Tremelimumab

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Imjudo, Tremelimumab-actl

ASTRAZENECA PLC AZN · Hepatocellular Carcinoma; Advanced Hepatocellular Carcinoma; Advanced Solid Malignancies; Metastatic Urothelial Cancer; Muscle Invasive Bladder Cancer

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    17

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    BLA761270,

Recalls, shortages, patents and EU status at a glance

Key information

Indications
Hepatocellular Carcinoma; Advanced Hepatocellular Carcinoma; Advanced Solid Malignancies; Metastatic Urothelial Cancer; Muscle Invasive Bladder Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 CompletedFirst trial start 13 Jan 201517 linked trials
  5. Filed Completed
  6. Approved Current stageFirst approval 21 Oct 2022

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Tremelimumab. Editors add each one with its source.

Filed application

No filed application is on record for Tremelimumab. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Tremelimumab.

Clinical trials

Trials linked to Tremelimumab
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06921785ClinicalTrials.gov record for NCT06921785 (opens in a new tab)ARTEMIDE-HCC01Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular CarcinomaPhase 3Recruiting1,220 (estimated)15 Mar 2030 (estimated) No
NCT05883644ClinicalTrials.gov record for NCT05883644 (opens in a new tab)SIERRADurvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)Phase 3Active, not recruiting111 (actual)30 Mar 2026 (actual) No

Publications listing SIERRA (1), newest first

  1. First-line durvalumab and tremelimumab in poor-prognosis unresectable hepatocellular carcinoma: Phase IIIb single-arm SIERRA study.

    Journal of hepatology · 2026 Oct 6

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT05557838ClinicalTrials.gov record for NCT05557838 (opens in a new tab)TREMENDOUSDurvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCCPhase 3Active, not recruiting214 (actual)30 Sep 2026 (estimated) No
NCT05301842ClinicalTrials.gov record for NCT05301842 (opens in a new tab)EMERALD-3Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCCPhase 3Active, not recruiting760 (actual)23 Feb 2026 (actual) No

Publications listing EMERALD-3 (1), newest first

  1. Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study.

    The Lancet. Oncology · 2026 Sep

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT04960709ClinicalTrials.gov record for NCT04960709 (opens in a new tab)VOLGATreatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse CisplatinPhase 3Active, not recruiting712 (actual)2 Mar 2026 (actual) No
NCT03682068ClinicalTrials.gov record for NCT03682068 (opens in a new tab)NILEStudy of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial CancerPhase 3Active, not recruiting1,246 (actual)1 Jun 2026 (actual) No

Publications listing NILE (1), newest first

  1. Immunotherapy Plus Chemotherapy Versus Chemotherapy Alone as First-Line Treatment for Advanced Urothelial Cancer: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Clinical genitourinary cancer · 2024 Oct

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT03703297ClinicalTrials.gov record for NCT03703297 (opens in a new tab)ADRIATICStudy of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation TherapyPhase 3Active, not recruiting730 (actual)15 Jan 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03703297 (opens in a new tab)

Posted results on ClinicalTrials.gov for ADRIATIC

  • Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (months)
    • Durvalumab vs Placebo: Hazard Ratio (HR) 0.76 (95% CI 0.606 to 0.950), p-value 0.01608, Log Rank, superiority
  • Durvalumab Versus Placebo: Overall Survival (OS) (months)
    • Durvalumab vs Placebo: Hazard Ratio (HR) 0.73 (95% CI 0.569 to 0.928), p-value 0.01042, Log Rank, superiority

Serious adverse events (From first dose of study drug(Day 1)upto DCO date 15 January 2024(maximum of approximately 1936 days).Safety population:all participants who received at least 1 dose of study drug.Based on results of secondary objectives at interim analysis(reviewed by unblinded IDMC),data for D+T arm were to remain blinded to Sponsor as pre-specified in study's unblinding plan.Since D+T arm was blinded at time of posting results from this interim analysis,results for that arm will be posted at final analysis.): Durvalumab 78 of 262; Durvalumab Plus Tremelimumab 0 of 0; Placebo 64 of 265

Source: ClinicalTrials.gov results for NCT03703297 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing ADRIATIC (5), newest first

  1. Population Pharmacokinetics and Exposure-response Analysis of Durvalumab in Patients with Limited-stage Small-cell Lung Cancer in the Phase 3 ADRIATIC Study.

    The AAPS journal · 2026 Sep 28

  2. Durvalumab Consolidation in Limited-Stage SCLC: Outcomes by Prior Concurrent Chemoradiotherapy and Prophylactic Cranial Irradiation in the Phase 3 ADRIATIC Trial.

    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026 Aug

  3. Durvalumab Post Concurrent Chemoradiotherapy in Japanese Patients With Limited-Stage Small-Cell Lung Cancer in the Phase 3 ADRIATIC Trial.

    Cancer science · 2025 Nov

  4. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer.

    The New England journal of medicine · 2024 Oct 10

  5. Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study.

    Clinical lung cancer · 2020 Mar

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT03298451ClinicalTrials.gov record for NCT03298451 (opens in a new tab)HIMALAYAStudy of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular CarcinomaPhase 3Active, not recruiting1,324 (actual)27 Aug 2021 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03298451 (opens in a new tab)

Posted results on ClinicalTrials.gov for HIMALAYA

  • Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg (months)
    • Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg: Estimate not given, p-value 0.0035, Log Rank, superiority
    • Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg: Hazard Ratio (HR) 0.78 (95% CI 0.66 to 0.92), Regression, Cox, superiority

Serious adverse events (All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).): Durva 1500 mg 115 of 388; Treme 300 mg x1 Dose + Durva 1500 mg 157 of 388; Treme 75 mg x4 Doses + Durva 1500 mg 52 of 152; Sora 400 mg 111 of 374

Source: ClinicalTrials.gov results for NCT03298451 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing HIMALAYA (8), newest first

  1. Plain language summary of five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (liver cancer).

    Future oncology (London, England) · 2026 May

  2. Early Safety Results from the Phase 3b SIERRA Study of Durvalumab and Tremelimumab as First-Line Treatment for Participants with Unresectable Hepatocellular Carcinoma and a Poor Prognosis.

    Liver cancer · 2025 Dec 18

  3. Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC.

    Journal of hepatology · 2025 Oct

  4. Outcomes in the Asian subgroup of the phase III randomised HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma.

    Journal of hepatology · 2025 Feb

  5. Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 Aug 10

All 8 publications for NCT03298451

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT03084471ClinicalTrials.gov record for NCT03084471 (opens in a new tab)STRONGAn Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.Phase 3Completed867 (actual)31 Mar 2020 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03084471 (opens in a new tab)

Posted results on ClinicalTrials.gov for STRONG

Serious adverse events (From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.): Durvalumab 254 of 867

Source: ClinicalTrials.gov results for NCT03084471 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing STRONG (1), newest first

  1. Primary results of STRONG: An open-label, multicenter, phase 3b study of fixed-dose durvalumab monotherapy in previously treated patients with urinary tract carcinoma.

    European journal of cancer (Oxford, England : 1990) · 2022 Mar

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT03164616ClinicalTrials.gov record for NCT03164616 (opens in a new tab)POSEIDONStudy of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).Phase 3Active, not recruiting1,186 (actual)12 Mar 2021 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03164616 (opens in a new tab)

Posted results on ClinicalTrials.gov for POSEIDON

  • Progression-Free Survival (PFS); D + SoC Compared With SoC Alone (months)
    • D + SoC vs SoC Alone: Hazard Ratio (HR) 0.74 (95% CI 0.620 to 0.885), p-value 0.00093, Log Rank, superiority
  • Overall Survival (OS); D + SoC Compared With SoC Alone (months)
    • D + SoC vs SoC Alone: Hazard Ratio (HR) 0.86 (95% CI 0.724 to 1.016), p-value 0.07581, Log Rank, superiority

Serious adverse events (Adverse events: from first dose of study treatment until the earlier of 90 days after last dose or the date of first subsequent anticancer therapy. All-cause mortality (death due to any cause): from randomization up to global cohort final analysis DCO (12 March 2021). Maximum timeframe of approximately 45 months.): T + D + SoC 146 of 330; D + SoC 134 of 334; SoC Alone 117 of 333

Source: ClinicalTrials.gov results for NCT03164616 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing POSEIDON (3), newest first

  1. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy in First-Line Metastatic NSCLC: Five-Year Overall Survival Outcomes From the Phase 3 POSEIDON Trial.

    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025 Jan

  2. Population Pharmacokinetics and Exposure-Response Analysis for the CTLA-4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study.

    Clinical pharmacology and therapeutics · 2023 Dec

  3. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 Feb 20

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT03043872ClinicalTrials.gov record for NCT03043872 (opens in a new tab)CASPIANDurvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)Phase 3Active, not recruiting987 (actual)27 Jan 2020 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03043872 (opens in a new tab)

Posted results on ClinicalTrials.gov for CASPIAN

  • Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP (months)
    • Global Cohort: D + EP vs Global Cohort: EP: Hazard Ratio (HR) 0.73 (95% CI 0.591 to 0.909), p-value 0.0047, Log Rank, superiority
  • OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP (months)
    • Global Cohort: D + EP vs Global Cohort: EP: Hazard Ratio (HR) 0.75 (95% CI 0.625 to 0.910), p-value 0.0032, Log Rank, superiority
    • Global Cohort: D + T + EP vs Global Cohort: EP: Hazard Ratio (HR) 0.82 (95% CI 0.682 to 0.995), p-value 0.0451, Log Rank, superiority
  • OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP (months)
    • China Cohort: D + EP vs China Cohort: EP: Hazard Ratio (HR) 0.65 (95% CI 0.414 to 1.029), p-value 0.0664, Log Rank, other

Serious adverse events (All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO for each cohort; maximum of approximately 33 months for the Global cohort and maximum of approximately 29 months for the China cohort. Serious AEs and Deaths were collected through LTFU analysis in patients still receiving durvalumab (or within 90 days of discontinuing treatment); up to approximately 4 years.): Global Cohort: D + T + EP 126 of 266; Global Cohort: D + EP 86 of 265; Global Cohort: EP 97 of 266; China Cohort: D + T + EP 31 of 65; China Cohort: D + EP 26 of 61; China Cohort: EP 22 of 62

More posted outcomes or analyses are on the study page. All posted results for NCT03043872

Source: ClinicalTrials.gov results for NCT03043872 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing CASPIAN (4), newest first

  1. Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study.

    Future oncology (London, England) · 2025 May

  2. Molecular classification and biomarkers of outcome with immunotherapy in extensive-stage small-cell lung cancer: analyses of the CASPIAN phase 3 study.

    Molecular cancer · 2024 May 30

  3. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial.

    The Lancet. Oncology · 2021 Jan

  4. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial.

    Lancet (London, England) · 2019 Nov 23

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT02542293ClinicalTrials.gov record for NCT02542293 (opens in a new tab)NEPTUNEStudy of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)Phase 3Active, not recruiting953 (actual)21 Sep 2020 (actual) Yes First posted Results on ClinicalTrials.gov for NCT02542293 (opens in a new tab)

Posted results on ClinicalTrials.gov for NEPTUNE

  • Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set (months)
    • Global: Durvalumab + Tremelimumab vs Global: SoC Chemotherapy: Hazard Ratio (HR) 0.71 (95% CI 0.485 to 1.045), p-value 0.0808, Log Rank, superiority
  • OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set (months)
    • China: Durvalumab + Tremelimumab vs China: SoC Chemotherapy: Hazard Ratio (HR) 0.60 (95% CI 0.322 to 1.109), other

Serious adverse events (Assessed until final analysis DCO for each cohort (24 June 2019 for Global Cohort and 21 September 2020 for China Cohort); maximum timeframe of approximately 44 months for each cohort.): Global: Durvalumab + Tremelimumab 193 of 410; Global: SoC Chemotherapy 112 of 399; China: Durvalumab + Tremelimumab 32 of 77; China: SoC Chemotherapy 22 of 78

Source: ClinicalTrials.gov results for NCT02542293 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing NEPTUNE (1), newest first

  1. NEPTUNE China cohort: First-line durvalumab plus tremelimumab in Chinese patients with metastatic non-small-cell lung cancer.

    Lung cancer (Amsterdam, Netherlands) · 2023 Apr

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT02516241ClinicalTrials.gov record for NCT02516241 (opens in a new tab)Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial CancerPhase 3Active, not recruiting1,126 (actual)27 Jan 2020 (actual) Yes First posted Results on ClinicalTrials.gov for NCT02516241 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT02516241

  • To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set (Months)
    • Combination Therapy vs Standard of Care: Hazard Ratio (HR) 0.85 (98.66% CI 0.688 to 1.063), p-value 0.0751, Log Rank, superiority
  • To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set (Months)
    • Monotherapy vs Standard of Care: Hazard Ratio (HR) 0.89 (96.99% CI 0.695 to 1.139), p-value 0.3039, Log Rank, superiority

Serious adverse events (From first administration of study treatment up to 90 days after last dose of study medication or date of initiation of the first subsequent therapy, whichever occurs first, approximately 5 years. All-cause mortality, from screening up to data cut-off date (27JAN2020, approximately 5 years).): Combination Therapy 179 of 340; Monotherapy 139 of 345; Standard of Care 125 of 313

Source: ClinicalTrials.gov results for NCT02516241 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing NCT02516241 (1), newest first

  1. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial.

    The Lancet. Oncology · 2020 Dec

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT02551159ClinicalTrials.gov record for NCT02551159 (opens in a new tab)KESTRELPhase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck CancerPhase 3Completed823 (actual)6 Jul 2020 (actual) Yes First posted Results on ClinicalTrials.gov for NCT02551159 (opens in a new tab)

Posted results on ClinicalTrials.gov for KESTREL

  • Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) (Participants)
    • Durvalumab vs Standard of Care (SOC): Hazard Ratio (HR) 0.96 (95% CI 0.69 to 1.32), p-value 0.787, Log Rank, superiority

Serious adverse events (Adverse events and serious adverse events will be collected from the time of signature of informed consent throughout the treatment period and including the follow-up period (up to 90 days after the last dose of investigational product or until initiation of another therapy) for an average of approximately 4 years.): Durvalumab + Tremelimumab 168 of 408; Durvalumab 78 of 202; Standard of Care (SOC) 94 of 196

Source: ClinicalTrials.gov results for NCT02551159 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing KESTREL (2), newest first

  1. Outcomes in biomarker-selected subgroups from the KESTREL study of durvalumab and tremelimumab in recurrent or metastatic head and neck squamous cell carcinoma.

    Cancer immunology, immunotherapy : CII · 2024 Mar 2

  2. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era.

    The Lancet. Oncology · 2021 Apr

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT02369874ClinicalTrials.gov record for NCT02369874 (opens in a new tab)EAGLEStudy of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck CancerPhase 3Completed736 (actual)10 Sep 2018 (actual) Yes First posted Results on ClinicalTrials.gov for NCT02369874 (opens in a new tab)

Posted results on ClinicalTrials.gov for EAGLE

  • Overall Survival (OS) (Months)
    • Durvalumab + Tremelimumab vs Standard of Care (SoC): Hazard Ratio (HR) 1.04 (95% CI 0.85 to 1.26), p-value 0.7624, Log Rank, superiority
    • Durvalumab vs Standard of Care (SoC): Hazard Ratio (HR) 0.88 (95% CI 0.72 to 1.08), p-value 0.1993, Log Rank, superiority

Serious adverse events (First dose to last dose + 90 days or data cut off (maximum exposure 32 months)): Durvalumab + Tremelimumab 79 of 246; Durvalumab 69 of 237; Standard of Care (SoC) 61 of 240

Source: ClinicalTrials.gov results for NCT02369874 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing EAGLE (1), newest first

  1. Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2020 Jul

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT02453282ClinicalTrials.gov record for NCT02453282 (opens in a new tab)MYSTICPhase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)Phase 3Active, not recruiting1,118 (actual)4 Oct 2018 (actual) Yes First posted Results on ClinicalTrials.gov for NCT02453282 (opens in a new tab)

Posted results on ClinicalTrials.gov for MYSTIC

  • Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy (months)
    • Durvalumab Monotherapy vs SoC Chemotherapy: Hazard Ratio (HR) 0.76 (97.54% CI 0.564 to 1.019), p-value 0.036, Log Rank, superiority
    • Durvalumab + Tremelimumab vs SoC Chemotherapy: Hazard Ratio (HR) 0.85 (98.77% CI 0.611 to 1.173), p-value 0.202, Log Rank, superiority
  • Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy (months)
    • Durvalumab + Tremelimumab vs SoC Chemotherapy: Hazard Ratio (HR) 1.05 (99.5% CI 0.722 to 1.534), p-value 0.705, Log Rank, superiority

Serious adverse events (From first administration of study treatment up to 90 days after last dose of durvalumab and tremelimumab or 30 days after last dose of SoC or date of initiation of the first subsequent therapy, whichever occurs first, approximately 3 years. All-cause mortality, from screening up to data cut-off date (approximately 3 years 1 month).): Durvalumab Monotherapy 131 of 369; Durvalumab + Tremelimumab 178 of 371; SoC Chemotherapy 112 of 352

Source: ClinicalTrials.gov results for NCT02453282 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing MYSTIC (2), newest first

  1. Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC).

    Clinical lung cancer · 2021 Jul

  2. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial.

    JAMA oncology · 2020 May 1

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT02352948ClinicalTrials.gov record for NCT02352948 (opens in a new tab)ARCTICA Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung CancerPhase 3Completed597 (actual)9 Feb 2018 (actual) Yes First posted Results on ClinicalTrials.gov for NCT02352948 (opens in a new tab)

Posted results on ClinicalTrials.gov for ARCTIC

  • Overall Survival (OS) (months)
    • Sub-study A: Durvalumab vs Sub-study A: SoC: Hazard Ratio (HR) 0.63 (95% CI 0.42 to 0.93), other
    • Sub-study B: Durvalumab+Tremelimumab vs Sub-study B: SoC: Hazard Ratio (HR) 0.80 (95% CI 0.61 to 1.05), p-value 0.109, Log Rank, superiority
  • Progression-Free Survival (PFS) (months)
    • Sub-study A: Durvalumab vs Sub-study A: SoC: Hazard Ratio (HR) 0.71 (95% CI 0.49 to 1.04), other
    • Sub-study B: Durvalumab+Tremelimumab vs Sub-study B: SoC: Hazard Ratio (HR) 0.77 (95% CI 0.59 to 1.01), p-value 0.056, Log Rank, superiority

Serious adverse events (From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.): Sub-study A: Durvalumab 23 of 62; Sub-study A: SoC 16 of 63; Sub-study B: Durvalumab+Tremelimumab 65 of 173; Sub-study B: SoC 28 of 110; Sub-study B: Durvalumab 36 of 117; Sub-study B: Tremelimumab 23 of 60

Source: ClinicalTrials.gov results for NCT02352948 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing ARCTIC (2), newest first

  1. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects.

    Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022 Jan

  2. ARCTIC: durvalumab with or without tremelimumab as third-line or later treatment of metastatic non-small-cell lung cancer.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2020 May

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Tremelimumab, newest first
ApplicationActionDateOutcomeReviewSource
BLA761270Action letter for BLA761270 (opens in a new tab) Original 1 Type 9 - New indication submitted as distinct BLA, consolidatedApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761289Action letter for BLA761289 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

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EU status (EMA)

Authorised

Imjudo (EMEA/H/C/006016)

Authorised
Therapeutic area
Carcinoma, Hepatocellular;Carcinoma, Non-Small-Cell Lung
Marketing authorisation holder
AstraZeneca AB
Active substance (INN)
tremelimumab
ATC code
L01FX20
Latest EMA decision

Matched by active substance: EMA's INN or active substance equals this drug's name. EMA lists 1 other product with this substance, such as generics.

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

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Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.