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Sacituzumab tirumotecan

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.

Merck & Co., Inc. MRK · Non-small Cell Lung Cancer (NSCLC); Breast Neoplasms; Cervical Cancer; Endometrial Cancer; Ovarian 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

    16

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Merck & Co., Inc. MRK Source: Company record for Merck & Co., Inc. (opens in a new tab)
Indications
Non-small Cell Lung Cancer (NSCLC); Breast Neoplasms; Cervical Cancer; Endometrial Cancer; Ovarian 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 12 Nov 202316 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 Sacituzumab tirumotecan. Editors add each one with its source.

Filed application

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

FDA advisory committees

No FDA advisory committee meetings are on record for Sacituzumab tirumotecan.

Clinical trials

Trials linked to Sacituzumab tirumotecan
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT07419295ClinicalTrials.gov record for NCT07419295 (opens in a new tab)TroFuse-031A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)Phase 3Recruiting590 (estimated)27 Jul 2029 (estimated) No
NCT07318558ClinicalTrials.gov record for NCT07318558 (opens in a new tab)TroFuse-021A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)Phase 3Recruiting900 (estimated)25 Feb 2033 (estimated) No
NCT07216703ClinicalTrials.gov record for NCT07216703 (opens in a new tab)A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)Phase 3Recruiting1,023 (estimated)29 Oct 2031 (estimated) No
NCT06966700ClinicalTrials.gov record for NCT06966700 (opens in a new tab)A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)Phase 3Recruiting2,400 (estimated)23 Mar 2033 (estimated) No

Publications listing NCT06966700 (1), newest first

  1. TroFuse-032 study design: pembrolizumab plus sacituzumab tirumotecan or chemotherapy followed by pembrolizumab plus chemotherapy as neoadjuvant therapy for early-stage, triple-negative breast cancer or HR-low+/HER2- breast cancer.

    Future oncology (London, England) · 2026 Oct 14

    PubMed 42872715 (opens in a new tab)DOI 10.1080/14796694.2026.2732590 (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.

NCT06952504ClinicalTrials.gov record for NCT06952504 (opens in a new tab)TroFuse-033A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)Phase 3Recruiting1,123 (estimated)24 May 2032 (estimated) No
NCT06824467ClinicalTrials.gov record for NCT06824467 (opens in a new tab)A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)Phase 3Recruiting770 (estimated)27 Apr 2029 (estimated) No
NCT06841354ClinicalTrials.gov record for NCT06841354 (opens in a new tab)A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)Phase 3Recruiting1,000 (estimated)18 May 2030 (estimated) No

Publications listing NCT06841354 (1), newest first

  1. TroFuse-011 study design: sacituzumab tirumotecan with or without pembrolizumab for advanced triple-negative breast cancer with PD-L1 CPS <10.

    Future oncology (London, England) · 2026 Aug

    PubMed 42535874 (opens in a new tab)DOI 10.1080/14796694.2026.2701483 (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.

NCT06459180ClinicalTrials.gov record for NCT06459180 (opens in a new tab)A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)Phase 3Active, not recruiting686 (estimated)15 Jun 2028 (estimated) No
NCT06393374ClinicalTrials.gov record for NCT06393374 (opens in a new tab)Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)Phase 3Recruiting1,530 (estimated)16 Dec 2030 (estimated) No
NCT06305754ClinicalTrials.gov record for NCT06305754 (opens in a new tab)Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)Phase 3Active, not recruiting550 (estimated)17 Aug 2028 (estimated) No
NCT06356311ClinicalTrials.gov record for NCT06356311 (opens in a new tab)TroFuse-015A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)Phase 3Active, not recruiting473 (actual)19 Oct 2026 (actual) No
NCT06312176ClinicalTrials.gov record for NCT06312176 (opens in a new tab)A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)Phase 3Recruiting1,200 (estimated)11 Jul 2027 (estimated) No
NCT06312137ClinicalTrials.gov record for NCT06312137 (opens in a new tab)TroFuse-019A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)Phase 3Recruiting780 (estimated)21 Feb 2034 (estimated) No
NCT06170788ClinicalTrials.gov record for NCT06170788 (opens in a new tab)TroFuse-007Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)Phase 3Recruiting614 (estimated)25 Jan 2028 (estimated) No
NCT06132958ClinicalTrials.gov record for NCT06132958 (opens in a new tab)TroFuse-005Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)Phase 3Active, not recruiting710 (estimated)10 Jan 2028 (estimated) No
NCT06074588ClinicalTrials.gov record for NCT06074588 (opens in a new tab)Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)Phase 3Active, not recruiting556 (estimated)10 May 2027 (estimated) No

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 Sacituzumab tirumotecan.

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

Related news

Sources

Record updated .

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