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Alrefimotide

Alrefimotide is an investigational drug being studied in clinical trials for various types of cancer, including non-small cell lung cancer, malignant pleural mesothelioma, and ovarian cancer. This article will provide an overview of the ongoing research into alrefimotide’s potential as a cancer treatment, focusing on its use in combination with other therapies and its safety profile.

Table of Contents

What is ALREFIMOTIDE?

ALREFIMOTIDE is an investigational cancer vaccine that is being studied for the treatment of various advanced cancers. It is part of a class of drugs known as therapeutic cancer vaccines, which are designed to stimulate the body’s immune system to fight cancer cells[1]. ALREFIMOTIDE is also known by its product name UV1 and is being developed by Ultimovacs ASA[2].

The drug is composed of three synthetic peptides: alrefimotide, riletamotide, and tapderimotide. These peptides are designed to mimic certain proteins found on cancer cells, helping the immune system recognize and attack these cells[3].

How does ALREFIMOTIDE work?

ALREFIMOTIDE works by stimulating the body’s immune system to recognize and attack cancer cells. The three peptides in ALREFIMOTIDE are designed to mimic specific proteins found on cancer cells. When injected into the body, these peptides trigger an immune response, teaching the immune system to recognize these proteins as foreign and dangerous[1].

This immune response leads to the production of T-cells, a type of white blood cell that can recognize and destroy cancer cells expressing these specific proteins. By enhancing the body’s natural defense mechanisms, ALREFIMOTIDE aims to slow down or stop the growth of cancer cells and potentially shrink tumors[2].

What conditions is ALREFIMOTIDE being studied for?

ALREFIMOTIDE is currently being investigated for the treatment of several types of advanced cancers, including:

  • Non-small cell lung cancer (NSCLC): This is the most common type of lung cancer, accounting for about 80-85% of all lung cancers[1].
  • Malignant pleural mesothelioma (MPM): This is a rare and aggressive cancer that affects the lining of the lungs (pleura)[2].
  • Ovarian cancer: Specifically, ALREFIMOTIDE is being studied in patients with recurrent ovarian cancer who do not have BRCA mutations[3].

Current Clinical Trials

ALREFIMOTIDE is currently being evaluated in several clinical trials:

  1. NSCLC Trial: A phase II study investigating the efficacy and safety of ALREFIMOTIDE in combination with anti-PD-1/PD-L1 treatment for patients with advanced or metastatic non-small cell lung cancer[1].
  2. Mesothelioma Trial (NIPU-study): A study evaluating ALREFIMOTIDE in combination with nivolumab and ipilimumab as second-line treatment for patients with malignant pleural mesothelioma[2].
  3. Ovarian Cancer Trial: A randomized clinical trial investigating ALREFIMOTIDE in combination with olaparib and durvalumab as maintenance therapy in patients with recurrent ovarian cancer without BRCA mutations[3].

How is ALREFIMOTIDE administered?

ALREFIMOTIDE is administered as an intradermal injection, which means it is injected just below the skin[3]. The typical dose is 300 micrograms, although the total treatment period and frequency of administration may vary depending on the specific clinical trial and cancer type being treated[1][2][3].

Potential Side Effects

As ALREFIMOTIDE is still in clinical trials, the full range of potential side effects is not yet known. However, as with all cancer treatments, patients may experience some side effects. These could potentially include:

  • Injection site reactions (redness, swelling, or pain at the injection site)
  • Flu-like symptoms (fever, chills, fatigue)
  • Immune-related adverse events (as ALREFIMOTIDE stimulates the immune system)

It’s important to note that the safety profile of ALREFIMOTIDE is still being evaluated in clinical trials, and patients should discuss potential risks and benefits with their healthcare provider[1][2][3].

Conclusion

ALREFIMOTIDE represents a promising new approach in cancer treatment, leveraging the body’s own immune system to fight cancer cells. While still in clinical trials, it shows potential for treating various advanced cancers, including non-small cell lung cancer, malignant pleural mesothelioma, and ovarian cancer. As research continues, ALREFIMOTIDE may offer new hope for patients with these challenging cancers.

Aspect Details
Drug Name Alrefimotide (part of UV1 vaccine)
Cancer Types Studied Non-small cell lung cancer, Malignant pleural mesothelioma, Ovarian cancer
Administration Method Intradermal injection
Combination Therapies PD-1/PD-L1 inhibitors, Nivolumab, Ipilimumab, Olaparib, Durvalumab
Primary Endpoints Progression-free survival (PFS)
Secondary Endpoints Overall survival (OS), Objective response rate (ORR), Disease control rate (DCR), Safety and tolerability
Patient Population Adults with advanced or metastatic cancers, specific eligibility criteria vary by study
Key Exclusion Criteria Prior immunotherapy, active autoimmune disorders, certain concurrent medications

FAQ

  • What is Alrefimotide? Alrefimotide is an investigational drug being studied as part of a cancer vaccine called UV1. It is usually combined with other substances (riletamotide and tapderimotide) and is being tested in clinical trials for various types of cancer.
  • What types of cancer is Alrefimotide being studied for? Alrefimotide is being studied for several types of cancer, including advanced or metastatic non-small cell lung cancer, malignant pleural mesothelioma, and ovarian cancer.
  • How is Alrefimotide administered? Alrefimotide is administered as an intradermal injection, which means it is injected just under the skin.
  • What other treatments is Alrefimotide being combined with in clinical trials? In clinical trials, Alrefimotide (as part of the UV1 vaccine) is being combined with various treatments, including PD-1/PD-L1 inhibitors, nivolumab, ipilimumab, olaparib, and durvalumab.
  • What are the main goals of the clinical trials involving Alrefimotide? The main goals of these clinical trials are to evaluate the efficacy and safety of Alrefimotide in combination with other cancer treatments, assess its impact on progression-free survival, overall survival, and tumor response rates, and to study potential biomarkers for treatment response and resistance.

Ongoing Clinical Trials on Alrefimotide

  • Study of Olaparib, Durvalumab and UV1 combination as maintenance treatment for patients with recurrent ovarian cancer who do not have BRCA mutations

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Austria Belgium Denmark Finland Germany Lithuania +3

  • Study of Nivolumab, Ipilimumab, and UV1 Vaccine for Patients with Malignant Pleural Mesothelioma After Initial Chemotherapy

    Not recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Norway Spain Sweden

  • Study on the Effectiveness and Safety of UV1 Vaccine with or without Sargramostim for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

    Not recruiting

    2 1 1
    Investigated drugs:
    Norway

Glossary

  • Alrefimotide: An investigational drug being studied as part of the UV1 cancer vaccine for various types of cancer.
  • UV1: A cancer vaccine containing alrefimotide, riletamotide, and tapderimotide, being studied in clinical trials for different types of cancer.
  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form of the disease, accounting for about 80-85% of all lung cancers.
  • Malignant pleural mesothelioma (MPM): A rare and aggressive cancer that affects the lining of the lungs, often associated with asbestos exposure.
  • PD-1/PD-L1 inhibitors: A type of immunotherapy drug that helps the immune system recognize and attack cancer cells.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Disease control rate (DCR): The percentage of patients whose cancer shrinks, disappears, or remains stable after treatment.
  • ECOG performance status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Intradermal injection: A method of administering medication by injecting it just under the skin.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that can be used to indicate a normal or abnormal process, condition, or disease.
  • BRCA mutation: A genetic mutation that increases the risk of certain cancers, particularly breast and ovarian cancer.
  • Homologous recombination deficiency (HRD): A defect in a type of DNA repair mechanism that can make cancer cells more sensitive to certain treatments.
  • Patient Reported Outcomes (PROs): Information about a patient's health condition that comes directly from the patient, without interpretation by a clinician or anyone else.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-uv1-vaccine-with-or-without-sargramostim-for-patients-with-advanced-or-metastatic-non-small-cell-lung-cancer/
  2. http://clinicaltrials.eu/trial/study-of-nivolumab-ipilimumab-and-uv1-vaccine-for-patients-with-malignant-pleural-mesothelioma-after-initial-chemotherapy/
  3. http://clinicaltrials.eu/trial/study-on-olaparib-durvalumab-and-uv1-for-maintenance-therapy-in-patients-with-recurrent-ovarian-cancer-without-brca-mutation/