Shots:
- The P-III (AMPLITUDE) trial assessed Akeega (niraparib & abiraterone acetate tablet) + prednisone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mCSPC, meeting its 1EP of improved rPFS
- In BRCA-altered pts (n=191), trial showed a 48% & 56% reduction in rPFS & symptomatic progression risk, respectively, plus a 25% decrease in death risk at interim analysis (median rPFS: not reached vs 26mos.)
- In HRR-altered pts, Akeega showed a 37% & 50% decrease in risk of progression or death & symptomatic progression, respectively, plus a 21% reduction in death risk at interim analysis (median rPFS: not reached vs 29.5mos.); follow-up is ongoing for OS data maturity
Ref: J&J| Image: J&J| Press Release
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