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 |
|---|---|---|---|---|
| NCT02352948 ARCTIC | — | Overall Survival (OS) From randomization (Day 1) until death due to any cause, approximately 36 months | Sub-study A: Durvalumab | 11.7 months |
| Sub-study A: SoC | 6.8 months | |||
| Sub-study B: Durvalumab+Tremelimumab | 11.5 months | |||
| Sub-study B: SoC | 8.7 months | |||
| NCT02352948 ARCTIC | — | Progression-Free Survival (PFS) Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years. | Sub-study A: Durvalumab | 3.8 months |
| Sub-study A: SoC | 2.2 months | |||
| Sub-study B: Durvalumab+Tremelimumab | 3.5 months | |||
| Sub-study B: SoC | 3.5 months | |||
| NCT02369874 EAGLE | Head and Neck Neoplasms | Overall Survival (OS) September 2015 to September 2018 (36 months) | Durvalumab | 7.6 Months |
| Durvalumab + Tremelimumab | 6.5 Months | |||
| Standard of Care (SoC) | 8.3 Months | |||
| NCT02453282 MYSTIC | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years). | Durvalumab + Tremelimumab | 11.9 months |
| Durvalumab Monotherapy | 16.3 months | |||
| SoC Chemotherapy | 12.9 months | |||
| NCT02453282 MYSTIC | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years). | Durvalumab + Tremelimumab | 3.9 months |
| SoC Chemotherapy | 5.4 months | |||
| NCT02516241 | — | To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). | Combination Therapy | 15.1 Months |
| Standard of Care | 12.1 Months | |||
| NCT02516241 | — | To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). | Monotherapy | 14.4 Months |
| Standard of Care | 12.1 Months | |||
| NCT02542293 NEPTUNE | — | OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months). | China: Durvalumab + Tremelimumab | 15.0 months |
| China: SoC Chemotherapy | 11.7 months | |||
| NCT02542293 NEPTUNE | — | Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months). | Global: Durvalumab + Tremelimumab | 11.7 months |
| Global: SoC Chemotherapy | 9.1 months | |||
| NCT02551159 KESTREL | Squamous Cell Carcinoma of Head and Neck | Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup From date of randomization until time of final analysis, an average of approximately 4 years | Durvalumab | 10.9 Months |
| Durvalumab + Tremelimumab | 11.2 Months | |||
| Standard of Care (SOC) | 10.9 Months | |||
| NCT02551159 KESTREL | Squamous Cell Carcinoma of Head and Neck | Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) From date of randomization until time of final analysis, an average of approximately 4 years | Durvalumab | 1 Participants |
| Durvalumab | 84 Participants | |||
| Durvalumab | 14 Participants | |||
| Durvalumab + Tremelimumab | 1 Participants | |||
| Durvalumab + Tremelimumab | 27 Participants | |||
| Durvalumab + Tremelimumab | 162 Participants | |||
| Standard of Care (SOC) | 14 Participants | |||
| Standard of Care (SOC) | 3 Participants | |||
| Standard of Care (SOC) | 77 Participants | |||
| NCT03043872 CASPIAN | Small Cell Lung Carcinoma | OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months). | China Cohort: D + EP | 14.4 months |
| China Cohort: EP | 10.9 months | |||
| NCT03043872 CASPIAN | Small Cell Lung Carcinoma | OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months). | China Cohort: D + EP | 14.4 months |
| China Cohort: D + T + EP | 16.1 months | |||
| China Cohort: EP | 10.9 months | |||
| NCT03043872 CASPIAN | Small Cell Lung Carcinoma | OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | Global Cohort: D + EP | 12.9 months |
| Global Cohort: D + T + EP | 10.4 months | |||
| Global Cohort: EP | 10.5 months | |||
| NCT03043872 CASPIAN | Small Cell Lung Carcinoma | Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months). | Global Cohort: D + EP | 13.0 months |
| Global Cohort: EP | 10.3 months | |||
| NCT03084471 STRONG | Diabetes Mellitus, Insulin-Dependent, 12 | Number of Participants With Adverse Events of Special Interest (AESIs) From screening to safety follow up visit (90 days after last dose), up to approximately 3 years. | AEPI | 181 participants |
| AEPI | 300 participants | |||
| AEPI | 49 participants | |||
| AEPI | 13 participants | |||
| AEPI | 0 participants | |||
| AEPI | 145 participants | |||
| AEPI | 20 participants | |||
| AEPI | 3 participants | |||
| AEPI | 0 participants | |||
| AEPI | 7 participants | |||
| AEPI | 119 participants | |||
| AESI | 21 participants | |||
| AESI | 19 participants | |||
| AESI | 1 participants | |||
| AESI | 12 participants | |||
| AESI | 15 participants | |||
| AESI | 140 participants | |||
| AESI | 191 participants | |||
| AESI | 1 participants | |||
| AESI | 124 participants | |||
| AESI | 14 participants | |||
| AESI | 265 participants | |||
| imAE | 65 participants | |||
| imAE | 32 participants | |||
| imAE | 10 participants | |||
| imAE | 0 participants | |||
| imAE | 10 participants | |||
| imAE | 16 participants | |||
| imAE | 87 participants | |||
| imAE | 0 participants | |||
| imAE | 11 participants | |||
| imAE | 17 participants | |||
| imAE | 97 participants | |||
| NCT03164616 POSEIDON | — | Overall Survival (OS); D + SoC Compared With SoC Alone From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months). | D + SoC | 13.3 months |
| SoC Alone | 11.7 months | |||
| NCT03164616 POSEIDON | — | Progression-Free Survival (PFS); D + SoC Compared With SoC Alone Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | D + SoC | 5.5 months |
| SoC Alone | 4.8 months | |||
| NCT03298451 HIMALAYA | Carcinoma, Hepatocellular | Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months). | Durva 1500 mg | 16.56 months |
| Sora 400 mg | 13.77 months | |||
| Treme 300 mg x1 Dose + Durva 1500 mg | 16.43 months | |||
| Treme 75 mg x4 Doses + Durva 1500 mg | 16.36 months | |||
| NCT03703297 ADRIATIC | Lung Neoplasms | Durvalumab Versus Placebo: Overall Survival (OS) From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) | Durvalumab | 55.9 months |
| Placebo | 33.4 months | |||
| NCT03703297 ADRIATIC | Lung Neoplasms | Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) | Durvalumab | 16.6 months |
| Placebo | 9.2 months |