CLINICAL TRIALS PROFILE FOR ZIEXTENZO

Biosimilar Clinical Trials for ZIEXTENZO

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.

All Clinical Trials for ZIEXTENZO

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.

Clinical Trial Conditions for ZIEXTENZO

Condition Name

Condition Name for ZIEXTENZO
Intervention	Trials
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma	2
Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma	2
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma	2
Ann Arbor Stage IV Hodgkin Lymphoma	1

Condition MeSH

Condition MeSH for ZIEXTENZO
Intervention	Trials
Lymphoma	6
Lymphoma, B-Cell	4
Lymphoma, Large B-Cell, Diffuse	3
Precursor Cell Lymphoblastic Leukemia-Lymphoma	2

Clinical Trial Locations for ZIEXTENZO

Trials by Country

Trials by Country for ZIEXTENZO
Location	Trials
United States	175
Canada	3
Puerto Rico	1

Trials by US State

Trials by US State for ZIEXTENZO
Location	Trials
Missouri	7
Illinois	7
Florida	7
Washington	6
Texas	6

Clinical Trial Progress for ZIEXTENZO

Clinical Trial Phase

Clinical Trial Phase for ZIEXTENZO
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

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

Clinical Trial Sponsors for ZIEXTENZO

Sponsor Name

Sponsor Name for ZIEXTENZO
Sponsor	Trials
National Cancer Institute (NCI)	9
University of Washington	2
Merck Sharp & Dohme Corp.	1

Sponsor Type

Sponsor Type for ZIEXTENZO
Sponsor	Trials
NIH	9
Other	5
Industry	2

Ziextenzo: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Ziextenzo

Ziextenzo, developed by Sandoz, is a biosimilar version of pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF) used to reduce the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer drugs. Here, we delve into the clinical trials, market analysis, and future projections for this significant biosimilar.

Clinical Trials and Approval

FDA Approval and Regulatory Journey

Ziextenzo received FDA approval in November 2019 after a lengthy regulatory process. Initially submitted for approval in December 2015, the biosimilar faced a Complete Response Letter from the FDA in 2016, necessitating additional data. A pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104) was conducted to address the FDA's concerns, comparing Ziextenzo with both US-sourced and EU-sourced reference pegfilgrastim[1][3].

Efficacy and Safety

The clinical trials demonstrated that Ziextenzo is as effective as the reference product, Neulasta. A study involving 624 breast cancer patients showed that Ziextenzo reduced the duration of neutropenia by an average of one day, similar to Neulasta[4].

Mechanism of Action

Ziextenzo contains pegfilgrastim, which binds to specific surface receptors on bone marrow cells, stimulating the production and release of neutrophils. This action helps mitigate the impact of chemotherapy on neutrophil production, reducing the risk of infections in cancer patients[4].

Market Analysis

Pricing Strategy

Sandoz launched Ziextenzo with a wholesale acquisition cost (WAC) 37% lower than that of Neulasta, the reference product. This pricing strategy aimed to increase patient access and reduce healthcare costs. As of the latest data, Ziextenzo's average sales price (ASP) has dropped significantly, to approximately $30.05 per 0.5 mg, which is 2.5- to 5.0-fold lower than its competitors[2][5].

Market Competition

Ziextenzo is the third pegfilgrastim biosimilar to enter the market, following Udenyca and Fulphila. The competitive landscape is intense, with Sandoz facing significant pressure to maintain price points that ensure patient access while remaining profitable. The steep discounts have forced Sandoz to adjust its pricing strategy and pull back in certain areas[5].

Market Share and Sales

Despite the competitive pressures, Sandoz's commitment to expanding patient access and increasing healthcare savings has been a key factor in its market strategy. However, the recent ASP data indicates that while Ziextenzo's price has stabilized at a low level, it may reach a point where it is no longer reimbursed as a separate line item but rather included in a package paid to providers[5].

Projections and Future Outlook

Sustainability and Cost Savings

The significant discounts on Ziextenzo have raised questions about the sustainability of biosimilar pricing. Sandoz continues to seek ways to create a sustainable environment for biosimilars, aiming to bring cost savings to the market while ensuring profitability. The recent spinoff from Novartis positions Sandoz to navigate these challenges independently[5].

Patient Access and Healthcare Impact

The approval and availability of Ziextenzo have expanded the oncology portfolio for Sandoz, providing physicians with a long-acting supportive oncology biosimilar option. This is particularly important given that more than 60,000 cancer patients in the US are hospitalized each year due to neutropenia, resulting in over 4,000 deaths. By reducing the incidence of febrile neutropenia, Ziextenzo can help prevent serious complications and ensure that chemotherapy treatments are not delayed or reduced[1].

Future Research and Development

As the biosimilar market continues to evolve, Sandoz is likely to focus on further research and development to maintain its competitive edge. This may include exploring new indications for Ziextenzo or developing other biosimilars to expand its portfolio.

Key Takeaways

• Clinical Efficacy: Ziextenzo has been shown to be as effective as Neulasta in reducing the incidence of febrile neutropenia.
• Pricing Strategy: Launched with a 37% discount compared to Neulasta, Ziextenzo's ASP has dropped significantly, impacting its market position.
• Market Competition: The biosimilar market for pegfilgrastim is highly competitive, with Sandoz facing challenges in maintaining profitability.
• Future Outlook: Sandoz aims to create a sustainable environment for biosimilars, focusing on cost savings and patient access.

FAQs

What is Ziextenzo used for?

Ziextenzo is used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs[1][3].

How does Ziextenzo work?

Ziextenzo contains pegfilgrastim, which stimulates the production and release of neutrophils from the bone marrow, reducing the risk of infections in cancer patients[4].

What was the pricing strategy for Ziextenzo at launch?

Ziextenzo was launched with a wholesale acquisition cost (WAC) 37% lower than that of Neulasta[2].

How has the market responded to Ziextenzo?

The market has seen significant competitive pressure, with Ziextenzo's ASP dropping to a level 2.5- to 5.0-fold lower than its competitors[5].

What are the future projections for Ziextenzo?

Sandoz aims to maintain a sustainable pricing strategy, focusing on cost savings and ensuring patient access while navigating the competitive biosimilar market[5].

Sources

1. Novartis News Release: "Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez)".
2. Biosimilars Review & Report: "Product Profile of Sandoz's Pegfilgrastim Biosimilar (Ziextenzo)".
3. Center for Biosimilars: "FDA Approves Sandoz's Pegfilgrastim Biosimilar, Ziextenzo".
4. AmeriPharma Specialty: "Ziextenzo: Preventing and Treating Febrile Neutropenia in Cancer Patients".
5. Biosimilars Review & Report: "Sandoz's Ziextenzo ASP Drops Far Below That of Competitors".