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MEDI4736

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.

ASTRAZENECA PLC AZN · Non-Small-Cell Lung Carcinoma NSCLC; Urothelial Cancer

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    2

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
Indications
Non-Small-Cell Lung Carcinoma NSCLC; Urothelial 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 Current stageFirst trial start 21 Jul 20152 linked trials
  5. Filed Not yet
  6. Approved Not yet

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 MEDI4736. Editors add each one with its source.

Filed application

No filed application is on record for MEDI4736. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for MEDI4736.

Clinical trials

Trials linked to MEDI4736
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
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

    PubMed 32971005 (opens in a new tab)DOI 10.1016/S1470-2045(20)30541-6 (opens in a new tab)

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

    PubMed 33775558 (opens in a new tab)DOI 10.1016/j.cllc.2021.02.010 (opens in a new tab)

  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

    PubMed 32271377 (opens in a new tab)DOI 10.1001/jamaoncol.2020.0237 (opens in a new tab)

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

No FDA approvals on record for this drug.

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EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as MEDI4736.

Source: European Medicines Agency (EMA), medicines data download.

Related news

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Sources

Record updated .

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