#1 Clinical Trials Search in Europe

Valemetostat Tosilate

Valemetostat Tosylate is an investigational drug being studied in clinical trials for various types of lymphomas, including peripheral T-cell lymphoma, B-cell lymphoma, and Hodgkin lymphoma. These trials aim to evaluate the safety, efficacy, and optimal dosing of Valemetostat Tosylate as a single agent or in combination with other anti-lymphoma treatments for patients with relapsed or refractory disease.

Table of Contents

What is Valemetostat Tosilate?

Valemetostat Tosilate, also known as DS-3201b, is a new medication being studied for the treatment of various types of lymphomas[1]. It belongs to a class of drugs called EZH2 inhibitors, which work by targeting a specific protein involved in cancer growth[2].

How Does Valemetostat Tosilate Work?

Valemetostat Tosilate works by inhibiting the EZH2 protein, which is involved in regulating gene expression. In some types of lymphoma, this protein becomes overactive, leading to uncontrolled cell growth. By blocking EZH2, Valemetostat Tosilate aims to slow down or stop the growth of cancer cells[2].

Which Conditions Does Valemetostat Tosilate Treat?

Valemetostat Tosilate is being studied for the treatment of several types of lymphomas that have relapsed (come back) or become refractory (stopped responding to previous treatments). These include:

  • Peripheral T-cell Lymphoma (PTCL): A group of aggressive T-cell lymphomas[1]
  • Adult T-cell Leukemia/Lymphoma (ATL): A rare and aggressive type of T-cell lymphoma[1]
  • B-cell Lymphomas, including:
    • Diffuse Large B-cell Lymphoma (DLBCL)
    • Follicular Lymphoma (FL)
    • Mantle Cell Lymphoma (MCL)
    • Marginal Zone Lymphoma (MZL)
    • Hodgkin Lymphoma (HL)[3]

How is Valemetostat Tosilate Administered?

Valemetostat Tosilate is taken orally as a film-coated tablet. In clinical trials, it is typically administered at a dose of 200 mg per day in continuous 28-day cycles[1]. The treatment continues until the disease progresses or unacceptable side effects occur.

Clinical Trials and Research

Several clinical trials are currently underway to evaluate the safety and effectiveness of Valemetostat Tosilate:

  • A Phase 2 study is examining its use as a single agent in patients with relapsed or refractory Peripheral T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma[1].
  • Another Phase 2 study is investigating its effectiveness in various types of relapsed or refractory B-cell lymphomas[3].
  • A Phase 1/2 study is looking at the combination of Valemetostat Tosilate with other anti-lymphoma agents in patients with relapsed or refractory Non-Hodgkin Lymphomas[2].

These studies aim to determine how well patients respond to the treatment, how long the responses last, and what side effects may occur.

Potential Side Effects

As Valemetostat Tosilate is still in clinical trials, the full range of potential side effects is not yet known. However, researchers are closely monitoring patients for any adverse reactions. Some areas of concern being watched include:

  • Effects on blood cell counts
  • Liver function
  • Heart rhythm changes (QT prolongation)
  • Infections
  • Gastrointestinal issues[1][3]

It’s important to note that not all patients will experience these side effects, and the benefits of treatment may outweigh the risks for many patients with relapsed or refractory lymphomas.

Conclusion

Valemetostat Tosilate represents a promising new approach to treating various types of relapsed or refractory lymphomas. By targeting the EZH2 protein, it offers hope for patients who have exhausted other treatment options. While more research is needed to fully understand its effectiveness and safety profile, early clinical trials are providing valuable insights into this innovative therapy.

If you have a relapsed or refractory lymphoma and are interested in learning more about Valemetostat Tosilate, speak with your healthcare provider about whether participating in a clinical trial might be appropriate for you.

Aspect Details
Drug Name Valemetostat Tosylate (DS-3201b)
Drug Type EZH2 inhibitor
Administration Oral, film-coated tablet
Dosage Typically 200 mg/day in continuous 28-day cycles
Target Conditions Relapsed/Refractory Peripheral T-cell Lymphoma, B-cell Lymphoma, Hodgkin Lymphoma
Trial Phases Phase I/II and Phase II
Primary Objectives Safety, tolerability, efficacy (Objective Response Rate)
Secondary Objectives Pharmacokinetics, Duration of Response, Complete Response Rate, Progression-Free Survival
Key Eligibility Criteria Adult patients with relapsed/refractory lymphomas, specific prior treatments, adequate organ function
Exclusion Criteria Prior EZH2 inhibitor exposure, active CNS involvement, certain cardiovascular conditions

FAQ

  • What is Valemetostat Tosylate? Valemetostat Tosylate is an investigational drug being studied for the treatment of various types of lymphomas. It is an EZH2 inhibitor, which means it targets a specific protein involved in cancer cell growth.
  • What types of lymphomas are being studied with Valemetostat Tosylate? Clinical trials are investigating Valemetostat Tosylate for several types of lymphomas, including peripheral T-cell lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Hodgkin lymphoma.
  • How is Valemetostat Tosylate administered? Valemetostat Tosylate is administered orally as a film-coated tablet. The typical dosage being studied is 200 mg per day, taken continuously in 28-day cycles.
  • What are the main goals of these clinical trials? The main goals of these trials are to assess the safety and effectiveness of Valemetostat Tosylate, determine the optimal dosage, evaluate how well patients respond to the treatment, and measure how long the responses last.
  • Who is eligible to participate in these clinical trials? Eligibility varies by trial, but generally includes adult patients with relapsed or refractory lymphomas who have received prior treatments. Specific criteria may include certain types of lymphoma, number of previous therapies, and overall health status.

Ongoing Clinical Trials on Valemetostat Tosilate

  • A Study of Valemetostat Tosylate in Adult Patients with Advanced Solid Tumors That Have Specific Gene Changes or Are Clear Cell Endometrial or Ovarian Cancers

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of valemetostat tosylate tablets in patients with relapsed or refractory B-cell lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and Hodgkin lymphoma

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

  • Study on Golcadomide and Valemetostat Tosylate for Patients with Relapsed or Refractory Non-Hodgkin Lymphomas

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

  • Study of Valemetostat Tosylate with Drug Combination for Patients with Previously Treated Solid Tumors

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study comparing valemetostat tosylate plus pembrolizumab versus pembrolizumab alone in patients with advanced non-small cell lung cancer with high PD-L1 expression

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study of Valemetostat Tosylate for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

Glossary

  • Relapsed/Refractory: Refers to cancer that has returned after treatment (relapsed) or has not responded to initial treatment (refractory).
  • Peripheral T-cell Lymphoma (PTCL): A group of aggressive T-cell lymphomas that develop from mature T cells.
  • B-cell Lymphoma: A type of cancer that begins in B lymphocytes, a kind of white blood cell that is part of the immune system.
  • Hodgkin Lymphoma: A type of lymphoma characterized by the presence of Reed-Sternberg cells.
  • EZH2 inhibitor: A type of drug that blocks the action of the EZH2 protein, which is involved in cancer cell growth.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Complete Response (CR): The disappearance of all signs of cancer in response to treatment.
  • Partial Response (PR): A decrease in the size of a tumor or in the extent of cancer in the body in response to treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it worsening.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without growing or spreading.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or level of use.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug recommended for further testing in Phase 2 clinical trials based on Phase 1 results.

References

  1. http://clinicaltrials.eu/trial/study-of-valemetostat-tosylate-for-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma/
  2. http://clinicaltrials.eu/trial/study-on-golcadomide-and-valemetostat-tosylate-for-patients-with-relapsed-or-refractory-non-hodgkin-lymphomas/
  3. http://clinicaltrials.eu/trial/study-of-valemetostat-tosylate-for-patients-with-relapsed-or-refractory-b-cell-lymphoma/