CLINICAL TRIALS PROFILE FOR OGIVRI

Biosimilar Clinical Trials for OGIVRI

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04266249 ↗	CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy	Recruiting	National Cancer Institute (NCI)	Phase 2	2020-02-11	This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
NCT04266249 ↗	CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy	Recruiting	ECOG-ACRIN Cancer Research Group	Phase 2	2020-02-11	This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

All Clinical Trials for OGIVRI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Canadian Cancer Trials Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Cancer and Leukemia Group B	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Southwest Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

Clinical Trial Conditions for OGIVRI

Condition Name

Condition Name for OGIVRI
Intervention	Trials
Stage IIIA Breast Cancer AJCC v7	8
Stage IIIC Breast Cancer AJCC v7	7
Stage IV Breast Cancer AJCC v6 and v7	6
Stage IIIB Breast Cancer AJCC v7	6

Condition MeSH

Condition MeSH for OGIVRI
Intervention	Trials
Breast Neoplasms	18
Carcinoma	13
Adenocarcinoma	5
Esophageal Neoplasms	2

Clinical Trial Locations for OGIVRI

Trials by Country

Trials by Country for OGIVRI
Location	Trials
United States	437
Canada	14
Ireland	7
Puerto Rico	5
South Africa	1

Trials by US State

Trials by US State for OGIVRI
Location	Trials
Texas	14
Washington	12
North Carolina	11
California	11
New York	10

Clinical Trial Progress for OGIVRI

Clinical Trial Phase

Clinical Trial Phase for OGIVRI
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	8
Phase 1/Phase 2	5

Clinical Trial Status

Clinical Trial Status for OGIVRI
Clinical Trial Phase	Trials
Recruiting	11
Active, not recruiting	6
Completed	3

Clinical Trial Sponsors for OGIVRI

Sponsor Name

Sponsor Name for OGIVRI
Sponsor	Trials
National Cancer Institute (NCI)	21
NRG Oncology	5
University of Washington	2

Sponsor Type

Sponsor Type for OGIVRI
Sponsor	Trials
Other	24
NIH	21
Industry	7

OGIVRI Market Analysis and Financial Projection

Last updated: May 6, 2026

OGIVRI (Trastuzumab-dkst) Clinical Trials Update, Market Analysis and Projections

What is OGIVRI and where does it sit in the clinical pipeline?

OGIVRI is a biosimilar to trastuzumab (Herceptin) and targets HER2-positive cancers. It is already commercially established across major HER2 indications, so “clinical trials update” for OGIVRI is dominated by biosimilar comparability studies already completed and post-approval pharmacovigilance rather than a separate active late-stage development program.

Current development posture (what drives “trials update” in practice):

• No clear ongoing Phase 3 “OGIVRI-only” registration trials are visible from public registries at the same level of disclosure as originator programs.
• Regulatory and clinical evidence is primarily comparability-based (PK/PD, immunogenicity, and efficacy bridging) rather than new oncology endpoints designed around a novel mechanism.
• The practical clinical evidence flow for biosimilars is interchangeability uptake, real-world safety monitoring, and label maintenance.

Key implication for planning and forecasting: market trajectory for OGIVRI is shaped mainly by pricing, payer contracting, interchange policy, tender behavior, and Herceptin competitive dynamics, not by new clinical efficacy readouts.

Which trial and evidence types matter for OGIVRI going forward?

For biosimilars, the ongoing “clinical evidence” stream tends to be:

• Post-marketing safety surveillance (including immunogenicity and infusion-related reactions) aligned to label use.
• Real-world evidence studies evaluating persistence, switching, and discontinuation reasons across HER2 lines of therapy.
• Naming and interchange frameworks: switches occur at the pharmacy or provider level; clinical outcomes then reflect how the biosimilar is used in routine care.

Because OGIVRI’s clinical utility is label-driven, the most actionable items for a forecast are not new endpoints but uptake constraints and reimbursement economics.

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How is OGIVRI used in oncology markets and what are its core label drivers?

OGIVRI is used in HER2-positive breast and other HER2-driven cancers (per trastuzumab labeling). Demand is driven by:

• incidence and treatment prevalence of HER2-positive breast cancer
• use in early-stage and metastatic settings
• line of therapy penetration for HER2-targeted biologics
• payer preference policies (least cost substitution, step therapy, and formulary placement)
• biosimilar-to-originator competitive pricing

Market takeaway: OGIVRI’s peak opportunity comes when payers treat trastuzumab biosimilars as interchangeable economic alternatives at scale, particularly in US and EU markets.

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What is the competitive landscape for trastuzumab biosimilars and how does it affect OGIVRI?

OGIVRI competes against other trastuzumab biosimilars and the originator (Herceptin). Forecasting depends on:

• number of biosimilars on formulary
• tender and contracting structure (single-source vs multi-source)
• pipeline timing for further biosimilar entrants
• originator price and patient access strategy

Competition dynamics that typically accelerate biosimilar uptake:

• expanding formulary coverage for biosimilars
• increased biosimilar prescribing comfort due to safety experience
• payer policies favoring the lowest net-cost option after rebates

Net effect for OGIVRI: market share is more sensitive to contracting and rebates than to incremental clinical endpoints.

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Clinical trial update: what does the publicly visible evidence concentration look like?

Public oncology registries and regulatory packages for biosimilars usually show:

• a comparability “bridging” pattern rather than novel efficacy trials
• immunogenicity monitoring and PK similarity as primary scientific comparisons

For OGIVRI, the clinical strategy follows the biosimilar template: establish equivalence, then scale through prescribing and payer decisions.

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OGIVRI market analysis (where revenue comes from)

OGIVRI’s addressable market is the trastuzumab-treated HER2-positive population. The forecast framework should segment demand by:

• setting (adjuvant/early-stage vs metastatic)
• care setting mix (hospital outpatient infusion vs specialty clinics)
• payer environment (commercial, Medicare, Medicaid, and institutional tender mechanisms)
• treatment line and duration patterns (infusion schedules with variable length based on regimen)

Drivers of OGIVRI volume:

• biosimilar substitution rate (prescription switching)
• net price versus competing biosimilars and originator
• tender frequency and procurement scale discounts
• supply continuity (biosimilars are sensitive to lot-level disruption)

Drivers of OGIVRI pricing:

• tender-based pricing in bulk procurement markets
• US ASP and rebate-driven net pricing
• EU country pricing regulations and tender outcomes
• competitive price erosion as more biosimilars enter

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OGIVRI projections: scenario structure that fits biosimilar realities

A robust projection for OGIVRI should be built on:

1. Uptake curve (share shift from originator to biosimilars)
2. Competitive price pressure (net price decreases with share and with additional entrants)
3. Stability of treated population (incidence and treatment prevalence trend)
4. Regimen mix (substitution affects number of administered cycles, not just unit count)

Core projection logic (without introducing fabricated numeric assumptions):

• If payer formulary coverage expands and contracting favors OGIVRI, share increases via pharmacy and provider switching.
• If competing biosimilars secure better contracting, OGIVRI’s share growth slows even if the biosimilar category grows overall.
• Net revenue depends on both volume share and net pricing under rebate and tender mechanisms.

This is the standard biosimilar projection approach for an established HER2 franchise: market expansion comes from substitution and pricing, not new trial breakthroughs.

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Commercial signals to track (high-value KPIs for OGIVRI)

These are the indicators that typically move OGIVRI revenue most:

• Formulary and coverage expansion in large payer systems and IDNs
• Tender outcomes and national/provincial procurement awards
• Net price movement relative to other trastuzumab biosimilars
• Switch rates reported in real-world datasets
• Safety and immunogenicity findings in post-marketing surveillance (affects prescriber confidence)

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Key Takeaways

• OGIVRI’s “clinical trials update” is mostly a biosimilar compliance and post-marketing monitoring story rather than a new late-stage clinical engine.
• Market growth is driven primarily by biosimilar uptake, payer contracting, and net pricing versus Herceptin and other trastuzumab biosimilars.
• A practical projection model must anchor on share shift and tender pricing with the HER2-treated population providing the baseline demand.

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FAQs

1) Is OGIVRI currently driven by new Phase 3 oncology outcomes?
OGIVRI is primarily driven by biosimilar comparability evidence and label use rather than new Phase 3 “OGIVRI-only” efficacy endpoints.

2) What determines OGIVRI revenue more: market incidence or substitution behavior?
Substitution behavior and net contracting terms usually dominate because the addressable treated population is relatively stable while biosimilar share and price shift.

3) How do tenders and rebates typically impact OGIVRI?
They set the net price and can rapidly move share among competing trastuzumab biosimilars based on procurement awards.

4) What does “post-marketing” monitoring contribute to OGIVRI forecasts?
It influences prescriber confidence and continued access, which affects persistence and switching rather than changing clinical efficacy on-label.

5) What should investors and R&D leaders track for OGIVRI momentum?
Formulary status, tender award patterns, net price movement versus competitors, and real-world switching and persistence trends.

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References

[1] EMA. European public assessment reports for trastuzumab biosimilars and related regulatory reviews. European Medicines Agency.
[2] FDA. Prescribing information and regulatory review documents for OGIVRI (trastuzumab-dkst). U.S. Food and Drug Administration.
[3] ClinicalTrials.gov. OGIVRI (trastuzumab-dkst) search results and study listings. U.S. National Library of Medicine.
[4] FDA. Biosimilar biologics approval pathway and interchange-related frameworks. U.S. Food and Drug Administration.