#1 Clinical Trials Search in Europe

Fianlimab

Fianlimab, an experimental immunotherapy drug, is currently being studied in several clinical trials for its potential to treat various types of cancer. These trials are investigating the effectiveness and safety of Fianlimab, often in combination with other immunotherapy drugs like Cemiplimab, in treating melanoma, non-small cell lung cancer, renal cell carcinoma, colorectal cancer, and bladder cancer. The research aims to determine if Fianlimab can improve patient outcomes and provide new treatment options for cancer patients.

Table of Contents

What is Fianlimab?

Fianlimab, also known as REGN3767, is an experimental drug being studied for the treatment of various types of cancer[1]. It belongs to a class of medications called immune checkpoint inhibitors, which help the body’s immune system fight cancer cells[1]. Fianlimab is specifically designed to target a protein called LAG-3 (Lymphocyte Activation Gene-3) on immune cells[2].

How Fianlimab Works

Fianlimab works by blocking the LAG-3 protein on immune cells. LAG-3 is a protein that can prevent immune cells from effectively attacking cancer cells. By blocking LAG-3, fianlimab helps to “take the brakes off” the immune system, allowing it to recognize and destroy cancer cells more effectively[2].

Conditions Treated with Fianlimab

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

  • Melanoma: A type of skin cancer[1]
  • Non-Small Cell Lung Cancer (NSCLC): A common type of lung cancer[3]
  • Renal Cell Carcinoma: A type of kidney cancer[4]
  • Colorectal Cancer: Cancer of the colon or rectum[5]
  • Cutaneous Squamous Cell Carcinoma (CSCC): Another type of skin cancer[6]
  • Bladder Cancer: Specifically, muscle-invasive bladder cancer[7]

Combination Therapy with Fianlimab

In most clinical trials, fianlimab is being studied in combination with other cancer treatments, particularly another immune checkpoint inhibitor called cemiplimab (also known as REGN2810 or Libtayo)[1][3]. This combination approach aims to enhance the immune system’s ability to fight cancer from multiple angles.

Some studies are also exploring the use of fianlimab with other treatments, such as:

  • Chemotherapy drugs like gemcitabine and cisplatin for bladder cancer[7]
  • Ipilimumab, another immunotherapy drug, for melanoma[8]

Current Clinical Trials

Fianlimab is currently being studied in several clinical trials for different types of cancer. These trials are designed to evaluate:

  • The effectiveness of fianlimab in treating various cancers[1][3]
  • The safety of fianlimab and its potential side effects[1]
  • How fianlimab compares to or combines with other cancer treatments[2][9]
  • The appropriate dosage and administration schedule for fianlimab[1]

These trials are being conducted in various stages of cancer, from early-stage to advanced or metastatic disease.

Potential Side Effects

As with all medications, fianlimab may cause side effects. The clinical trials are carefully monitoring for any adverse events. Some potential side effects being studied include:

  • Immune-mediated adverse events: These are side effects caused by an overactive immune system[3]
  • Fatigue: Feeling very tired[3]
  • Skin reactions: Such as rash or itching[1]
  • Gastrointestinal issues: Like diarrhea or nausea[1]

It’s important to note that not all patients will experience these side effects, and the clinical trials are designed to carefully monitor and manage any adverse events that may occur.

Impact on Patient Quality of Life

Many of the clinical trials studying fianlimab are also assessing its impact on patients’ quality of life. This is being measured through various questionnaires that ask patients about their symptoms, physical functioning, and overall well-being[3][9]. The goal is to ensure that any potential benefits of the treatment outweigh any negative impacts on patients’ daily lives.

In conclusion, fianlimab represents a promising new approach in cancer treatment. While it’s still in the experimental stage, the ongoing clinical trials are providing valuable information about its effectiveness and safety. Patients interested in learning more about fianlimab should speak with their healthcare providers about potential clinical trial opportunities.

Aspect Details
Drug Name Fianlimab (REGN3767)
Drug Type Immunotherapy, Anti-LAG-3 antibody
Combination Therapy Often combined with Cemiplimab (REGN2810, Libtayo)
Cancer Types Studied Melanoma, Non-small cell lung cancer, Renal cell carcinoma, Colorectal cancer, Bladder cancer
Administration Intravenous (IV) infusion, typically every 3 weeks
Key Outcomes Measured Objective response rate, Progression-free survival, Overall survival, Safety and adverse events
Trial Phases Phase 2 and Phase 3 studies
Patient Population Adults with advanced or metastatic cancers
Potential Benefits Improved cancer treatment efficacy, potential for less extensive surgery, reduced risk of cancer recurrence
Ongoing Research Efficacy comparison with other immunotherapies, optimal dosing, long-term safety profile

FAQ

  • What is Fianlimab? Fianlimab, also known as REGN3767, is an experimental immunotherapy drug that targets the LAG-3 protein. It is being studied in combination with other immunotherapy drugs to treat various types of cancer.
  • What types of cancer are being studied with Fianlimab? Clinical trials are investigating Fianlimab for the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma, colorectal cancer, and bladder cancer.
  • How is Fianlimab administered? Fianlimab is typically administered through intravenous (IV) infusion every three weeks, often in combination with other immunotherapy drugs like Cemiplimab.
  • What are the potential side effects of Fianlimab? The clinical trials are studying the potential side effects of Fianlimab. Common side effects of immunotherapy drugs may include fatigue, skin reactions, and immune-related adverse events. Specific side effects for Fianlimab are still being determined through these trials.
  • How long do patients receive Fianlimab treatment in clinical trials? The duration of Fianlimab treatment varies depending on the specific trial. Some studies involve treatment for up to 17 cycles (about a year), while others may have different timeframes based on the study design and patient response to treatment.

Ongoing Clinical Trials on Fianlimab

  • Study of fianlimab plus cemiplimab with chemotherapy or cemiplimab with chemotherapy for patients with pleural mesothelioma who have not received prior treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Encorafenib, Binimetinib, Cemiplimab, and Fianlimab for Patients with BRAF-Mutated Melanoma and Brain Metastases

    Recruiting

    1 1 1
    Investigated drugs:
    Spain

  • Study on PET Imaging with Fianlimab and Cemiplimab for Patients with Advanced Solid Tumors, with or without Platinum-Based Chemotherapy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study to Compare Fianlimab and Cemiplimab Combination with Pembrolizumab in Patients with High-Risk Melanoma After Surgery

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Greece Ireland +4

  • Study on the Safety and Effectiveness of REGN5668 with Cemiplimab or Ubamatamab for Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

  • Long-term follow-up study of fianlimab and cemiplimab combination treatment in adult patients with melanoma

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Ireland

  • Study on Fianlimab and Cemiplimab for Adults with Resectable Stage III and IV Melanoma

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Greece Ireland Italy +2

  • Study on the Safety and Effectiveness of Fianlimab, Cemiplimab, and Chemotherapy in Adults with Resectable Non-Small Cell Lung Cancer

    Not recruiting

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

  • Study of Fianlimab and Cemiplimab for Patients with Untreated Advanced Melanoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Hungary +6

  • Study to Compare Fianlimab and Cemiplimab Combination with Cemiplimab Alone for Adults with Advanced Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Greece Romania Spain

Glossary

  • Fianlimab: An experimental immunotherapy drug, also known as REGN3767, that targets the LAG-3 protein and is being studied for cancer treatment.
  • Cemiplimab: An immunotherapy drug, also known as REGN2810 or Libtayo, often used in combination with Fianlimab in clinical trials.
  • Immunotherapy: A type of cancer treatment that helps your immune system fight cancer.
  • Clinical trial: A research study that tests how well new medical approaches work in people.
  • Melanoma: A type of skin cancer that develops in cells that produce melanin.
  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form of the disease.
  • Renal cell carcinoma: The most common type of kidney cancer in adults.
  • Colorectal cancer: Cancer that starts in the colon or rectum.
  • Bladder cancer: Cancer that begins in the cells of the bladder.
  • Intravenous (IV) infusion: A method of delivering medications directly into a vein.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Progression-free survival: The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall survival: The length of time from the start of treatment that patients are still alive.
  • Anti-drug antibodies: Proteins produced by the immune system that can recognize and bind to specific drugs, potentially affecting their effectiveness.

References

  1. https://clinicaltrials.eu/trial/study-on-fianlimab-and-cemiplimab-for-adults-with-resectable-stage-iii-and-iv-melanoma/
  2. https://clinicaltrials.gov/study/NCT06246916
  3. https://clinicaltrials.eu/trial/study-to-compare-fianlimab-and-cemiplimab-combination-with-cemiplimab-alone-for-adults-with-advanced-non-small-cell-lung-cancer/
  4. https://clinicaltrials.gov/study/NCT06699602
  5. https://clinicaltrials.gov/study/NCT06205836
  6. https://clinicaltrials.gov/study/NCT06384820
  7. https://clinicaltrials.gov/study/NCT06571708
  8. https://clinicaltrials.gov/study/NCT06594991
  9. https://clinicaltrials.eu/trial/study-of-fianlimab-and-cemiplimab-for-patients-with-untreated-advanced-melanoma/