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Vusolimogene Oderparepvec

Vusolimogene Oderparepvec, also known as RP1, is an innovative oncolytic immunotherapy being studied in clinical trials for various types of cancer. This article explores the ongoing research into this promising treatment, which combines a modified herpes simplex virus with immune-stimulating properties to target and destroy cancer cells while activating the body’s immune system against tumors.

Table of Contents

What is Vusolimogene Oderparepvec?

Vusolimogene oderparepvec, also known as RP1, is an innovative immunotherapy drug being developed for cancer treatment[1]. It belongs to a class of treatments called oncolytic immunotherapies. Oncolytic immunotherapy uses modified viruses to target and kill cancer cells while also stimulating the body’s immune system to fight the cancer[2].

How Does it Work?

Vusolimogene oderparepvec is a genetically modified form of the herpes simplex virus type 1 (HSV-1)[2]. It has been engineered to:

  • Preferentially infect and kill cancer cells
  • Produce a protein called GM-CSF (granulocyte-macrophage colony-stimulating factor) that helps activate the immune system
  • Express a fusogenic protein that enhances its ability to spread between tumor cells
When injected into tumors, RP1 replicates within cancer cells, causing them to burst open. This releases tumor antigens that can trigger an immune response. The GM-CSF produced by the virus further stimulates the immune system to recognize and attack cancer cells throughout the body[2].

What Types of Cancers Can it Treat?

Vusolimogene oderparepvec is being studied for the treatment of several types of cancer, including:

  • Cutaneous squamous cell carcinoma (CSCC): A type of skin cancer[3]
  • Melanoma: An aggressive form of skin cancer[2]
  • Non-melanoma skin cancers (NMSC): Including basal cell carcinoma and Merkel cell carcinoma[2]
  • Non-small cell lung cancer (NSCLC)[2]
  • Triple-negative breast cancer (TNBC)[1]
It is particularly being investigated for cancers that have not responded well to other treatments, including those that have failed to respond to checkpoint inhibitor immunotherapies like PD-1 blockers[2].

How is it Administered?

Vusolimogene oderparepvec is administered through intratumoral injection. This means it is injected directly into the tumor[1][2][3]. The treatment can be given to tumors on or under the skin, and in some cases, to tumors in internal organs that can be reached with a needle under imaging guidance.

The dosing schedule and amount can vary depending on the specific clinical trial and cancer type being treated. In some studies, it is given in combination with other immunotherapy drugs, such as PD-1 inhibitors like nivolumab or cemiplimab[2][3].

Current Clinical Trials

Several clinical trials are currently underway to evaluate the safety and efficacy of vusolimogene oderparepvec:

  1. neoBREASTIM Study: This is a Phase 2 trial investigating the combination of RP1 with atezolizumab (another immunotherapy drug) for the treatment of early-stage triple-negative breast cancer[1].
  2. IGNYTE Study: This is a Phase 1/2 trial studying RP1 alone and in combination with nivolumab for various solid tumors, including melanoma, non-melanoma skin cancers, and lung cancer[2].
  3. CERPASS Study: This is a Phase 2 trial comparing cemiplimab alone to cemiplimab combined with RP1 for the treatment of advanced cutaneous squamous cell carcinoma[3].
These trials are assessing various outcomes, including tumor response rates, safety, and quality of life for patients[1][2][3].

Potential Side Effects

As with any medical treatment, vusolimogene oderparepvec may cause side effects. While the full safety profile is still being established through clinical trials, some potential side effects may include:

  • Flu-like symptoms (fever, chills, fatigue)
  • Injection site reactions (pain, redness, swelling)
  • Immune-related adverse events (as with other immunotherapies)
It’s important to note that the safety of RP1 is closely monitored in clinical trials, and patients are carefully screened for eligibility[1][2][3].

Future Prospects

Vusolimogene oderparepvec represents an exciting development in cancer immunotherapy. By combining direct tumor killing with immune system activation, it offers a potentially powerful approach to treating various cancers, especially those that have not responded well to other treatments.

As clinical trials progress, researchers hope to better understand which patients are most likely to benefit from this therapy, how best to combine it with other treatments, and how to manage any side effects. If successful, vusolimogene oderparepvec could become an important new option in the fight against cancer[1][2][3].

Aspect Details
Drug Name Vusolimogene Oderparepvec (RP1)
Type of Therapy Oncolytic immunotherapy
Administration Intratumoral injection
Cancer Types Studied Triple-negative breast cancer, melanoma, non-melanoma skin cancers, solid tumors
Key Clinical Trials neoBREASTIM, IGNYTE, CERPASS
Combination Therapies Atezolizumab, Nivolumab, Cemiplimab
Primary Endpoints Safety, tolerability, overall response rate, complete response rate
Secondary Endpoints Progression-free survival, duration of response, overall survival, quality of life measures
Patient Population Adults with various advanced or metastatic cancers, including those who have failed previous treatments
Safety Monitoring Adverse events, laboratory abnormalities, viral clearance, immune-related side effects

FAQ

  • What is Vusolimogene Oderparepvec (RP1)? Vusolimogene Oderparepvec, or RP1, is an oncolytic immunotherapy. It's a modified form of the herpes simplex virus designed to selectively infect and kill cancer cells while also stimulating the immune system to fight tumors.
  • What types of cancer is RP1 being studied for? RP1 is being investigated for several cancer types, including triple-negative breast cancer, melanoma, non-melanoma skin cancers, and other solid tumors. It's being studied both as a single agent and in combination with other immunotherapies.
  • How is RP1 administered to patients? RP1 is administered through intratumoral injection, meaning it's injected directly into the tumor. This allows for targeted delivery of the therapy to cancer cells.
  • What are the main goals of the clinical trials using RP1? The main goals include assessing the safety and effectiveness of RP1, determining the best dosage, and evaluating how well it works in combination with other cancer treatments, particularly other immunotherapies like PD-1 inhibitors.
  • Are there any specific side effects associated with RP1 treatment? While specific side effects can vary, patients are monitored for reactions related to the injection, potential viral-related symptoms, and immune-related side effects. The trials also assess how RP1 affects quality of life for patients.

Ongoing Clinical Trials on Vusolimogene Oderparepvec

  • Long-term Safety Study of Vusolimogene Oderparepvec, RP2, and RP3 in Patients with Melanoma, Liver Cancer, or Advanced Solid Tumors

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Poland Spain

  • Vusolimogene Oderparepvec with Nivolumab for Advanced Melanoma Patients Whose Cancer Progressed After Previous Immunotherapy Treatments

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Poland Spain

  • Study of Vusolimogene Oderparepvec and Nivolumab for Patients with Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France Germany Spain

  • Study of Cemiplimab Alone and with RP1 for Patients with Advanced Skin Squamous Cell Carcinoma

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Bulgaria France Germany Greece Poland Spain

Glossary

  • Oncolytic immunotherapy: A type of cancer treatment that uses viruses to infect and destroy cancer cells while also stimulating the immune system to recognize and attack tumor cells.
  • Intratumoral injection: A method of administering treatment directly into a tumor.
  • PD-1 inhibitor: A type of immunotherapy drug that blocks the PD-1 protein on immune cells, helping them to better recognize and attack cancer cells.
  • Triple-negative breast cancer (TNBC): A type of breast cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein, making it more difficult to treat with hormone therapies or drugs that target HER2.
  • Cutaneous squamous cell carcinoma (CSCC): A common type of skin cancer that develops in the squamous cells that make up the middle and outer layers of the skin.
  • Overall response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Complete response rate (CRR): The percentage of patients whose cancer completely disappears after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment or procedure.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually to shrink a tumor before surgery.

References

  1. http://clinicaltrials.eu/trial/study-of-atezolizumab-and-rp1-for-patients-with-early-stage-triple-negative-breast-cancer/
  2. http://clinicaltrials.eu/trial/study-of-vusolimogene-oderparepvec-and-nivolumab-for-patients-with-solid-tumors/
  3. http://clinicaltrials.eu/trial/study-of-cemiplimab-alone-and-with-rp1-for-patients-with-advanced-skin-squamous-cell-carcinoma/