Tremelimumab
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
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- 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)
- Applications
- BLA 761270 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761270 (opens in a new tab)
- BLA 761289 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761289 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 13 Jan 201517 linked trials
- Filed Completed
- 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
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06921785ClinicalTrials.gov record for NCT06921785 (opens in a new tab)ARTEMIDE-HCC01 | Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma | Phase 3 | Recruiting | 1,220 (estimated) | 15 Mar 2030 (estimated) | No |
| NCT05883644ClinicalTrials.gov record for NCT05883644 (opens in a new tab)SIERRA | Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC) | Phase 3 | Active, not recruiting | 111 (actual) | 30 Mar 2026 (actual) | No |
Publications listing SIERRA (1), newest first
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)TREMENDOUS | Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCC | Phase 3 | Active, not recruiting | 214 (actual) | 30 Sep 2026 (estimated) | No |
| NCT05301842ClinicalTrials.gov record for NCT05301842 (opens in a new tab)EMERALD-3 | Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC | Phase 3 | Active, not recruiting | 760 (actual) | 23 Feb 2026 (actual) | No |
Publications listing EMERALD-3 (1), newest first
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)VOLGA | Treatment 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 Cisplatin | Phase 3 | Active, not recruiting | 712 (actual) | 2 Mar 2026 (actual) | No |
| NCT03682068ClinicalTrials.gov record for NCT03682068 (opens in a new tab)NILE | Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer | Phase 3 | Active, not recruiting | 1,246 (actual) | 1 Jun 2026 (actual) | No |
Publications listing NILE (1), newest first
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)ADRIATIC | Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy | Phase 3 | Active, not recruiting | 730 (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
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
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)HIMALAYA | Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma | Phase 3 | Active, not recruiting | 1,324 (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
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
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)STRONG | An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies. | Phase 3 | Completed | 867 (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
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)POSEIDON | Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). | Phase 3 | Active, not recruiting | 1,186 (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
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
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)CASPIAN | Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) | Phase 3 | Active, not recruiting | 987 (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
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
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)NEPTUNE | Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE) | Phase 3 | Active, not recruiting | 953 (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
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
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 Cancer | Phase 3 | Active, not recruiting | 1,126 (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
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
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)KESTREL | Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer | Phase 3 | Completed | 823 (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
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
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)EAGLE | Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer | Phase 3 | Completed | 736 (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
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
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)MYSTIC | Phase 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 3 | Active, not recruiting | 1,118 (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
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
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)ARCTIC | A 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 Cancer | Phase 3 | Completed | 597 (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
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
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-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA761270Action letter for BLA761270 (opens in a new tab) | Original 1 Type 9 - New indication submitted as distinct BLA, consolidated | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| BLA761289Action letter for BLA761289 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
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Orange Book patents load here.
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Community discussion loads here.
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.
EMA page for Imjudo (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761289 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- Drugs@FDA 761270 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06921785 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05883644 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05557838 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05301842 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04960709 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03682068 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03703297 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03298451 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03084471 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03164616 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03043872 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02542293 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02516241 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02551159 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02369874 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02453282 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02352948 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761270 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA BLA761289 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.