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 | |||
| 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 | |||
| NCT02766335 | — | Overall Response Rate Among PD-L1 Positive Participants Treated With MEDI4736 Up to 3 years post registration | Arm I (MEDI4736 - Closed to Accrual 12/2015) | 14 percentage of participants |
| NCT02766335 | — | Response Rate in MEDI4736-treated Participants Up to 3 years post registration | Arm I (MEDI4736 - Closed to Accrual 12/2015) | 16 percentage of participants |
| NCT03003962 | — | OS in Participants With LREM From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022) | Durvalumab | 14.6 months |
| Platinum-based SoC | 15.0 months | |||
| NCT03003962 | — | Overall Survival (OS) From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months [data cut-off (DCO) 27 October 2022] | Durvalumab | 14.6 months |
| Platinum-based SoC | 12.8 months | |||
| 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 | 300 participants |
| AEPI | 0 participants | |||
| AEPI | 7 participants | |||
| AEPI | 181 participants | |||
| AEPI | 119 participants | |||
| AEPI | 49 participants | |||
| AEPI | 13 participants | |||
| AEPI | 0 participants | |||
| AEPI | 145 participants | |||
| AEPI | 20 participants | |||
| AEPI | 3 participants | |||
| AESI | 12 participants | |||
| AESI | 265 participants | |||
| AESI | 21 participants | |||
| AESI | 19 participants | |||
| AESI | 1 participants | |||
| AESI | 191 participants | |||
| AESI | 15 participants | |||
| AESI | 14 participants | |||
| AESI | 1 participants | |||
| AESI | 140 participants | |||
| AESI | 124 participants | |||
| imAE | 32 participants | |||
| imAE | 10 participants | |||
| imAE | 65 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 | |||
| NCT03258554 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase] From start of durvalumab to 4 weeks after radiation therapy, approximately 13 weeks. Weekly during RT, at RT end, prior to adjuvant durvalumab, one month after end of RT. | (Lead-in) RT + Durvalumab | 0 Participants |
| NCT03258554 | Squamous Cell Carcinoma of Head and Neck | Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary] From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | RT + Durvalumab | 69.3 percentage of participants |
| RT+ Cetuximab | 77.5 percentage of participants | |||
| NCT03258554 | Squamous Cell Carcinoma of Head and Neck | Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary] From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years. | RT + Cetuximab | 63.7 percentage of participants |
| RT + Durvalumab | 50.6 percentage of participants | |||
| 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 | |||
| NCT03519971 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). | Durvalumab + SoC CRT | 13.8 months |
| Placebo + SoC CRT | 9.4 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 | |||
| NCT03706690 PACIFIC-5 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) (Modified Intent-to-Treat [mITT] Set) Tumor scans performed at screening, every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) | Durvalumab | 14.0 months |
| Placebo | 6.5 months | |||
| NCT03732677 NIAGARA | Urinary Bladder Neoplasms | Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event Up to 48 months | Durvalumab + Gemcitabine + Cisplatin | NA months |
| Gemcitabine + Cisplatin | 46.1 months | |||
| NCT03732677 NIAGARA | Urinary Bladder Neoplasms | Pathologic Complete Response (pCR) Rates at Time of Cystectomy Up to 6 months | Durvalumab + Gemcitabine + Cisplatin | 199 Participants |
| Gemcitabine + Cisplatin | 146 Participants | |||
| NCT03830866 CALLA | — | Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months | Durvalumab + SoC CCRT | NA Months |
| Placebo + SoC CCRT | NA Months | |||
| NCT03875235 TOPAZ-1 | Biliary Tract Neoplasms | Overall Survival (OS) From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off) | Durvalumab + Gemcitabine + Cisplatin | 12.8 Months |
| Placebo + Gemcitabine + Cisplatin | 11.5 Months | |||
| NCT03875235 TOPAZ-1 | Biliary Tract Neoplasms | Overall Survival (OS) Rate at 18 Months From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique. | Durvalumab + Gemcitabine + Cisplatin | 35.1 Percentage of Participants |
| Placebo + Gemcitabine + Cisplatin | 25.6 Percentage of Participants | |||
| NCT03875235 TOPAZ-1 | Biliary Tract Neoplasms | Overall Survival (OS) Rate at 24 Months From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique. | Durvalumab + Gemcitabine + Cisplatin | 24.9 Percentage of Participants |
| Placebo + Gemcitabine + Cisplatin | 10.4 Percentage of Participants | |||
| NCT04026412 CheckMate73L | Carcinoma, Non-Small-Cell Lung | Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR) From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months) | Arm A:Nivo + CCRT/Nivo + Ipi | 16.69 months |
| Arm C: CCRT/Durva | 15.64 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 | |||
| NCT04385368 MERMAID-1 | Carcinoma, Non-Small-Cell Lung | Disease-free Survival (DFS) in FAS (Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors 1.1 [RECIST 1.1]) Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months | Durvalumab + SoC | NA months |
| Placebo + SoC | NA months | |||
| NCT04449861 | — | Percentage of Participants With Grade ≥3 AEs 19 months | Durvalumab With EP | 49.7 percentage of participants |
| NCT04449861 | — | Percentage of Participants With Immune-mediated Adverse Events (imAEs) 19 months | Durvalumab With EP | 24.2 percentage of participants |
| NCT04637594 IMAGINE | Carcinoma, Transitional Cell | Overall Survival (OS) Rate at 12 Months 12 months | Arm A (Immune Checkpoint Inhibitor) | 0 percentage of participants |
| Arm B (Immune Checkpoint Inhibitor) | 0 percentage of participants | |||
| NCT04642469 MERMAID-2 | Carcinoma, Non-Small-Cell Lung | Disease-free Survival (DFS) Every 8 weeks (q8w) ± 1 week until Week 48, then every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or follow-up, up to 16.6 months | Durvalumab | 3.9 Months |
| Placebo | 2.0 Months | |||
| NCT04712903 CANTABRICO | — | Number of Patients With Adverse Events (AEs) Grade ≥ 3 During study treatment, until disease progression (median 6 months) | Experimental Arm | 24 Participants |
| Experimental Arm | 77 Participants | |||
| NCT04712903 CANTABRICO | — | Number of Patients With Immune-mediated Adverse Events (imAE) During study treatment, until disease progression (median 6 months) | Experimental Arm | 63 Participants |
| Experimental Arm | 38 Participants | |||
| NCT04774380 LUMINANCE | Small Cell Lung Carcinoma | Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs) From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years. | Durvalumab+EP | 91 Participants |
| NCT04774380 LUMINANCE | Small Cell Lung Carcinoma | Number of Participants With Incidence of Immune Mediated Adverse Events (imAEs) From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years. | Durvalumab+EP | 22 Participants |