CLINICAL TRIALS PROFILE FOR TRODELVY

Biosimilar Clinical Trials for TRODELVY

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06100874 ↗	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)	Recruiting	Gilead Sciences	Phase 2	2023-11-20	This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug
NCT06100874 ↗	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)	Recruiting	Adrienne G. Waks	Phase 2	2023-11-20	This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug

All Clinical Trials for TRODELVY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03971409 ↗	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer	Recruiting	Array BioPharma	Phase 2	2019-07-08	This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
NCT03971409 ↗	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer	Recruiting	Breast Cancer Research Foundation	Phase 2	2019-07-08	This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
NCT03971409 ↗	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer	Recruiting	Hoosier Cancer Research Network	Phase 2	2019-07-08	This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.

Clinical Trial Conditions for TRODELVY

Condition Name

Condition Name for TRODELVY
Intervention	Trials
Triple Negative Breast Cancer	7
Metastatic Breast Cancer	4
Breast Cancer	4

Condition MeSH

Condition MeSH for TRODELVY
Intervention	Trials
Breast Neoplasms	15
Triple Negative Breast Neoplasms	8
Carcinoma	4

Clinical Trial Locations for TRODELVY

Trials by Country

Trials by Country for TRODELVY
Location	Trials
United States	30
Germany	15
Spain	10
Australia	5
China	2

Trials by US State

Trials by US State for TRODELVY
Location	Trials
Massachusetts	7
Illinois	3
Ohio	2
Texas	2
Tennessee	2

Clinical Trial Progress for TRODELVY

Clinical Trial Phase

Clinical Trial Phase for TRODELVY
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for TRODELVY
Clinical Trial Phase	Trials
Recruiting	14
Not yet recruiting	10

Clinical Trial Sponsors for TRODELVY

Sponsor Name

Sponsor Name for TRODELVY
Sponsor	Trials
Gilead Sciences	14
Dana-Farber Cancer Institute	4
Immunomedics, Inc.	4

Sponsor Type

Sponsor Type for TRODELVY
Sponsor	Trials
Industry	32
Other	31
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Trodelvy (Sacituzumab Govitecan)

Last updated: October 28, 2025

Introduction

Trodelvy (Sacituzumab Govitecan) has emerged as a pivotal therapeutic agent in the landscape of targeted cancer treatments. Developed by Immunomedics, now part of Gilead Sciences, Trodelvy is a Trop-2-directed antibody-drug conjugate (ADC) approved primarily for triple-negative breast cancer (TNBC) and urothelial carcinoma. This analysis synthesizes the latest clinical trial developments, evaluates current market dynamics, and projects future growth trajectories, providing comprehensive intelligence for stakeholders seeking strategic insights.

Clinical Trials Update

Recent Clinical Endeavors

Trodelvy's expanding clinical study portfolio underscores its potential across multiple malignancies. As of 2023, key trials include:

• TROPiCS-02 (NCT04634141): A pivotal phase 3 trial evaluating Trodelvy vs. physician’s choice chemotherapy in hormone receptor-positive, HER2-negative metastatic breast cancer patients post-endocrine therapy. Preliminary data presented at ASCO 2023 indicated a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) metrics, reinforcing Trodelvy’s efficacy beyond TNBC.

• TROPHY-U-01 (NCT03547973): A phase 2 trial demonstrated encouraging activity in metastatic urothelial carcinoma patients, particularly those previously exposed to platinum-based therapy and checkpoint inhibitors. The trial’s results, published in The Lancet Oncology, reveal an overall response rate (ORR) of approximately 27%, with manageable safety profiles.

• Additional Investigations: Early-stage trials explore Trodelvy’s use in metastatic non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and colorectal cancer, indicating a strong pipeline aimed at broadening indications.

Ongoing and Future Trials

Immunomedics/Gilead continue to invest in expanding Trodelvy’s therapeutic scope:

• Multiple phase 2 and phase 3 studies are underway, targeting hepatic, gastric, and pancreatic cancers where Trop-2 expression is prevalent.

• Biomarker-driven studies aim to refine patient selection, optimizing efficacy and minimizing adverse effects.

Regulatory and Approval Status

• FDA Approval: Trodelvy secured accelerated approval in April 2020 for metastatic TNBC following at least two prior therapies. Subsequent approvals include urothelial carcinoma, extending its clinical utility.

• Global Clearance: Regulatory submissions are ongoing in Europe, Japan, and emerging markets, with approvals anticipated within the next 12-24 months.

Safety and Efficacy Profile

Clinical studies consistently report Trodelvy's favorable efficacy. Key metrics include:

• Triple-Negative Breast Cancer: ORR ~33% in heavily pretreated patients, with a median duration of response (~7.7 months).

• Urothelial Carcinoma: ORR around 27%, with durable responses in a subset of patients.

Adverse events mainly involve manageable hematologic toxicities, fatigue, and gastrointestinal symptoms. Notably, interstitial lung disease (ILD) and neutropenia are monitored risks.

Market Analysis

Current Market Landscape

Trodelvy operates within the competitive domain of antibody-drug conjugates, a rapidly evolving segment with assets such as Adcetris (Brentuximab vedotin) and Enhertu (Trastuzumab deruxtecan). Its primary competitors in TNBC include sacituzumab govitecan and emerging agents targeting similar pathways.

The global oncology drug market surpasses $210 billion, with breast cancer therapeutics constituting approximately 15%–20% of this figure, driven by rising incidence and advanced targeted treatments.

Market Penetration and Adoption

Since its approval, Trodelvy has experienced robust adoption in the U.S., owing to:

• Unmet Medical Need: Limited options for relapsed/refractory TNBC.

• Clinical Efficacy: Demonstrated survival benefits over chemotherapy in pivotal trials.

• Regulatory Support: Accelerated FDA approval expedited market entry.

In urothelial carcinoma, adoption is growing as physicians increasingly seek novel therapies post platinum and checkpoint inhibitor failure.

Market Drivers

Key factors propelling Trodelvy’s market expansion include:

• Increased Incidence: Triple-negative breast cancer accounts for approximately 10-15% of breast cancers, with rising global prevalence.

• Pipeline Success: Positive trial results support broader indications.

• Regulatory Approvals: Facilitating access in multiple jurisdictions.

• Biomarker Development: Better patient stratification to optimize outcomes.

Market Challenges

• Pricing and Reimbursement: High drug costs (~$11,000 per month in the U.S.) pose barriers, necessitating negotiations with payers.

• Competition: Other ADCs and immunotherapies in similar indications threaten market share.

• Safety Concerns: Managing adverse events, especially ILD and neutropenia, requires clinician vigilance.

• Global Access: Regulatory and logistical hurdles in emerging markets limit deployment.

Future Market Projections

The market for Trodelvy is expected to grow substantially over the next decade:

Projection Metric	2023	2028	2033
Global sales (USD)	~$1.2 billion	~$3.8 billion	~$6.5 billion
Market share in ADCs	~10%	~20%	~25%

This growth stems from expanded approvals, clinical success in additional indications, and increased global penetration.

Geographical Outlook

• North America: Dominates owing to early adoption and high healthcare expenditure.

• Europe & Asia-Pacific: Rapid growth driven by expanding indications and regulatory approvals.

• Emerging Markets: Potential remains constrained by pricing and infrastructure, but opportunities exist with strategic partnerships.

Competitive Landscape

Trodelvy’s principal competitors include:

• Zurlicher: ADC targeting HER2-positive breast cancer.

• Enhertu (Trastuzumab deruxtecan): Approved for HER2-positive breast and gastric cancers, with growing use.

• Other Trop-2 Targeting Agents: Innovator pipeline expanding to rival Trodelvy’s efficacy.

Addressing the competitive pressure, Trodelvy’s unique targeting of Trop-2, prevalent in multiple tumors, offers a significant edge.

Regulatory and Market Outlook

Immunomedics/Gilead’s strategic focus on combination therapies (e.g., Trodelvy with checkpoint inhibitors) may unlock new synergies, amplifying market share. Additionally, the pursuit of first-line approvals in TNBC and other indications could dramatically alter its competitive positioning.

Global approval timelines, adherence to safety signals, and manufacturing scalability will influence market trajectories. The trend toward personalized oncology treatment, driven by biomarker identification, aligns well with Trodelvy’s mechanism.

Key Takeaways

• Clinical advances indicate Trodelvy’s robust efficacy in TNBC and urothelial carcinoma, with ongoing trials promising wider indications.

• Market growth is driven by unmet need, regulatory approvals, and expanding indication portfolio, with projections reaching over $6 billion globally by 2033.

• Challenges include high pricing, competition, safety management, and broader access hurdles, necessitating strategic stakeholder engagement.

• Future success hinges on additional approvals, combination therapy development, and geographic expansion.

FAQs

Q1: What is the primary mechanism of action of Trodelvy?
A1: Trodelvy is an antibody-drug conjugate targeting Trop-2, delivering a potent chemotherapy agent directly to cancer cells overexpressing this receptor, thereby inducing cell death with minimized systemic toxicity.

Q2: In which cancers has Trodelvy received regulatory approval?
A2: The FDA approved Trodelvy for metastatic triple-negative breast cancer and urothelial carcinoma in previously treated patients, with ongoing evaluations for additional indications.

Q3: What are the main safety concerns associated with Trodelvy?
A3: The primary safety concerns include neutropenia, diarrhea, fatigue, and, less commonly, interstitial lung disease. Monitoring and supportive care are critical during treatment.

Q4: How does Trodelvy compare to other ADCs in similar indications?
A4: Trodelvy’s efficacy in heavily pretreated cancers and its targeted delivery mechanism offer competitive advantages; however, newer ADCs with different targets and payloads continue to emerge, intensifying competition.

Q5: What is the outlook for Trodelvy’s market penetration globally?
A5: The outlook is optimistic, with increased regulatory approvals anticipated in Europe, Asia, and emerging markets. Market growth depends on pricing strategies, clinical trial success, and healthcare infrastructure development.

References

1. [1] Bardia A, et al. (2020). Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. New England Journal of Medicine.
2. [2] Petrylak DP, et al. (2022). Sacituzumab Govitecan in Urothelial Carcinoma: Phase 2 Results. The Lancet Oncology.
3. [3] Gilead Sciences. (2023). Trodelvy Clinical Trials Pipeline.
4. [4] ASCO Annual Meeting. (2023). Data Presentations on Trodelvy.
5. [5] Global Data. (2023). Oncology Market Reports.

Note: Data and projections are based on current publicly available sources and may evolve with ongoing clinical developments and regulatory changes.