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Inotuzumab Ozogamicin

This article summarizes clinical trials evaluating the use of inotuzumab ozogamicin, an antibody-drug conjugate, for treating various types of leukemia and lymphoma. The drug targets CD22-positive cancer cells and has shown promise in treating relapsed or refractory acute lymphoblastic leukemia (ALL) and non-Hodgkin’s lymphoma. Clinical trials have assessed its efficacy, safety, and optimal dosing when used alone or in combination with other therapies.

Table of Contents

What is Inotuzumab Ozogamicin?

Inotuzumab ozogamicin is a medication used to treat certain types of blood cancers. It is also known by the brand name Besponsa[1] and was previously called CMC-544 during its development[2]. Inotuzumab ozogamicin is a type of drug called an antibody-drug conjugate. This means it combines an antibody (a protein that targets specific cells) with a chemotherapy drug[3].

How Does Inotuzumab Ozogamicin Work?

Inotuzumab ozogamicin works by targeting a protein called CD22, which is found on the surface of certain blood cancer cells. The antibody part of the drug attaches to CD22, allowing the chemotherapy part to enter and kill the cancer cells. This targeted approach aims to destroy cancer cells while minimizing damage to healthy cells[2].

What Conditions Does Inotuzumab Ozogamicin Treat?

Inotuzumab ozogamicin is primarily used to treat blood cancers, including:

  • Acute Lymphoblastic Leukemia (ALL): This is a fast-growing cancer of the white blood cells. Inotuzumab ozogamicin is used in adults with B-cell ALL that has come back after treatment (relapsed) or has not responded to initial treatment (refractory)[1][4].
  • Non-Hodgkin’s Lymphoma (NHL): This is a group of blood cancers that start in white blood cells called lymphocytes. Inotuzumab ozogamicin has been studied in various types of NHL, including diffuse large B-cell lymphoma and follicular lymphoma[2][5].

How is Inotuzumab Ozogamicin Given?

Inotuzumab ozogamicin is given as an intravenous (IV) infusion, which means it’s delivered directly into a vein. The typical treatment schedule is:

  • One dose given weekly for 3 weeks
  • Each 3-week period is considered one treatment cycle
  • Patients may receive up to 6 cycles of treatment

The exact dose and schedule may vary depending on the specific condition being treated and how well the patient tolerates the medication[1][4].

How Effective is Inotuzumab Ozogamicin?

Clinical trials have shown promising results for inotuzumab ozogamicin in treating blood cancers:

  • In patients with relapsed or refractory ALL, inotuzumab ozogamicin led to complete remission (disappearance of all signs of cancer) in a significant number of patients[4].
  • For patients with NHL, studies have shown that inotuzumab ozogamicin can help achieve complete or partial responses (significant reduction in cancer)[6].
  • Some trials have also looked at using inotuzumab ozogamicin after stem cell transplantation to help prevent the cancer from coming back[7].

What Are the Side Effects of Inotuzumab Ozogamicin?

Like all medications, inotuzumab ozogamicin can cause side effects. Some of the most common or serious side effects include:

  • Blood-related side effects: Low blood cell counts (anemia, neutropenia, thrombocytopenia) which can increase the risk of infections, fatigue, and bleeding[3].
  • Liver problems: Including a serious condition called veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS), which can damage the liver[3].
  • Infusion-related reactions: Symptoms like fever or chills that can occur during or shortly after receiving the medication[4].
  • Gastrointestinal issues: Such as nausea, vomiting, or abdominal pain[4].
  • Fatigue: Feeling very tired is a common side effect[4].

Patients should discuss all potential side effects with their healthcare provider before starting treatment.

Ongoing Research on Inotuzumab Ozogamicin

Researchers continue to study inotuzumab ozogamicin to understand how to use it most effectively. Some areas of ongoing research include:

  • Using inotuzumab ozogamicin in combination with other cancer treatments[2][8].
  • Exploring its use in pediatric patients with ALL[9].
  • Investigating different dosing schedules to improve efficacy and reduce side effects[3].
  • Studying its effectiveness in patients with minimal residual disease (very low levels of cancer cells remaining after initial treatment)[10].

These ongoing studies aim to expand our understanding of how to best use inotuzumab ozogamicin to help patients with blood cancers.

Aspect Details
Drug Name Inotuzumab ozogamicin (also known as CMC-544)
Drug Type Antibody-drug conjugate targeting CD22-positive cells
Main Indications Relapsed/refractory acute lymphoblastic leukemia (ALL), Non-Hodgkin’s lymphoma
Administration Intravenous infusion, typically in cycles
Common Dosing 1.8 mg/m2 per cycle, often given as 3 weekly doses
Key Efficacy Measures Complete remission rates, minimal residual disease negativity, progression-free survival, overall survival
Safety Considerations Hematological toxicities, liver toxicity, veno-occlusive disease
Combination Therapies Studied with rituximab and as part of various treatment regimens
Patient Populations Adults with relapsed/refractory ALL, elderly patients, post-transplant patients
Ongoing Research Optimal dosing, efficacy in different subgroups, use in maintenance therapy

FAQ

  • What is inotuzumab ozogamicin? Inotuzumab ozogamicin is an antibody-drug conjugate that targets CD22-positive cancer cells. It consists of an anti-CD22 antibody linked to calicheamicin, a potent cytotoxic agent. The drug is being studied for treating various types of leukemia and lymphoma, particularly relapsed or refractory acute lymphoblastic leukemia (ALL).
  • What types of cancer is inotuzumab ozogamicin being studied to treat? Clinical trials are evaluating inotuzumab ozogamicin for treating CD22-positive B-cell acute lymphoblastic leukemia (ALL), particularly in relapsed or refractory cases. It is also being studied for non-Hodgkin's lymphoma, including follicular lymphoma and diffuse large B-cell lymphoma.
  • How is inotuzumab ozogamicin administered? Inotuzumab ozogamicin is typically administered intravenously in cycles. The exact dosing and schedule can vary between trials, but common regimens include weekly doses over 3-4 week cycles. For example, one trial used 1.8 mg/m2 given in 3 weekly doses over a 28-day cycle.
  • What are some of the main outcomes being measured in these clinical trials? Key outcomes being evaluated include complete remission rates, minimal residual disease negativity, progression-free survival, overall survival, duration of remission, and safety/tolerability. Trials are also assessing factors like the optimal dosing regimen and the drug's efficacy in different patient populations.
  • What are some of the potential side effects of inotuzumab ozogamicin? Common side effects being monitored include hematological toxicities (like neutropenia and thrombocytopenia), liver toxicity, and veno-occlusive disease. Trials are carefully evaluating the safety profile, including the incidence of adverse events and how they may differ in various patient groups or dosing regimens.

Ongoing Clinical Trials on Inotuzumab Ozogamicin

  • Study of Inotuzumab Ozogamicin and drug combination in adult patients with B-cell Acute Lymphoblastic Leukemia who have minimal residual disease before stem cell transplantation

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

  • Study Comparing Inotuzumab Ozogamicin to Drug Combination for Children with High-Risk Relapsed B-cell Acute Lymphoblastic Leukemia

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +10

  • Study of Inotuzumab Ozogamicin Alone and with Drug Combination for Children with Relapsed or Refractory Acute Lymphoblastic Leukemia

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +7

  • Study on Tioguanine and Drug Combination for Patients Aged 0-45 with Newly Diagnosed Acute Lymphoblastic Leukemia

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Denmark Estonia Finland France Germany +8

  • Testing inotuzumab ozogamicin and blinatumomab with drug combination for children with relapsed precursor B-cell acute lymphoblastic leukemia

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Austria Czechia Denmark Finland France Germany +5

Glossary

  • Antibody-drug conjugate: A type of targeted cancer therapy that combines a monoclonal antibody with a potent cytotoxic agent. The antibody helps deliver the drug specifically to cancer cells expressing the target antigen.
  • CD22: A protein found on the surface of B cells. CD22 is the target for inotuzumab ozogamicin.
  • Acute lymphoblastic leukemia (ALL): A type of blood cancer that affects lymphoid-lineage cells. It progresses rapidly and results in the accumulation of immature lymphoblasts.
  • Non-Hodgkin's lymphoma: A group of blood cancers that develop from lymphocytes. It includes subtypes like follicular lymphoma and diffuse large B-cell lymphoma.
  • Complete remission (CR): The disappearance of all signs of cancer in response to treatment. In leukemia, this typically means less than 5% blasts in the bone marrow and no evidence of disease elsewhere.
  • Minimal residual disease (MRD): Small numbers of cancer cells that remain after treatment, often below the level detectable by standard tests. MRD negativity is an important measure of treatment efficacy.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without their cancer progressing or worsening.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.
  • Veno-occlusive disease (VOD): A potentially serious liver complication that can occur after certain cancer treatments, particularly stem cell transplants. It involves blockage of small veins in the liver.
  • Hematopoietic stem cell transplantation (HSCT): A procedure where healthy blood stem cells are transplanted to replace diseased or damaged bone marrow. It's often used as a treatment for leukemia and lymphoma.

References

  1. https://clinicaltrials.gov/study/NCT05687032
  2. https://clinicaltrials.gov/study/NCT00299494
  3. https://clinicaltrials.gov/study/NCT03677596
  4. https://clinicaltrials.gov/study/NCT01564784
  5. https://clinicaltrials.gov/study/NCT01232556
  6. https://clinicaltrials.gov/study/NCT00868608
  7. https://clinicaltrials.gov/study/NCT03104491
  8. https://clinicaltrials.gov/study/NCT01055496
  9. https://clinicaltrials.gov/study/NCT05748171
  10. https://clinicaltrials.gov/study/NCT05456698