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 |
|---|---|---|---|---|
| NCT01968213 ARIEL3 | Ovarian Neoplasms | Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years. | Placebo Tablets | 5.4 Months |
| Rucaparib 600 mg Tablets | 10.8 Months | |||
| NCT02855944 | Ovarian Neoplasms | Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population) Assessments every 8 weeks from Cycle 1 Day 1 (C1D1) until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years. | Chemotherapy | 5.7 Months |
| Rucaparib | 7.4 Months | |||
| NCT02855944 | Ovarian Neoplasms | Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population) Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years. | Chemotherapy | 5.7 Months |
| Rucaparib | 7.4 Months | |||
| NCT02975934 TRITON3 | — | Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) | Abiraterone Acetate or Enzalutamide or Docetaxel | 6.4 months |
| Rucaparib | 11.2 months | |||
| NCT02975934 TRITON3 | — | Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined From enrollment to primary completion of study (Total follow-up was up to approximately 4 years) | Abiraterone Acetate or Enzalutamide or Docetaxel | 6.4 months |
| Rucaparib | 10.2 months | |||
| NCT03522246 ATHENA | Fallopian Tube Neoplasms | Combination Therapy Arm A and Arm B: Investigator Assessed PFS From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | Arm A: Rucaparib + Nivolumab | 15.0 months |
| Arm B: Rucaparib + Placebo | 20.2 months | |||
| NCT03522246 ATHENA | Fallopian Tube Neoplasms | Monotherapy Arm B and Arm D: Investigator Assessed PFS From randomization until disease progression (up to the primary data analysis at approximately 39 months) | Arm B: Rucaparib + Placebo | 20.2 months |
| Arm D: Placebo + Placebo | 9.2 months | |||
| NCT03522246 ATHENA | Fallopian Tube Neoplasms | Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) From randomization until disease progression (up to the primary data analysis at approximately 39 months) | Arm B: Rucaparib + Placebo | 28.7 months |
| Arm D: Placebo + Placebo | 11.3 months | |||
| NCT04676334 CATCH-R | Ovarian Neoplasms | Number of Participants Experiencing SAEs and AESIs From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months) | Rucaparib | 2 Participants |
| Rucaparib | 0 Participants |