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Ivonescimab

Ivonescimab is an innovative bispecific antibody that targets both PD-1 and VEGF-A, showing promise in treating various types of cancer. This article summarizes the ongoing clinical trials investigating the efficacy and safety of Ivonescimab, either alone or in combination with other treatments, for different cancer types including lung cancer, skin cancer, and biliary tract cancer.

Table of Contents

What is IVONESCIMAB?

IVONESCIMAB, also known as AK112 or SMT112, is a new type of cancer drug that is currently being studied in clinical trials[8]. It belongs to a class of medications called bispecific antibodies, which means it can target two different things at once. In this case, IVONESCIMAB targets both PD-1 and VEGF[7].

PD-1 is a protein on immune cells that cancer cells can use to hide from the immune system. VEGF is a protein that helps cancer cells grow new blood vessels. By targeting both of these proteins, IVONESCIMAB aims to help the immune system fight cancer while also cutting off the cancer’s blood supply[7].

How Does IVONESCIMAB Work?

IVONESCIMAB works in two main ways:

  1. Boosting the immune system: By blocking PD-1, IVONESCIMAB helps your immune cells recognize and attack cancer cells more effectively.
  2. Starving the tumor: By targeting VEGF, IVONESCIMAB helps prevent the formation of new blood vessels that feed the tumor, potentially slowing or stopping its growth.

This dual action makes IVONESCIMAB a promising candidate for treating various types of cancer[7].

Cancers Treated with IVONESCIMAB

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

  • Non-small cell lung cancer (NSCLC): This is the most common type of lung cancer[8].
  • Glioblastoma: A type of aggressive brain cancer[1].
  • Cutaneous squamous cell carcinoma: A type of skin cancer[2].
  • Small cell lung cancer: Another type of lung cancer[3].
  • Biliary tract cancer: Cancer that occurs in the bile ducts[4].
  • Pancreatic cancer[5].
  • Esophageal squamous cell carcinoma: A type of cancer in the esophagus[6].
  • Hepatocellular carcinoma: The most common type of liver cancer[7].
  • Head and neck squamous cell carcinoma[9].

Clinical Trials and Research

IVONESCIMAB is currently being studied in various clinical trials. These trials are designed to test how well the drug works and how safe it is. Some key points about the ongoing research include:

  • Different stages of research: There are trials in Phase 1, 2, and 3. Phase 1 trials focus on finding the right dose, Phase 2 trials test how well the drug works, and Phase 3 trials compare the new drug to existing treatments[1][8].
  • Combination therapies: Many trials are testing IVONESCIMAB in combination with other treatments like chemotherapy or radiation therapy[5][9].
  • Different treatment settings: Some trials are looking at using IVONESCIMAB before surgery (neoadjuvant therapy), after surgery (adjuvant therapy), or for cancers that have spread (metastatic cancer)[9][8].

Potential Side Effects

As with all medications, IVONESCIMAB may cause side effects. In clinical trials, researchers carefully monitor patients for any adverse events. Common side effects of immunotherapy drugs like IVONESCIMAB can include:

  • Fatigue
  • Skin rashes
  • Diarrhea
  • Nausea
  • Fever

More serious side effects are possible but less common. It’s important to remember that not everyone experiences side effects, and they can vary from person to person. In clinical trials, doctors use a system called the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) to grade the severity of side effects[1][2].

Future Prospects

IVONESCIMAB shows promise in treating various types of cancer, especially those that have been difficult to treat with existing therapies. The ongoing clinical trials will help determine:

  • How effective IVONESCIMAB is compared to current treatments
  • Which types of cancer respond best to this drug
  • The optimal dosing and treatment schedule
  • Long-term safety and efficacy

If the results from these trials are positive, IVONESCIMAB could become an important new option for cancer treatment in the future[8][7].

Cancer Type Trial Phase Combination Therapy Primary Outcome Measure
Cutaneous Squamous Cell Carcinoma Phase 2 Ivonescimab alone Safety and adverse events
Glioblastoma Phase 1/2 Ivonescimab alone Safety and adverse events
Salivary Gland Cancer Phase 2 Ivonescimab alone Objective Response Rate (ORR)
Colon Cancer Phase 2 Ivonescimab + CAPOX chemotherapy Pathologic complete response
Esophageal Cancer Phase 2 Ivonescimab + chemotherapy Pathological complete response
Small Cell Lung Cancer Phase 2 Ivonescimab + irinotecan liposome Objective Response Rate (ORR)
Biliary Tract Cancer Phase 2 Ivonescimab vs. FOLFOX chemotherapy Progression-free survival (PFS)
Thymic Cancer Phase 2 Ivonescimab + chemotherapy 6-month progression-free survival rate

FAQ

  • What is Ivonescimab? Ivonescimab is a bispecific antibody that targets both PD-1 (a protein involved in immune regulation) and VEGF-A (a protein involved in blood vessel growth). It's designed to enhance the body's immune response against cancer cells while also reducing the blood supply to tumors.
  • What types of cancer are being studied with Ivonescimab? Clinical trials are investigating Ivonescimab for various cancer types, including cutaneous squamous cell carcinoma (a type of skin cancer), glioblastoma (a brain cancer), salivary gland cancer, colon cancer, esophageal cancer, small cell lung cancer, biliary tract cancer, and thymic cancer.
  • How is Ivonescimab administered? Ivonescimab is typically administered intravenously (through a vein) every 3 weeks. The dosage may vary depending on the specific trial and cancer type being studied.
  • What are the potential side effects of Ivonescimab? While specific side effects are still being studied, common side effects of cancer immunotherapies can include fatigue, skin reactions, and immune-related adverse events. The trials are closely monitoring patients for any adverse reactions to ensure safety.
  • How long do patients typically receive Ivonescimab treatment in these trials? The duration of treatment varies by trial, but patients often receive Ivonescimab until disease progression, unacceptable toxicity, or for a maximum specified period (e.g., up to 24 months in some trials). Some studies also include follow-up periods to assess long-term outcomes.

Ongoing Clinical Trials on Ivonescimab

  • Study of ivonescimab alone or with ligufalimab versus pembrolizumab for patients with recurrent or metastatic head and neck squamous cell cancer

    Recruiting

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

  • Study of ivonescimab with chemotherapy combination for first and second-line treatment in patients with advanced or metastatic gastric and gastroesophageal cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Ivonescimab for Treating Relapsed Pleural Mesothelioma in Patients After Immunotherapy and Chemotherapy

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study Comparing Ivonescimab to FOLFOX Drug Combination for Patients with Advanced Biliary Tract Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study Comparing Ivonescimab with Chemotherapy to Pembrolizumab with Chemotherapy for Patients with Metastatic Squamous Non-Small Cell Lung Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Greece Ireland Italy +3

  • A Study of Ivonescimab Combined with Fluorouracil, Folinic Acid, and Oxaliplatin Compared to Bevacizumab for Patients with Metastatic Colorectal Cancer

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Czechia France Germany Hungary Italy +2

  • Study Comparing Ivonescimab and Chemotherapy with Pembrolizumab and Chemotherapy for Patients with Metastatic Squamous Non-small Cell Lung Cancer

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Ireland Italy Poland +1

  • Study on the Effect of Ivonescimab, Pemetrexed, and Carboplatin in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutation After Previous Treatment

    Not recruiting

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

Glossary

  • Bispecific antibody: A type of engineered antibody that can bind to two different targets simultaneously, in this case, PD-1 and VEGF-A.
  • PD-1: Programmed Death-1, a protein on immune cells that acts as a checkpoint to prevent the immune system from attacking the body's own tissues.
  • VEGF-A: Vascular Endothelial Growth Factor-A, a protein that stimulates the formation of blood vessels, including those that supply tumors.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually to shrink a tumor before surgery.
  • Objective 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 or diagnosis that patients are still alive.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • Quality of Life (QoL): A measure of an individual's well-being and ability to carry out daily activities while undergoing treatment.

References

  1. https://clinicaltrials.gov/study/NCT06672575
  2. https://clinicaltrials.gov/study/NCT06567314
  3. https://clinicaltrials.gov/study/NCT06478043
  4. https://clinicaltrials.eu/trial/study-comparing-ivonescimab-to-folfox-drug-combination-for-patients-with-advanced-biliary-tract-cancer/
  5. https://clinicaltrials.gov/study/NCT06491472
  6. https://clinicaltrials.gov/study/NCT06489197
  7. https://clinicaltrials.gov/study/NCT06375486
  8. https://clinicaltrials.gov/study/NCT05184712
  9. https://clinicaltrials.gov/study/NCT06444009