Sacituzumab tirumotecan

Phase 3Antibody–drug conjugate

Sacituzumab tirumotecan is one of 316 therapeutic programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

315

Competitors

Pipeline

Status by Indication[2][1]

Indication

Esophageal Squamous Cell CarcinomaRecruiting

Gastric AdenocarcinomaNot yet recruiting

Triple-Negative Breast CancerRecruiting

Non-Small Cell Lung CancerRecruiting

Colorectal CancerRecruiting

Ovarian CancerRecruiting

Bladder CancerRecruiting

Endometrial CancerRecruiting

Cervical CancerRecruiting

Non Muscle Invasive Bladder CancerRecruiting

Esophageal Squamous Cell CarcinomaPreclinical

Recruiting

Gastric AdenocarcinomaPhase 2

Not yet recruiting

Triple-Negative Breast CancerPhase 3

Recruiting

Non-Small Cell Lung CancerPhase 3

Recruiting

Colorectal CancerPreclinical

Recruiting

Ovarian CancerPhase 3

Recruiting

Bladder CancerPhase 3

Recruiting

Endometrial CancerPhase 3

Recruiting

Cervical CancerPhase 3

Recruiting

Non Muscle Invasive Bladder CancerPreclinical

Recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Sacituzumab tirumotecan

Merck & Co.

Phase 3

1 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

PORTRAZZA

Eli Lilly

Preclinical

8 4

Imjudo

AstraZeneca

Preclinical

5 5

Vizimpro

Pfizer

Preclinical

4 6

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 7

Remeron

OOrganon and Co

Preclinical

1 8

PD-1 Inhibitor

Johnson & Johnson

Preclinical

2 9

Treatment

GSK

Preclinical

1 10

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 2Not yet recruiting

Gastric Adenocarcinoma

NCT07689292

Phase 2Not yet recruiting

Metastatic Head and Neck Carcinoma

NCT07686588

Q1 2029

PreclinicalRecruiting

Non Muscle Invasive Bladder Cancer

NCT06637423

Q2 2029

PreclinicalRecruiting

Esophageal Squamous Cell Carcinoma

NCT05319730

Q4 2029

PreclinicalRecruiting

Colorectal Cancer

NCT06428409

Phase 2Not yet recruiting

Bladder Cancer

NCT07662863

Clinical

Trials by Indication[1]

Breast Neoplasms2 trials

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06966700·2,400 enrolled

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06312176·1,200 enrolled

Bladder Cancer2 trials

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07419295·590 enrolled

A Randomized, Open-label, Phase II Study Evaluating the Neurotoxicity and Efficacy of Sacituzumab Tirumotecan (Sac-TMT) Versus MMAE-based ADCs in Patients With Advanced Urothelial Carcinoma: The SPARE-UC-01 Trial

Not yet recruiting·FFudan University·Phase 2·NCT07662863·75 enrolled

Non-small Cell Lung Cancer (NSCLC)2 trials

A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06305754·520 enrolled

A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06170788·614 enrolled

Esophageal Squamous Cell Carcinoma2 trials

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06780111·298 enrolled

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT05319730·230 enrolled

Non-Small Cell Lung Cancer1 trial

A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06312137·780 enrolled

12 more indications

Cervical Cancer1 trial

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07216703·1,023 enrolled

Non Muscle Invasive Bladder Cancer1 trial

A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06637423·32 enrolled

Ovarian Cancer1 trial

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06824467·770 enrolled

Triple Negative Breast Neoplasms1 trial

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06841354·1,000 enrolled

Gastric Adenocarcinoma1 trial

Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With Fruquintinib as Second-Line Therapy for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07689292·45 enrolled

Metastatic Head and Neck Carcinoma1 trial

A Prospective, Single-Center, Open-Label Phase II Clinical Study of Sacituzumab Tirumotecan Combined With Immune Checkpoint Inhibitors for the Later-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting·BBiying Chen·Phase 2·NCT07686588·20 enrolled

Endometrial Cancer1 trial

A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06952504·1,123 enrolled

Gastroesophageal Adenocarcinoma1 trial

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06445972·210 enrolled

Ovarian Neoplasms1 trial

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07318558·900 enrolled

Colorectal Cancer1 trial

A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06428409·220 enrolled

Triple-Negative Breast Cancer1 trial

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06393374·1,530 enrolled

Lung Neoplasm Malignant1 trial

KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06788912·60 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Sacituzumab tirumotecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
Open Targets Platform — Drug–disease associations for Sacituzumab tirumotecan. EMBL-EBI & Wellcome Sanger Institute.
[3]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Antibody–drug conjugate
Highest Phase: Phase 3[1]
Company: Merck & Co.

Sacituzumab tirumotecan

Status by Indication[2][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q1 2029

Q2 2029

Q4 2029

Trials by Indication[1]

Breast Neoplasms2 trials

Bladder Cancer2 trials

Non-small Cell Lung Cancer (NSCLC)2 trials

Esophageal Squamous Cell Carcinoma2 trials

Non-Small Cell Lung Cancer1 trial

Cervical Cancer1 trial

Non Muscle Invasive Bladder Cancer1 trial

Ovarian Cancer1 trial

Triple Negative Breast Neoplasms1 trial

Gastric Adenocarcinoma1 trial

Metastatic Head and Neck Carcinoma1 trial

Endometrial Cancer1 trial

Gastroesophageal Adenocarcinoma1 trial

Ovarian Neoplasms1 trial

Colorectal Cancer1 trial

Triple-Negative Breast Cancer1 trial

Lung Neoplasm Malignant1 trial

References

Drug Info

Quick Facts

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