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Dostarlimab

Dostarlimab is an innovative immunotherapy drug being studied in various clinical trials for its potential to treat different types of cancer. These trials are exploring how dostarlimab works alone or in combination with other treatments to help the immune system fight cancer cells. The research spans multiple cancer types, including endometrial cancer, colon cancer, and melanoma, offering hope for improved outcomes in patients with advanced or hard-to-treat cancers.

Table of Contents

What is Dostarlimab?

Dostarlimab, also known by its brand name Jemperli, is an immunotherapy drug used in cancer treatment[1]. It belongs to a class of medications called programmed death receptor-1 (PD-1) blocking monoclonal antibodies. This means that Dostarlimab is a specially designed protein that helps your immune system fight cancer cells[1].

Dostarlimab is also referred to by other names in clinical trials, including TSR-042 and GSK4057190[2]. These alternative names are important for patients to recognize, as they may encounter them in medical discussions or research materials.

How Dostarlimab Works

Dostarlimab works by blocking a protein called PD-1 on the surface of immune cells. Cancer cells sometimes use PD-1 to hide from the immune system. By blocking PD-1, Dostarlimab helps your immune system recognize and attack cancer cells more effectively[3].

This type of treatment is known as immunotherapy because it enhances your body’s natural defense mechanisms to fight cancer. Unlike traditional chemotherapy, which directly attacks cancer cells but can also harm healthy cells, immunotherapy works by boosting your immune system’s ability to target cancer cells specifically.

Cancers Treated with Dostarlimab

Dostarlimab is being studied and used to treat several types of cancer, including:

  • Endometrial Cancer: Particularly in cases where the cancer has specific genetic characteristics called dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high)[4].
  • Colorectal Cancer: Especially for patients with dMMR/MSI-H colorectal cancers[5].
  • Melanoma: A type of skin cancer[3].
  • Solid Tumors in Children: Research is ongoing to evaluate Dostarlimab’s effectiveness in pediatric patients with various solid tumors[6].
  • Gestational Trophoblastic Neoplasia: A rare type of tumor that forms in the uterus during pregnancy[7].
  • Gastric (Stomach) Cancer: Particularly in cases with dMMR/MSI-H characteristics[8].

Dosage and Administration

Dostarlimab is typically administered through an intravenous (IV) infusion, which means it’s given directly into your vein. The dosage and schedule can vary depending on the specific cancer type and treatment plan, but a common regimen includes:

  • Initial phase: 500 mg every 3 weeks for the first 4 cycles
  • Maintenance phase: 1000 mg every 6 weeks for subsequent cycles[4]

The duration of treatment can last up to 2 years or until the disease progresses or unacceptable side effects occur[5]. Your healthcare team will determine the best dosage and schedule for your specific situation.

Combination Therapies

Researchers are exploring the potential benefits of combining Dostarlimab with other cancer treatments to enhance its effectiveness. Some combination therapies being studied include:

  • Dostarlimab + Niraparib: Niraparib is a drug that helps repair damaged DNA in cancer cells. This combination is being tested in colorectal cancers and other solid tumors[1][6].
  • Dostarlimab + Cabozantinib: Cabozantinib is a drug that blocks certain proteins involved in cancer growth. This combination is being studied in gynecologic cancers[9].
  • Dostarlimab + Cobolimab: Cobolimab is another immunotherapy drug. This combination is being tested in melanoma[3].

Potential Side Effects

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

  • Fatigue
  • Nausea
  • Diarrhea
  • Anemia (low red blood cell count)
  • Rash

More serious side effects, though less common, can include immune-related adverse events. These occur when the immune system becomes overactive and attacks healthy tissues. Your healthcare team will monitor you closely for any side effects and manage them appropriately[4].

Ongoing Research

Dostarlimab is the subject of numerous ongoing clinical trials aimed at expanding its use and understanding its effectiveness in various cancer types and treatment strategies. Some areas of current research include:

  • Neoadjuvant therapy: Using Dostarlimab before surgery to shrink tumors in colon cancer[5].
  • Preventing second cancers: Investigating if Dostarlimab can help prevent the occurrence of second primary cancers in patients who have been cured of their first cancer[10].
  • Combination therapies: Exploring how Dostarlimab works with other cancer treatments to improve outcomes[2].
  • Pediatric cancers: Evaluating the safety and effectiveness of Dostarlimab in children with solid tumors[6].

These ongoing studies aim to provide more treatment options and improve outcomes for cancer patients. If you’re interested in participating in a clinical trial involving Dostarlimab, discuss this possibility with your oncologist to determine if it might be appropriate for your situation.

Cancer Types Trial Phases Treatment Approaches Key Outcomes Measured
– Endometrial cancer – Colon cancer – Gastric cancer – Cholangiocarcinoma – Melanoma – Phase I – Phase II – Monotherapy – Combination therapy – Neoadjuvant treatment – Maintenance therapy – Objective Response Rate (ORR) – Progression-Free Survival (PFS) – Overall Survival (OS) – Safety and tolerability – Pathological response

FAQ

  • What is dostarlimab and how does it work? Dostarlimab is a type of immunotherapy drug called a PD-1 inhibitor. It works by helping your immune system recognize and fight cancer cells. Dostarlimab blocks a protein called PD-1 on immune cells, which allows them to attack cancer more effectively.
  • What types of cancer is dostarlimab being studied for? Clinical trials are investigating dostarlimab for various cancers, including endometrial cancer, colon cancer, gastric cancer, cholangiocarcinoma (bile duct cancer), and melanoma. It's being studied both as a single treatment and in combination with other therapies.
  • How is dostarlimab administered in clinical trials? In most trials, dostarlimab is given as an intravenous (IV) infusion. The typical dosing schedule is 500 mg every 3 weeks for the first few cycles, followed by 1000 mg every 6 weeks for subsequent cycles. However, exact dosing may vary depending on the specific trial.
  • What are some potential side effects of dostarlimab? As with any medication, dostarlimab can cause side effects. Common side effects may include fatigue, nausea, and diarrhea. More serious side effects, called immune-related adverse events, can occur when the immune system attacks healthy cells. Your healthcare team will monitor you closely for any side effects during treatment.
  • How long do patients typically receive dostarlimab in clinical trials? The duration of dostarlimab treatment varies between trials. Some studies administer the drug for a fixed number of cycles (e.g., up to 20 cycles), while others continue treatment for up to 2 years or until disease progression or unacceptable toxicity occurs. The exact duration depends on the specific trial protocol and individual patient response.

Ongoing Clinical Trials on Dostarlimab

  • Testing Drug Combinations with GSK4381562A, GSK6097608, GSK4428859 and Dostarlimab in Patients with PD-L1 Positive Head and Neck Cancer That Has Spread or Returned

    Not recruiting

    1 1 1
    Investigated drugs:
    Denmark Finland France Germany Greece Hungary +6

  • Study on the Safety and Effects of GSK4418959 and Dostarlimab for Adults with Colorectal Cancer with Mismatch Repair Deficiency or High Microsatellite Instability

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium The Netherlands Spain

  • Study on Niraparib and Dostarlimab for Patients with DNA Repair-Deficient or Platinum-Sensitive Solid Tumors

    Not recruiting

    1 1 1
    Investigated drugs:
    France

  • Study of roginolisib, dostarlimab and docetaxel combination for patients with advanced non-small cell lung cancer who did not respond to previous immunotherapy and chemotherapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Spain

  • Study on Reduced Dose Intensity of Pembrolizumab and Drug Combination for Patients with Advanced or Metastatic Cancer Responding to Standard Immunotherapy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Dostarlimab, Vitamin D3, and Drug Combination for Untreated Metastatic Pancreatic Cancer Patients

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Niraparib and Dostarlimab with Radiotherapy for Patients with Locally-Advanced Head and Neck Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of EOS884448, Dostarlimab, and Inupadenant for Patients with Advanced Solid Tumors

    Not recruiting

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

  • Study Comparing Dostarlimab and Pembrolizumab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

    Not recruiting

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

  • Study of Dostarlimab for Patients with High-Risk Locally Advanced Cervical Cancer After Chemo-Radiation

    Not recruiting

    1 1 1
    Investigated drugs:
    Spain

Glossary

  • PD-1 inhibitor: A type of drug that blocks a protein called PD-1 on immune cells, helping the immune system recognize and attack cancer cells more effectively.
  • Immunotherapy: A type of cancer treatment that helps your own immune system fight cancer.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually before surgery, to shrink a tumor or prepare the body for further treatment.
  • Objective Response Rate (ORR): The percentage 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 without the cancer getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients remain alive.
  • Adverse Events (AEs): Unexpected medical problems that happen during treatment with a drug or other therapy.
  • Microsatellite Instability-High (MSI-H): A feature of some cancers that have a high number of genetic mutations, which may make them more likely to respond to immunotherapy.
  • Mismatch Repair Deficient (dMMR): A characteristic of some cancer cells that have trouble repairing DNA errors, which can lead to more mutations and may make the cancer more responsive to certain treatments.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.

References

  1. https://clinicaltrials.gov/study/NCT06365970
  2. https://clinicaltrials.gov/study/NCT04895046
  3. https://clinicaltrials.gov/study/NCT04139902
  4. https://clinicaltrials.gov/study/NCT05728814
  5. https://clinicaltrials.gov/study/NCT05239546
  6. https://clinicaltrials.gov/study/NCT04544995
  7. https://clinicaltrials.gov/study/NCT05405192
  8. https://clinicaltrials.gov/study/NCT06059495
  9. https://clinicaltrials.gov/study/NCT05559879
  10. https://clinicaltrials.eu/trial/study-on-dostarlimab-to-prevent-second-cancer-in-patients-cured-from-primary-cancer/