisone/prednisolone; BM, biomarker; CI, confidence interval; HR, hazard ratio; HRR, homologous recombination repair; NIRA, niraparib; PBO, placebo; rPFS, radiographic progression-free survival.

PRESENTED BY: Kim N. Chi, MD