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Pivekimab Sunirine

This article discusses a clinical trial investigating the use of Pivekimab Sunirine (PVEK) in combination with a chemotherapy regimen called FLAG-Ida for treating newly diagnosed high-risk acute myeloid leukemia (AML) and other high-grade myeloid neoplasms. The study aims to determine the optimal dosage and effectiveness of this combination therapy in patients with these challenging blood cancers.

Table of Contents

What is Pivekimab Sunirine?

Pivekimab Sunirine, also known as PVEK or IMGN632, is a new drug being studied for the treatment of certain blood cancers and disorders[1]. It belongs to a class of medications called antibody-drug conjugates (ADCs), which are designed to target and kill cancer cells more precisely than traditional chemotherapy[1].

This medication is known by several other names in the medical community, including:

  • Anti-CD123 ADC IMGN632
  • Antibody-drug Conjugate IMGN632
  • CD123-targeted ADC IMGN632

How Does Pivekimab Sunirine Work?

Pivekimab Sunirine works in a unique way to target cancer cells[1]:

  1. It is a monoclonal antibody linked to a chemotherapy drug. Monoclonal antibodies are laboratory-made proteins that act like human antibodies in the immune system.
  2. The antibody part of Pivekimab Sunirine attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors.
  3. Once attached, it delivers the chemotherapy drug directly to the cancer cells, killing them.

This targeted approach is designed to be more effective at killing cancer cells while potentially causing fewer side effects compared to traditional chemotherapy that affects all rapidly dividing cells in the body[1].

Conditions Treated

Pivekimab Sunirine is being studied for the treatment of several blood disorders, including[1]:

  • Acute Myeloid Leukemia (AML): A type of blood cancer that starts in the bone marrow and quickly moves into the blood.
  • Mixed Phenotype Acute Leukemia: A rare type of leukemia that has features of both acute myeloid leukemia and acute lymphoblastic leukemia.
  • Myelodysplastic Syndrome (MDS): A group of disorders where the bone marrow doesn’t produce enough healthy blood cells.
  • Myelodysplastic/Myeloproliferative Neoplasms: Disorders that have features of both myelodysplastic syndromes and myeloproliferative neoplasms.
  • Myeloproliferative Neoplasms: A group of blood cancers where the bone marrow makes too many of certain types of blood cells.

Clinical Trial Overview

Pivekimab Sunirine is currently being studied in a Phase 1 clinical trial[1]. This trial aims to:

  1. Find the best dose of Pivekimab Sunirine when given with other chemotherapy drugs.
  2. Study how effective this combination therapy is in treating patients with newly diagnosed, high-risk acute myeloid leukemia and other high-grade myeloid neoplasms.

The trial is combining Pivekimab Sunirine with a chemotherapy regimen called FLAG-Ida, which includes the following drugs[1]:

  • Fludarabine: A chemotherapy drug that interferes with cancer cell growth.
  • Cytarabine (also known as Ara-C): Another chemotherapy drug that stops cancer cells from dividing.
  • Granulocyte Colony-Stimulating Factor (G-CSF): A medication that helps the bone marrow produce more white blood cells.
  • Idarubicin: A type of chemotherapy drug called an anthracycline that interferes with cancer cell DNA.

Treatment Process

The clinical trial for Pivekimab Sunirine involves two main phases of treatment[1]:

  1. Induction Therapy:
    • Patients receive Pivekimab Sunirine intravenously (through a vein) on day 1 or days 1 and 22.
    • They also receive the FLAG-Ida chemotherapy regimen over several days.
    • If cancer remains after the first cycle, patients may receive an additional cycle of treatment.
  2. Post-Remission Therapy:
    • For patients who achieve remission (no detectable cancer), treatment continues with Pivekimab Sunirine and high-dose cytarabine.
    • This is given every 42 days for up to 3 cycles.

Throughout the trial, patients undergo various tests, including bone marrow biopsies and blood tests, to monitor their response to treatment and any side effects[1].

Potential Benefits

The researchers hope that adding Pivekimab Sunirine to standard chemotherapy will improve outcomes for patients with high-risk blood cancers. Some potential benefits being studied include[1]:

  • Higher rates of complete remission (no detectable cancer)
  • Lower rates of measurable residual disease (very small amounts of cancer cells that remain after treatment)
  • Longer relapse-free survival (time without cancer returning)
  • Improved overall survival

Side Effects and Safety

As with any new treatment, monitoring for side effects is a crucial part of the clinical trial. The researchers are carefully tracking any adverse events (side effects) that occur during treatment[1].

Some specific safety concerns being monitored include:

  • Severe organ toxicity
  • Prolonged low blood cell counts (cytopenias)

It’s important to note that all participants in the trial are closely monitored, and the treatment can be adjusted or stopped if serious side effects occur[1].

Aspect Details
Study Type Phase 1 clinical trial
Main Drug Pivekimab Sunirine (PVEK)
Combination Therapy FLAG-Ida regimen (fludarabine, cytarabine, G-CSF, idarubicin)
Target Conditions Newly diagnosed adverse risk AML and high-grade myeloid neoplasms
Treatment Phases Induction therapy, followed by post-remission therapy
Primary Outcome Incidence of dose-limiting toxicities during cycle 1
Key Secondary Outcomes Adverse events, MRD rates, survival rates, remission rates
Follow-up Period Every 3 months for 5 years after treatment completion

FAQ

  • What is Pivekimab Sunirine (PVEK)? Pivekimab Sunirine is a targeted therapy that combines a monoclonal antibody with a chemotherapy drug. It attaches to specific molecules (CD123 receptors) on the surface of cancer cells and delivers the chemotherapy drug to kill them.
  • What conditions are being treated in this clinical trial? The trial focuses on newly diagnosed adverse risk acute myeloid leukemia (AML) and other high-grade myeloid neoplasms, including mixed phenotype acute leukemia, myelodysplastic syndrome, and myeloproliferative neoplasms.
  • What is the FLAG-Ida regimen? FLAG-Ida is a combination chemotherapy regimen that includes fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin. These drugs work together to stop the growth of cancer cells in different ways.
  • How is the treatment administered in this trial? The treatment is given in cycles. During induction therapy, patients receive PVEK intravenously along with the FLAG-Ida regimen. If remission is achieved, patients continue with post-remission therapy, receiving PVEK and high-dose cytarabine for up to 3 additional cycles.
  • What are the main outcomes being measured in this trial? The trial is measuring several outcomes, including the incidence of dose-limiting toxicities, adverse events, measurable residual disease rates, relapse-free survival, overall survival, complete remission rates, and the proportion of patients who receive stem cell transplantation after treatment.

Ongoing Clinical Trials on Pivekimab Sunirine

  • A study to evaluate the safety and how pivekimab sunirine works in children with relapsed or refractory acute myeloid leukemia

    Not yet recruiting

    1 1
    Investigated drugs:
    Belgium Czechia France Hungary Italy Spain

  • Study of IMGN632, Venetoclax, and Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

    Not recruiting

    1 1 1
    Investigated drugs:
    France Germany Italy Spain

  • Study of Pivekimab Sunirine for Adults with CD123-positive Acute Myeloid Leukemia and Other CD123-positive Blood Cancers

    Not recruiting

    1 1
    Investigated drugs:
    France Spain

Glossary

  • Acute Myeloid Leukemia (AML): A type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells that interfere with the production of normal blood cells.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. In this trial, it's part of the PVEK drug that targets specific cancer cells.
  • CD123 Receptors: Specific molecules found on the surface of certain cancer cells, which are targeted by the PVEK drug in this trial.
  • Induction Therapy: The first phase of treatment for leukemia, aimed at killing as many cancer cells as possible to achieve remission.
  • Remission: A decrease or disappearance of signs and symptoms of cancer. In this trial, achieving remission allows patients to proceed to post-remission therapy.
  • Measurable Residual Disease (MRD): The small number of cancer cells that may remain in the body during or after treatment, which can be detected by very sensitive tests.
  • Relapse-Free Survival: The length of time after achieving remission during which no cancer is found.
  • Dose-Limiting Toxicity: Side effects of a drug that are severe enough to prevent an increase in dosage or require a decrease in dosage.
  • Allogeneic Hematopoietic Cell Transplantation: A procedure where a patient receives blood-forming stem cells from a genetically similar, but not identical, donor to restore the body's ability to produce healthy blood cells.

References

  1. https://clinicaltrials.gov/study/NCT06034470