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 |
|---|---|---|---|---|
| NCT01844986 SOLO-1 | Ovarian Neoplasms | Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018 | Olaparib 300mg Tablets (China Cohort) | NA Months |
| Olaparib 300mg Tablets (Global Cohort) | NA Months | |||
| Placebo Tablets (China Cohort) | 9.3 Months | |||
| Placebo Tablets (Global Cohort) | 13.8 Months | |||
| NCT01874353 | Ovarian Neoplasms | Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months. | Olaparib 300mg Tablets (China Cohort) | 13.8 Months |
| Olaparib 300mg Tablets (Global Cohort) | 19.1 Months | |||
| Placebo Tablets (China Cohort) | 5.5 Months | |||
| Placebo Tablets (Global Cohort) | 5.5 Months | |||
| NCT01924533 | Stomach Neoplasms | Overall Survival Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years | Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 82 participants |
| Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | 19 participants | |||
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 11 participants | |||
| Placebo Tablets bd + Paclitaxel 80 mg/m^2 | 62 participants | |||
| NCT02000622 OlympiAD | Breast Neoplasms | Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. | Chemotherapy | 4.2 Months |
| Olaparib 300 mg bd | 7.0 Months | |||
| NCT02032823 OlympiA | Breast Neoplasms | Invasive Disease Free Survival (IDFS) From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months) | Olaparib | 106 Participants |
| Placebo | 178 Participants | |||
| NCT02184195 POLO | Pancreatic Neoplasms | Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1) Up to 4 years | Olaparib 300 mg Twice Daily (bd) | 7.4 Months |
| Placebo | 3.8 Months | |||
| NCT02282020 SOLO3 | Ovarian Neoplasms | Objective Response Rate (ORR) RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months) | Olaparib 300 mg BID | 109 Count of Participants |
| Single Agent Chemotherapy | 37 Count of Participants | |||
| NCT02446600 | Ovarian Neoplasms | Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months. | Arm I (Platinum-based Chemotherapy) | 10.3 months |
| Arm II (Olaparib) | 8.2 months | |||
| Arm III (Olaparib, Cediranib Maleate) | 10.4 months | |||
| NCT02502266 | Ovarian Neoplasms | Overall Survival (OS) (Phase III Only) Time from study enrollment to death due to any cause, assessed up to 5 years | Arm I (Reference Regimen) | 13.6 months |
| Arm II (Cediranib Maleate, Olaparib) | 12.8 months | |||
| Arm III (Cediranib Maleate) | 10.5 months | |||
| Arm V: (Arm I Regimen: JP Patients Enrolled After P3 Cutoff) | 14.9 months | |||
| Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff) | 18.0 months | |||
| Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff) | 5.8 months | |||
| NCT02502266 | Ovarian Neoplasms | Progression-free Survival (PFS) (Phase II Only) The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months. | Arm I (Reference Regimen) | 2.3 Months |
| Arm II (Cediranib Maleate, Olaparib) | 6.2 Months | |||
| Arm III (Cediranib Maleate) | 3.4 Months | |||
| Arm IV (Olaparib) (Phase II Only) | 2.3 Months | |||
| NCT02502266 | Ovarian Neoplasms | Progression-free Survival (PFS) (Phase III Only) The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months. | Arm I (Reference Regimen) | 3.4 months |
| Arm II (Cediranib Maleate, Olaparib) | 5.2 months | |||
| Arm III (Cediranib Maleate) | 4.0 months | |||
| Arm V: (Arm 1 Regimen: JP Patients Enrolled After P3 Cutoff) | 4.2 months | |||
| Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff) | 5.3 months | |||
| Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff) | 4.1 months | |||
| NCT02987543 | — | Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). | Cohort A Investigators Choice of NHA | 3.55 Months |
| Cohort A Olaparib 300mg bd | 7.39 Months | |||
| NCT03106987 OReO | Ovarian Neoplasms | Efficacy: Progression-free Survival (PFS) At randomization visit and at every 12 weeks (+/- 7 days) until objective radiological disease progression as determined by the investigator or other discontinuation criteria are met (assessed upto 3.8 years) | Olaparib (BRCA1/2 -ve) | 5.3 Months |
| Olaparib (BRCA1/2 +ve) | 4.3 Months | |||
| Placebo (BRCA1/2 -ve) | 2.8 Months | |||
| Placebo (BRCA1/2 +ve) | 2.8 Months | |||
| NCT03286842 | — | Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants At every visit until the earliest of disease progression, death or end of study (up to 3 years) | Olaparib gBRCAm Cohort | 8.18 months |
| NCT03402841 OPINION | Ovarian Neoplasms | Progression Free Survival (PFS) Up to maximum of 32 months | Olaparib | 9.2 months |
| NCT03732820 | — | Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment Assessed from date of randomisation to data cut off (DCO1): 30Jul2021 (Approx. 2 years 9 months) | Olaparib 300 mg bd + Abiraterone 1000 mg qd | 168 Participants |
| Placebo bd + Abiraterone 1000 mg qd | 226 Participants | |||
| NCT03740165 | Ovarian Neoplasms | PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants Up to approximately 67 months | Carboplatin + Paclitaxel | 14.6 Months |
| Carboplatin + Paclitaxel + Pembrolizumab | 15.2 Months | |||
| Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 22.2 Months | |||
| NCT03740165 | Ovarian Neoplasms | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10) Up to approximately 67 months | Carboplatin + Paclitaxel | 15.2 Months |
| Carboplatin + Paclitaxel + Pembrolizumab | 17.3 Months | |||
| Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | 23.9 Months | |||
| NCT03834519 KEYLYNK-010 | Prostatic Neoplasms | Overall Survival (OS) Up to ~31 months | Next-generation Hormonal Agent Monotherapy (NHA) | 14.6 Months |
| Pembrolizumab + Olaparib | 15.8 Months | |||
| NCT03834519 KEYLYNK-010 | Prostatic Neoplasms | Radiographic Progression-Free Survival (rPFS) Up to ~26 months | Next-generation Hormonal Agent Monotherapy (NHA) | 4.2 Months |
| Pembrolizumab + Olaparib | 4.4 Months | |||
| NCT03976323 | Parkinson Disease 4, Autosomal Dominant Lewy Body | Overall Survival (OS) Up to ~51 months | Pembrolizumab + Olaparib (Maintenance Phase) | 20.7 Months |
| Pembrolizumab + Pemetrexed (Maintenance Phase) | 23.0 Months | |||
| NCT03976323 | Parkinson Disease 4, Autosomal Dominant Lewy Body | Progression-free Survival (PFS) Up to ~31 months | Pembrolizumab + Olaparib (Maintenance Phase) | 7.1 Months |
| Pembrolizumab + Pemetrexed (Maintenance Phase) | 8.3 Months | |||
| NCT03976362 | Carcinoma | Overall Survival (OS) Up to approximately 46 months | Pembro + Olaparib (Maintenance Phase) | 19.1 Months |
| Pembro + Placebo (Maintenance Phase) | 18.6 Months | |||
| NCT03976362 | Carcinoma | Progression-free Survival (PFS) Up to approximately 39 months | Pembro + Olaparib (Maintenance Phase) | 8.3 Months |
| Pembro + Placebo (Maintenance Phase) | 5.4 Months | |||
| NCT04269200 DUO-E | Endometrial Neoplasms | Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months | China Cohort - SoC | 9.7 Months |
| China Cohort - SoC + Durvalumab | 9.9 Months | |||
| China Cohort - SoC + Durvalumab + Olaparib | 9.9 Months | |||
| Global Cohort - SoC | 9.6 Months | |||
| Global Cohort - SoC + Durvalumab | 10.2 Months | |||
| Global Cohort - SoC + Durvalumab + Olaparib | 15.1 Months | |||
| NCT04456699 | Colorectal Neoplasms | Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) Up to approximately 30 months | Bevacizumab + Chemotherapy | 5.5 Months |
| Olaparib | 3.6 Months | |||
| Olaparib + Bevacizumab | 3.7 Months | |||
| NCT05171816 | — | Radiological Progression Free Survival (rPFS) Tumour imaging CT/MRI and bone scan were assessed every 8 weeks from randomisation to week 24 and then every 12 weeks until RECIST progression. Patients were followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum | Olaparib 300 mg bd + Abiraterone 1000 mg qd | 14.75 Months |
| Placebo bd + Abiraterone 1000 mg qd | NA Months | |||
| NCT05432791 | — | Progression Free Survival (PFS) (Phase II) Time between the date of randomization and the earliest of disease progression or death, assessed up to 1 year | Arm 1 (Olaparib, Temozolomide) | 3.2 Months |
| Arm 2 (Trabectedin, Pazopanib) | 5.6 Months |