Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01847274 | Ovarian Neoplasms | Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days | gBRCA Niraparib | 21 months |
| gBRCA Placebo | 5.5 months | |||
| NCT01847274 | Ovarian Neoplasms | Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days | Non-gBRCAmut HRD+ Niraparib | 12.9 months |
| Non-gBRCAmut HRD+ Placebo | 3.8 months | |||
| NCT01847274 | Ovarian Neoplasms | Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days | Non-gBRCA Niraparib | 9.3 Months |
| Non-gBRCA Placebo | 3.9 Months | |||
| NCT01905592 BRAVO | Ovarian Neoplasms | Progression Free Survival (PFS) - Central Review Assessment From the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier, up to 4 years | Niraparib | 4.1 Months |
| Physician's Choice | 3.1 Months | |||
| NCT02655016 | Ovarian Neoplasms | Progression Free Survival Up to 34 months | Niraparib | 13.8 Months |
| Placebo | 8.2 Months | |||
| NCT03602859 FIRST | Ovarian Neoplasms | Progression Free Survival (PFS) Up to approximately 316 weeks | Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | 20.63 Months |
| Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2) | 19.19 Months | |||
| NCT03748641 MAGNITUDE | Prostatic Neoplasms, Castration-Resistant | Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) Up to 32 months | Cohort 1 BRCA Subgroup: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 16.56 Months |
| Cohort 1 BRCA Subgroup: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 10.87 Months | |||
| NCT03748641 MAGNITUDE | Prostatic Neoplasms, Castration-Resistant | Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) Up to 32 months | Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 16.46 Months |
| Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 13.70 Months | |||
| NCT04475939 ZEAL-1L | Carcinoma, Non-Small-Cell Lung | Progression-free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) - Complete and Partial Response (CR/PR) Population Up to 52 months | Niraparib + Pembrolizumab | 5.55 Months |
| Placebo + Pembrolizumab | 5.55 Months | |||
| NCT04497844 AMPLITUDE | — | All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator From date of randomization (Day -3 to Day 1) up to approximately 49 months | Niraparib With Abiraterone Acetate Plus Prednisone | NA months |
| Placebo With Abiraterone Acetate Plus Prednisone | 29.54 months | |||
| NCT04497844 AMPLITUDE | — | Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator From date of randomization (Day -3 to Day 1) up to approximately 49 months | BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone | NA months |
| BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone | 25.99 months | |||
| NCT04497844 AMPLITUDE | — | HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator From date of randomization (Day -3 to Day 1) up to approximately 49 months | HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone | NA months |
| HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone | 27.56 months | |||
| NCT04915755 ZEST | Breast Neoplasms | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Up to approximately 125 weeks | Niraparib | 16 Participants |
| Niraparib | 1 Participants | |||
| Niraparib | 9 Participants | |||
| Niraparib | 17 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 7 Participants | |||
| Niraparib | 2 Participants | |||
| Placebo | 4 Participants | |||
| Placebo | 11 Participants | |||
| Placebo | 6 Participants | |||
| Placebo | 17 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 9 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 16 Participants | |||
| NCT04915755 ZEST | Breast Neoplasms | Number of Participants With TEAEs Leading to Death Up to approximately 125 weeks | Niraparib | 0 Participants |
| Placebo | 0 Participants | |||
| NCT04915755 ZEST | Breast Neoplasms | Number of Participants With TEAEs Leading to Dose Modifications and Discontinuation of Study Treatment Up to approximately 125 weeks | Niraparib | 10 Participants |
| Niraparib | 11 Participants | |||
| Niraparib | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 1 Participants | |||
| NCT04915755 ZEST | Breast Neoplasms | Number of Participants With Treatment Emergent Adverse Event (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) Up to approximately 125 weeks | Niraparib | 5 Participants |
| Niraparib | 18 Participants | |||
| Niraparib | 0 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 17 Participants | |||
| NCT04915755 ZEST | Breast Neoplasms | Number of Participants With Use of Concomitant Medications Up to approximately 125 weeks | Niraparib | 18 Participants |
| Placebo | 18 Participants | |||
| NCT04915755 ZEST | Breast Neoplasms | Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline Up to approximately 125 weeks | Niraparib | 2 Participants |
| Niraparib | 1 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 4 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 8 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 12 Participants | |||
| Niraparib | 6 Participants | |||
| Niraparib | 13 Participants | |||
| Niraparib | 5 Participants | |||
| Niraparib | 6 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 14 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 12 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 4 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 4 Participants | |||
| Niraparib | 11 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 5 Participants | |||
| Niraparib | 10 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 14 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 11 Participants | |||
| Niraparib | 6 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 13 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 5 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 8 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 7 Participants | |||
| Niraparib | 11 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 2 Participants | |||
| Niraparib | 12 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 6 Participants | |||
| Niraparib | 11 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 12 Participants | |||
| Niraparib | 6 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 15 Participants | |||
| Placebo | 19 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 15 Participants | |||
| Placebo | 5 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 18 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 16 Participants | |||
| Placebo | 4 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 7 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 18 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 9 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 18 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 18 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 4 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 14 Participants | |||
| Placebo | 4 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 17 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 13 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 13 Participants | |||
| Placebo | 6 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 4 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 7 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 10 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 16 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 17 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 6 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 13 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 1 Participants | |||
| NCT04915755 ZEST | Breast Neoplasms | Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline Up to approximately 125 weeks | Niraparib | 9 Participants |
| Niraparib | 12 Participants | |||
| Niraparib | 9 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 9 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 5 Participants | |||
| Niraparib | 10 Participants | |||
| Niraparib | 10 Participants | |||
| Niraparib | 8 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 9 Participants | |||
| Niraparib | 8 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 8 Participants | |||
| Niraparib | 7 Participants | |||
| Niraparib | 4 Participants | |||
| Niraparib | 3 Participants | |||
| Niraparib | 12 Participants | |||
| Niraparib | 9 Participants | |||
| Niraparib | 9 Participants | |||
| Niraparib | 13 Participants | |||
| Niraparib | 4 Participants | |||
| Niraparib | 9 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 4 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 21 Participants | |||
| Placebo | 21 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 19 Participants | |||
| Placebo | 15 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 3 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 16 Participants | |||
| Placebo | 19 Participants | |||
| Placebo | 6 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 21 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 14 Participants | |||
| Placebo | 6 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 15 Participants | |||
| Placebo | 17 Participants | |||
| Placebo | 6 Participants | |||
| Placebo | 1 Participants | |||
| NCT04915755 ZEST | Breast Neoplasms | Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline Up to approximately 125 weeks | Niraparib | 0 Participants |
| Niraparib | 13 Participants | |||
| Niraparib | 18 Participants | |||
| Niraparib | 9 Participants | |||
| Niraparib | 5 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 0 Participants | |||
| Niraparib | 1 Participants | |||
| Niraparib | 12 Participants | |||
| Niraparib | 6 Participants | |||
| Niraparib | 8 Participants | |||
| Niraparib | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 16 Participants | |||
| Placebo | 21 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 21 Participants | |||
| Placebo | 4 Participants | |||
| Placebo | 0 Participants | |||
| Placebo | 22 Participants | |||
| Placebo | 0 Participants |