#1 Clinical Trials Search in Europe

Encorafenib

This article explores the use of Encorafenib, a BRAF inhibitor, in various clinical trials for the treatment of different types of cancer. Encorafenib has shown promise in targeting tumors with BRAF mutations, particularly in melanoma, colorectal cancer, and non-small cell lung cancer. The trials aim to evaluate the drug’s efficacy, safety, and optimal dosing strategies, both as a single agent and in combination with other therapies.

Table of Contents

What is Encorafenib?

Encorafenib is a targeted cancer therapy drug used to treat certain types of cancers. It is also known by its brand name Braftovi and other names like PF-07263896, LGX818, ONO-7702, and W0090[1]. Encorafenib belongs to a class of drugs called BRAF inhibitors, which work by targeting a specific genetic mutation in cancer cells[2].

How Encorafenib Works

Encorafenib works by targeting a specific genetic mutation called BRAF V600. This mutation is found in some types of cancer cells and causes them to grow and divide uncontrollably. By blocking the effects of this mutation, encorafenib can help slow down or stop the growth of cancer cells[3].

The BRAF V600 mutation affects a pathway in cells called the MAPK pathway. This pathway is like a communication system that tells cells when to grow and divide. When there’s a mutation in the BRAF gene, it’s like the “off switch” for this pathway is broken, causing cells to grow out of control. Encorafenib helps fix this by turning off the faulty signal[4].

Conditions Treated with Encorafenib

Encorafenib is used to treat several types of cancers that have the BRAF V600 mutation, including:

  • Melanoma: This is a type of skin cancer. Encorafenib is used to treat advanced melanoma (melanoma that has spread to other parts of the body) or melanoma that can’t be removed by surgery[3].
  • Colorectal Cancer: Encorafenib is also used to treat advanced colorectal cancer (cancer of the colon or rectum) that has spread to other parts of the body[5].
  • Non-Small Cell Lung Cancer (NSCLC): Some studies are looking at using encorafenib to treat this type of lung cancer when it has the BRAF V600 mutation[1].

Combination Therapies

Encorafenib is often used in combination with other drugs to make the treatment more effective. Some common combinations include:

  • Encorafenib + Binimetinib: This combination is used to treat melanoma. Binimetinib is another targeted therapy that works together with encorafenib to block cancer cell growth[6].
  • Encorafenib + Cetuximab: This combination is used to treat colorectal cancer. Cetuximab is a type of drug called a monoclonal antibody that helps the immune system fight cancer cells[7].
  • Encorafenib + Binimetinib + Cetuximab: This triple combination is being studied for colorectal cancer to see if it’s more effective than other treatments[4].

Administration and Dosing

Encorafenib is taken orally (by mouth) as a capsule. The typical dose is 300 mg once daily, but this can vary depending on the specific condition being treated and whether it’s being used alone or in combination with other drugs[5]. It’s important to take encorafenib exactly as prescribed by your doctor.

Side Effects and Safety

Like all medications, encorafenib can cause side effects. Common side effects may include:

  • Fatigue (feeling tired)
  • Nausea or vomiting
  • Abdominal pain
  • Skin reactions (such as rash or itching)
  • Joint pain
  • Changes in liver function tests

Your healthcare team will monitor you closely for side effects and may adjust your dose if needed. It’s important to report any side effects you experience to your doctor[1].

Ongoing Research

Researchers are continually studying encorafenib to learn more about its effectiveness and safety. Some areas of ongoing research include:

  • Using encorafenib in combination with other drugs to treat different types of cancers[8].
  • Studying how encorafenib affects patients with liver problems[6].
  • Looking at using encorafenib earlier in the course of cancer treatment[4].
  • Investigating the use of encorafenib in patients whose cancer has returned after previous treatments[8].

These ongoing studies help doctors understand how to use encorafenib more effectively and safely to treat cancer patients.

Aspect Details
Drug Name Encorafenib (also known as LGX818, Braftovi)
Drug Class BRAF inhibitor
Target Cancers Melanoma, Colorectal Cancer, Non-Small Cell Lung Cancer, other BRAF V600 mutant solid tumors
Common Combinations Binimetinib (MEK inhibitor), Cetuximab, FOLFIRI chemotherapy
Dosage Forms Oral capsules (typically 50mg, 75mg, or 100mg)
Typical Dosing 300mg once daily, with variations based on specific trial protocols
Key Outcome Measures Overall Response Rate (ORR), Progression-Free Survival (PFS), Overall Survival (OS), Duration of Response (DOR)
Safety Monitoring Adverse events, laboratory abnormalities, ECG changes, vital signs
Pharmacokinetic Assessments Plasma concentration, AUC, Cmax, Tmax, half-life
Trial Phases Phase I, II, and III studies represented

FAQ

  • What is Encorafenib and how does it work? Encorafenib is a BRAF inhibitor that targets tumors with BRAF mutations. It works by blocking the activity of the mutated BRAF protein, which is involved in cell growth and division. By inhibiting this protein, Encorafenib can help slow down or stop the growth of cancer cells.
  • What types of cancer are being studied with Encorafenib? Clinical trials are investigating Encorafenib for various types of cancer, including melanoma, colorectal cancer, non-small cell lung cancer (NSCLC), and other solid tumors with BRAF mutations.
  • Is Encorafenib used alone or in combination with other drugs? Encorafenib is being studied both as a single agent and in combination with other drugs. Some trials are exploring its use with MEK inhibitors like Binimetinib, while others are investigating combinations with chemotherapy or other targeted therapies.
  • What are some common side effects of Encorafenib? Common side effects of Encorafenib may include skin reactions, fatigue, nausea, and liver function abnormalities. However, the specific side effects can vary depending on the dosage and combination with other drugs.
  • How is the effectiveness of Encorafenib measured in clinical trials? The effectiveness of Encorafenib is typically measured through outcomes such as overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR). These metrics help researchers assess how well the drug is working to control cancer growth and improve patient outcomes.

Ongoing Clinical Trials on Encorafenib

  • Study of encorafenib and cetuximab treatment for patients with BRAF V600E-mutant metastatic colorectal cancer who previously responded to BRAF inhibitor therapy

    Recruiting

    1 1 1
    Investigated drugs:
    Spain

  • 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 Encorafenib and Cetuximab for Patients with BRAF V600E-Mutated Localized Colon or Upper Rectum Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness of Pembrolizumab and Ipilimumab in Melanoma Patients with Brain Metastases Requiring Steroid Treatment

    Recruiting

    1 1 1
    Investigated drugs:
    Denmark

  • Study on the Safety of Encorafenib, Binimetinib, and Ribociclib for Patients with Solid Tumors

    Recruiting

    1 1 1 1
    Investigated drugs:
    Czechia France Germany Greece Hungary Italy +3

  • Study on Bevacizumab, Encorafenib, and Cetuximab for Patients with BRAF-V600E Mutated Metastatic Colorectal Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of Cetuximab, Encorafenib, and Binimetinib for Patients with Advanced Colorectal Cancer with BRAF V600E Mutation

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Maintenance Therapy with Cisplatin, Durvalumab, and Trastuzumab for Patients with Advanced Biliary Cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France

  • Study of local treatment options for large metastases in patients with BRAF V600 mutated melanoma receiving Encorafenib and Binimetinib combination therapy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Encorafenib, Cetuximab, and Pembrolizumab for Patients with Untreated BRAF V600E-Mutant Metastatic Colorectal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark France Germany Italy +6

Glossary

  • BRAF: A gene that provides instructions for making a protein involved in cell signaling and growth. Mutations in the BRAF gene can lead to uncontrolled cell growth and cancer.
  • BRAF V600E mutation: A specific mutation in the BRAF gene commonly found in certain types of cancer, particularly melanoma and colorectal cancer.
  • Encorafenib: A targeted therapy drug that inhibits the activity of mutated BRAF proteins, used in the treatment of certain cancers with BRAF mutations.
  • MEK inhibitor: A type of drug that blocks the MEK protein, which is part of the same signaling pathway as BRAF. Often used in combination with BRAF inhibitors.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • 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 that patients are still alive.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without growing or spreading.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • 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 require a reduction in dosage.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Unresectable: A tumor that cannot be removed completely through surgery.

References

  1. https://clinicaltrials.gov/study/NCT05003622
  2. https://clinicaltrials.gov/study/NCT01820364
  3. https://clinicaltrials.eu/trial/study-of-encorafenib-binimetinib-and-pembrolizumab-for-patients-with-advanced-melanoma-with-braf-v600e-k-mutation/
  4. https://clinicaltrials.gov/study/NCT03803553
  5. https://clinicaltrials.eu/trial/study-for-patients-with-metastatic-colorectal-cancer-with-braf-v600e-mutation-using-encorafenib-cetuximab-and-chemotherapy-combination/
  6. https://clinicaltrials.gov/study/NCT04759846
  7. https://clinicaltrials.gov/study/NCT05217446
  8. https://clinicaltrials.gov/study/NCT05926960