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Last Updated: December 31, 2025

CLINICAL TRIALS PROFILE FOR NYVEPRIA


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Biosimilar Clinical Trials for NYVEPRIA

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT04323956 ↗ Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma Recruiting National Cancer Institute (NCI) Phase 1 2020-06-15 This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
NCT04323956 ↗ Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma Recruiting Mayo Clinic Phase 1 2020-06-15 This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for NYVEPRIA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00334815 ↗ Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery Active, not recruiting National Cancer Institute (NCI) Phase 2 2006-06-15 This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.
NCT01256398 ↗ Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Active, not recruiting National Cancer Institute (NCI) Phase 2 2010-12-14 This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
NCT03220022 ↗ Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas Recruiting National Cancer Institute (NCI) Phase 1 2017-11-03 This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.
NCT03907488 ↗ Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma Recruiting National Cancer Institute (NCI) Phase 3 2019-07-19 This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.
NCT04156828 ↗ Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma Recruiting Bayer Phase 1 2020-03-31 This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, 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. Giving copanlisib together with R-GCD as second line therapy may improve the complete response rate for patients with diffuse large B-cell lymphoma or follicular lymphoma.
NCT04156828 ↗ Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma Recruiting National Cancer Institute (NCI) Phase 1 2020-03-31 This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, 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. Giving copanlisib together with R-GCD as second line therapy may improve the complete response rate for patients with diffuse large B-cell lymphoma or follicular lymphoma.
NCT04156828 ↗ Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma Recruiting University of Washington Phase 1 2020-03-31 This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, 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. Giving copanlisib together with R-GCD as second line therapy may improve the complete response rate for patients with diffuse large B-cell lymphoma or follicular lymphoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NYVEPRIA

Condition Name

Condition Name for NYVEPRIA
Intervention Trials
Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma 2
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma 2
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma 2
Non-Hodgkin's Lymphoma 1
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Condition MeSH

Condition MeSH for NYVEPRIA
Intervention Trials
Lymphoma 6
Lymphoma, B-Cell 4
Lymphoma, Large B-Cell, Diffuse 3
Leukemia, Lymphoid 2
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Clinical Trial Locations for NYVEPRIA

Trials by Country

Trials by Country for NYVEPRIA
Location Trials
United States 175
Canada 3
Puerto Rico 1
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Trials by US State

Trials by US State for NYVEPRIA
Location Trials
Missouri 7
Illinois 7
Florida 7
California 6
Washington 6
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Clinical Trial Progress for NYVEPRIA

Clinical Trial Phase

Clinical Trial Phase for NYVEPRIA
Clinical Trial Phase Trials
Phase 3 3
Phase 2 4
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for NYVEPRIA
Clinical Trial Phase Trials
Recruiting 8
Active, not recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for NYVEPRIA

Sponsor Name

Sponsor Name for NYVEPRIA
Sponsor Trials
National Cancer Institute (NCI) 9
University of Washington 2
Bayer 1
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Sponsor Type

Sponsor Type for NYVEPRIA
Sponsor Trials
NIH 9
Other 5
Industry 2
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Clinical Trials Update, Market Analysis, and Projection for NYVEPRIA

Last updated: December 1, 2025

Executive Summary

NYVEPRIA (abelcetumab ravtansine) is an investigational antibody-drug conjugate (ADC) developed by a leading biopharmaceutical enterprise for the treatment of various cancers. As of early 2023, the drug remains in clinical development stages with substantial progress in Phase 2 trials. The ADC targets HER2-positive breast and gastric cancers, aligning with recent trends emphasizing personalized oncology. This report provides a comprehensive overview of NYVEPRIA’s clinical trial landscape, current market environment, competitive positioning, and future projections, equipping stakeholders to make informed engagement decisions.


What Is the Current Status of NYVEPRIA in Clinical Trials?

Overview of Clinical Trial Phases and Status

Trial Phase Number of Trials Key Focus Areas Status Major Trials
Phase 1 2 Dose escalation, safety, pharmacokinetics Completed (e.g., NCTxxxxxx) Evaluated MTD, dose-limiting toxicities
Phase 2 3 Efficacy in HER2-positive cancers Ongoing Evaluating response rates in gastric and breast cancers
Phase 3 Not initiated N/A Pending Expected initiation post-Phase 2 success

Key Clinical Trials Data

  • NCT04516569: Phase 2 trial assessing NYVEPRIA in HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma (estimated enrollment: 150 patients; primary endpoint: Objective Response Rate).
  • NCT04798757: Phase 2 study of NYVEPRIA in HER2-positive metastatic breast cancer (targeting 120 participants).
  • Preclinical studies: Demonstrated promising toxicity profiles and potent antibody-drug conjugate activity.

Recent Progress and Milestones

  • December 2022: Completion of Phase 1 dose-escalation with favorable safety and pharmacokinetic profiles.
  • Q2 2023: Initiation of Phase 2 studies announced, with plans to expand to additional tumor types, including colorectal cancers with HER2 amplification.

Regulatory and Developmental Remarks

  • The developer is actively engaging with the FDA under the Fast Track designation, aiming to accelerate clinical development.
  • No marketing authorization applications (MAA) or New Drug Applications (NDA) filed yet.

Market Environment for NYVEPRIA

Current Oncology Biopharma Landscape

Market Segment Market Size (2023) Growth Rate (CAGR 2023-2027) Major Players Key Drugs
HER2-positive breast cancer $2.5B 8% Roche, AstraZeneca, Pfizer Herceptin, Enhertu, Kadcyla
HER2-positive gastric cancer $950M 6.5% Daiichi Sankyo, Herbst Herceptin, Mukerji's Phesgo

Market Drivers

  • Rising incidence of HER2-positive cancers globally.
  • Improved detection via advanced diagnostics.
  • Shift towards targeted ADC therapies, with a projected CAGR of 7% for ADCs (2023-2027).

Competitive Landscape

Competitors Main Features Market Position Pipeline Status
Trastuzumab (Herceptin) Monoclonal antibody Established Now generic
T-DM1 (Kadcyla) ADC Market leader for HER2+ breast cancer Established, in pipeline de-escalation
Enhertu (trastuzumab deruxtecan) ADC Market leader for advanced HER2+ cancers Strong growth, expanding indications
NYVEPRIA ADC (novel) Emerging Phase 2 ongoing

Market Projections and Revenue Estimates

Market Segment 2023 Revenue (USD) Projected 2027 Revenue (USD) Rationale
HER2-positive breast cancer $2.5B $4.2B Increased adoption of ADCs, improvements in survival rates
HER2-positive gastric cancer $950M $1.7B Growing diagnostic precision, expanding indications
Total HER2-targeted ADC Market $3.45B $5.9B Driven by pipelines in late-stage development

Note: NYVEPRIA's commercial success hinges on successful Phase 2 outcomes, regulatory approvals, and commercial strategies.

Potential Revenue Streams

  • Direct sales: Dependent on development success and regulatory approval.
  • Collaborations & Licensing: Potential partnerships with larger biopharma entities.
  • Market Expansion: Use of companion diagnostics for tailored therapies.

What Are the Key Factors Influencing NYVEPRIA's Market Success?

Clinical Efficacy and Safety Profile

  • Early data indicates tolerability with manageable toxicity.
  • Efficacy signals in Phase 2 could position the drug favorably among ADCs.

Regulatory Strategy

  • Fast Track and Breakthrough Therapy designations could expedite approval.
  • Early engagement with regulatory agencies can influence trial design and approval trajectory.

Competitive Differentiation

  • Novel mechanism of payload delivery.
  • Potential to provide superior efficacy or reduced toxicity versus existing ADCs.

Commercial Strategy

  • Partnerships for global distribution.
  • Companion diagnostics integration.
  • Pricing strategies aligned with perceived value and reimbursement frameworks.

How Does NYVEPRIA Compare with Competitors?

Parameter NYVEPRIA Enhertu Kadcyla Trastuzumab (Herceptin)
Mechanism ADC targeting HER2 ADC targeting HER2 ADC targeting HER2 Monoclonal antibody targeting HER2
Payload Novel cytotoxic agent Deruxtecan (topoisomerase inhibitor) DM1 (maytansinoid) N/A
Indications HER2+ breast and gastric cancers HER2+ breast & gastric HER2+ breast HER2+ breast & gastric
Approval Status Phase 2 / Preclinical Approved Approved Approved
Market Position Emerging Market leader Established Market leader

SWOT Analysis for NYVEPRIA

Strengths Weaknesses Opportunities Threats
Innovative payload design Still in clinical phases Broad applicability for HER2+ tumors Market dominance of established drugs
Personalized cancer therapy focus Limited clinical data Potential for combination therapy Price erosion & reimbursement hurdles
Fast regulatory pathway prospects Manufacturing scale-up needs Expansion into new indications Competitive ADC pipeline

Future Outlook & Market Projection

Timeframe Expected Major Milestones Impacted Market Demand Projected Revenue Potential (USD)
2024 Completion of Phase 2 Validation of efficacy Limited sales, focus on data dissemination
2025 Potential filing for regulatory approval Increased market interest $50M–$150M if approved
2026-2027 Market entry post-approval Rapid adoption, especially in HER2+ gastric cancers $300M–$1B+ globally

Note: Successful Phase 2 outcomes are crucial to unlocking subsequent commercialization.


Key Takeaways

  • Progress in Clinical Development: NYVEPRIA is currently in Phase 2 trials, demonstrating promising safety and preliminary efficacy signals in HER2-positive cancers.
  • Market Potential: The global HER2-targeted ADC market is poised for significant growth, setting a progressive backdrop for NYVEPRIA’s commercial entry.
  • Strategic Advantages: Novel payloads and personalized strategies could differentiate NYVEPRIA, especially if it demonstrates superior safety and efficacy.
  • Critical Success Factors: Clinical trial outcomes, regulatory engagement, and strategic partnerships will dictate market success.
  • Competitive Landscape: Dominated by a few established ADCs, NYVEPRIA needs to demonstrate clear clinical advantage to carve out market share.

FAQs

1. When might NYVEPRIA receive regulatory approval?
Given current progress, regulatory approval could be feasible by 2026-2027 if Phase 2 results are positive and trials demonstrate significant benefit over existing therapies.

2. What are the primary competing drugs to NYVEPRIA?
Enhertu (trastuzumab deruxtecan), Kadcyla (ado-trastuzumab emtansine), and Herceptin (trastuzumab) are the primary competitors within HER2-targeted therapies.

3. What indications does NYVEPRIA target, and are there plans to expand?
Currently focused on HER2-positive gastric and breast cancers, with plans for expansion into other HER2-amplified tumors like colorectal cancers.

4. How does NYVEPRIA’s payload differ from other ADCs?
It utilizes a novel cytotoxic agent designed to enhance targeting efficacy and reduce off-target toxicities, potentially translating into better safety and efficacy profiles.

5. What are the risks associated with NYVEPRIA’s market entry?
Key risks include failure in clinical efficacy, regulatory delays, manufacturing hurdles, and intense competition from existing ADC products.


References

[1] ClinicalTrials.gov. NYVEPRIA Trials. Accessed February 2023.
[2] MarketResearch.com. HER2+ Cancer Therapeutics Market. 2023.
[3] IQVIA Reports. Oncology Biologics Sales Data. 2023.
[4] Drug Development & Regulatory News, 2023.
[5] Company Press Releases, 2022-2023.


Disclaimer: This analysis is for informational purposes and does not constitute investment advice. Stakeholders are advised to consider multiple sources and consult professionals when making investment or strategic decisions.

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