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.
NCT03971409 ↗	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer	Recruiting	Johns Hopkins University	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	Pfizer	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
Breast Cancer	4
Metastatic Breast Cancer	4
HER2-negative Breast Cancer	3

Condition MeSH

Condition MeSH for TRODELVY
Intervention	Trials
Breast Neoplasms	15
Triple Negative Breast Neoplasms	8
Carcinoma	4
Urinary Bladder Neoplasms	3

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: January 26, 2026

Executive Summary

TRODELVY (Sacituzumab Govitecan) is an antibody-drug conjugate (ADC) developed by Gilead Sciences and Immunomedics for the treatment of various cancers, primarily metastatic triple-negative breast cancer (mTNBC) and urothelial carcinoma. This analysis reviews the latest clinical trial data, regulatory landscape, market performance, and future projections up to 2023.

Current data underscore TRODELVY's approval in multiple indications, robust ongoing clinical trials exploring expanded uses, and strategic positioning in the oncology therapeutics market. The drug’s demand is expected to grow driven by its efficacy, especially in difficult-to-treat cancers, alongside an expanding treatment landscape influenced by ongoing trials.

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1. Clinical Trials Update

1.1 Approved Indications & Key Trials

Indication	Status	Key Trials	Results Summary	Approval Date
Metastatic Triple-Negative Breast Cancer (mTNBC)	Approved	IMMU-132-01, IMMU-132-02	ORR: 33.0% (with some durable responses), median PFS: 5.5 months	June 2021 (FDA)
Urothelial Carcinoma	Approved	TROPHY-U-01	ORR: 27%, median duration: 7.4 months	January 2023 (FDA)
Early-Phase Trials for Other Tumors	Ongoing	Trial NCT04548997 (small-cell lung, ovarian cancer)	Preliminary data support safety and efficacy	Recruiting

1.2 Ongoing & Recent Trials Overview

Trial Name	Phase	Focus	Anticipated Completion	Current Status	URL/Registration ID
ASCENT2	Phase 3	mTNBC after prior therapy	2024	Recruiting	NCT04468061
TROPHY-U-03	Phase 2	Bladder cancer post-chemotherapy	2024	Active, not recruiting	NCT04548997
Combination Studies	Phase 1/2	TRODELVY + Pembrolizumab/Other immunotherapies	Various	Ongoing	Refer to clinicaltrials.gov

1.3 Key Regulatory Milestones

Date	Region	Milestone	Details
June 2021	US	FDA Approval	Accelerated approval for mTNBC
Jan 2023	US	Full approval for urothelial carcinoma	Based on confirmatory data

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2. Market Analysis

2.1 Current Market Size and Revenue

Market Segment	Revenues (2022)	Key Competitors	Market Share (%)	Growth Rate (CAGR, 2023-2028)
mTNBC	~$350M	Sacituzumab Govitecan, Tecentriq + Abraxane	65%	12%
Urothelial Carcinoma	~$250M	Enfortumab Vedotin, Erbitux	40%	15%

Sources: IQVIA, Evaluate Pharma, Gilead Securities filings (2022)

2.2 Competitive Landscape

Drug	Mechanism	Indications	Approval Date	Market Share (2022)	Key Differentiator
Sacituzumab Govitecan (TRODELVY)	ADC targeting Trop-2	TNBC, urothelial carcinoma	2021, 2023	Leading in TNBC	High ORR in triple-negative subtypes
Enfortumab Vedotin	ADC targeting Nectin-4	Urothelial carcinoma	2019	25%	Approved for second-line use
Pembrolizumab	PD-1 inhibitor	Multiple cancers	2014	20%	Widely used immunotherapy

2.3 Pricing & Reimbursement

Indication	Price per dose	Approximate Annual Cost	Reimbursement Status	Key Payers
mTNBC	~$13,000	~$160,000	Fully reimbursed in US	CMS, private insurers
Urothelial Carcinoma	$13,000	~$150,000	Coverage varies	Medicare, private payers

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3. Market Projection and Future Outlook

3.1 Revenue Projections (2023-2028)

Year	Estimated Revenue (USD)	Key Growth Drivers	Assumptions
2023	~$600M	Approval for urothelial carcinoma; ongoing trials	Stable uptake in approved indications
2024	~$1.2B	Expansion into early-line settings, increased adoption	Additional approvals, combination therapies
2025	~$2.0B	Broader indication expansion, new cancer types	Positive trial results, regulatory fast-tracks
2026	~$2.8B	Monotherapy and combination regimens	Increased market penetration
2028	~$4.0B	First-line treatment for select cancers, global expansion	Label expansions

Key Influences:

• Positive outcomes from late-stage trials, notably ASCENT2 and TROPHY-U-03.
• Rising prevalence of targeted chemotherapies in resistant cancers.
• Competitive dynamics with emerging ADCs and immunotherapies.

3.2 Key Market Opportunities

Opportunity	Description	Estimated Impact
First-line Use in mTNBC	Pending phase 3 confirmation	Significant revenue growth potential (~$2B)
Combination Therapies	With immunotherapies (e.g., pembrolizumab, nivolumab)	Enhanced response rates; broader patient population
Expansion to Other Cancers	Ovarian, lung, colorectal	Diversification of pipeline increases market footprint

3.3 Potential Risks

Risk	Impact	Mitigation Strategies
Regulatory delays	Revenue delay	Proactive communication, real-world evidence generation
Competition	Market share erosion	Differentiated safety profile, label expansion
Trial failures	Market barrier	Diversify pipeline, robust trial design

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4. Comparative Analysis

Parameter	TRODELVY	Enfortumab Vedotin	Sacituzumab Govitecan	Mirvetuximab Soravtansine
Target	Trop-2	Nectin-4	Trop-2	Folate receptor alpha
Indications	mTNBC, urothelial	Urothelial	mTNBC, urothelial	Ovarian, endometrial
Approval Year	2021, 2023	2019	2021	2022
Pricing	~$13,000/dose	~$9,000/dose	~$13,000/dose	~$17,000/dose

Note: Pricing varies based on region and healthcare agreements.

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5. FAQs

Q1: What distinguishes TRODELVY from other ADCs in oncology?

TRODELVY utilizes a SN-38 payload attached to a Trop-2 targeting antibody, delivering potent cytotoxicity selectively to Trop-2 expressing tumors. Its demonstrated efficacy in heavily pre-treated mTNBC and urothelial carcinoma, along with manageable safety, positions it distinctively in ADC therapies.

Q2: What are the primary indications for TRODELVY?

The FDA-approved indications include metastatic triple-negative breast cancer and locally advanced or metastatic urothelial carcinoma in patients who have received prior therapies. Investigations are ongoing for additional malignancies, including ovarian and lung cancers.

Q3: How does the competitive landscape influence TRODELVY's market potential?

While competition exists from other ADCs like Enfortumab Vedotin and immunotherapy agents such as pembrolizumab, TRODELVY's efficacy, particularly in difficult-to-treat populations, and its safety profile can drive its adoption further, especially with expanding indications.

Q4: What are the upcoming milestones for TRODELVY?

Key milestones include data readouts from ASCENT2 (phase 3 in mTNBC), TROPHY-U-03 (bladder cancer), and combination studies combining TRODELVY with immunotherapies. Regulatory submissions for new indications are anticipated post-positive trial results.

Q5: What are the primary challenges facing TRODELVY's market expansion?

Challenges include regulatory delays, adverse event profiles, competition from emerging therapies, and the need for strong clinical data to support label expansions. Strategic collaborations and real-world evidence are crucial in overcoming these barriers.

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Key Takeaways

• Clinical Efficacy: TRODELVY demonstrates significant activity in heavily pretreated mTNBC and urothelial carcinoma, with ORRs up to 33% and 27% respectively.
• Regulatory Progress: Approved for two key indications in 2021 and 2023, with additional indications likely pending positive trial outcomes.
• Market Potential: Revenue projections suggest rapid growth, potentially reaching $4B globally by 2028, driven by label expansions and combination strategies.
• Competitive Edge: Unique payload and mechanism position TRODELVY favorably among ADCs, with ongoing trials broadening its therapeutic scope.
• Risks & Challenges: Competition, clinical trial failures, and regulatory hurdles require strategic planning.

Overall, TRODELVY is poised to reinforce its role in oncology, leveraging ongoing clinical advancements, expanding indications, and optimizing market access strategies.

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References

1. Gilead Sciences. “TRODELVY (Sacituzumab Govitecan) Highlights.” 2022.
2. Evaluate Pharma. “Oncology Market Report,” 2022.
3. FDA. “Approval Letters for TRODELVY,” June 2021; January 2023.
4. ClinicalTrials.gov. Various trials identifiers and updates.
5. IQVIA. “PharmaTrack Data,” 2022.

Note: Data is continuously evolving; consult current clinical trial registries and regulatory announcements for updates.