In short
Tisotumab vedotin is an investigational antibody-drug conjugate being studied in clinical trials for the treatment of various solid tumors. This article summarizes key information from multiple clinical trials evaluating tisotumab vedotin's safety, efficacy, and pharmacokinetics in patients with advanced cancers like cervical, ovarian, and lung cancer. The trials are exploring tisotumab vedotin both as a monotherapy and in combination with other cancer drugs to determine optimal dosing and identify which patients may benefit most from this targeted therapy approach.
At a glance
- Drug Name
- Tisotumab Vedotin (also known as HuMax-TF-ADC, TIVDAK)
- Drug Type
- Antibody-drug conjugate targeting tissue factor
- Cancers Studied
- Cervical, ovarian, endometrial, lung, head and neck, colorectal, pancreatic, prostate, bladder, esophageal
- Administration
- Intravenous infusion
- Dosing Schedules
- Every 3 weeks, weekly for 3 weeks with 1 week off, or other regimens
- Primary Outcomes
- Safety, tolerability, maximum tolerated dose, recommended Phase 2 dose, objective response rate
- Secondary Outcomes
- Pharmacokinetics, duration of response, progression-free survival, overall survival, disease control rate
- Common Side Effects
- Fatigue, nausea, peripheral neuropathy, eye problems, bleeding events, skin rash
- Combination Therapies
- Being studied with pembrolizumab, carboplatin, cisplatin, bevacizumab
- Trial Phases
- Phase 1, Phase 1b/2, Phase 2
What is Tisotumab Vedotin?
Tisotumab Vedotin, also known by its brand name TIVDAK, is a new type of cancer drug called an antibody-drug conjugate (ADC). This means it combines a targeted antibody with a powerful anti-cancer toxin. The drug is designed to specifically seek out and destroy cancer cells while minimizing damage to healthy cells.
How Does It Work?
Tisotumab Vedotin works by targeting a protein called tissue factor (TF), which is found in high amounts on many types of cancer cells. The antibody part of the drug attaches to this protein, and then the drug releases its toxic payload (called MMAE) inside the cancer cell, causing it to die. This targeted approach aims to be more effective and potentially less harmful than traditional chemotherapy, which can affect both healthy and cancerous cells.
What Cancers Does It Treat?
Tisotumab Vedotin is being studied for several types of advanced solid tumors, including:
- Cervical cancer: This is the main focus of many clinical trials, especially for patients whose cancer has returned or spread after previous treatments.
- Ovarian cancer: Studies are looking at its effectiveness in patients with recurrent or advanced ovarian cancer.
- Endometrial cancer: This is cancer of the lining of the uterus.
- Bladder cancer
- Prostate cancer: Particularly for castrate-resistant prostate cancer (CRPC), which no longer responds to hormone therapy.
- Esophageal cancer
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma (HNSCC)
Clinical Trials and Effectiveness
Several clinical trials have shown promising results for Tisotumab Vedotin, especially in cervical cancer. In one study, about 24% of patients with advanced cervical cancer who had previously received other treatments saw their tumors shrink significantly. This response lasted for an average of about 8.3 months.
For other cancer types, research is still ongoing to determine how effective the drug is. Some trials are comparing Tisotumab Vedotin to standard chemotherapy treatments to see if it works better or has fewer side effects.
How Is It Administered?
Tisotumab Vedotin is given as an intravenous (IV) infusion, which means it's delivered directly into your bloodstream through a vein. The most common dosing schedule is:
- 2.0 mg/kg (milligrams per kilogram of body weight) every 3 weeks
- Some trials are also testing different schedules, such as weekly treatments or different doses
Treatment usually continues until the cancer progresses or the side effects become too severe.
Side Effects
Like all cancer treatments, Tisotumab Vedotin can cause side effects. Some of the most common include:
- Eye problems: This is a significant concern, and patients often need to follow a special eye care plan.
- Fatigue: Feeling very tired is common.
- Nausea and vomiting
- Bleeding: Some patients may experience nosebleeds or other bleeding issues.
- Peripheral neuropathy: This can cause numbness, tingling, or pain in the hands and feet.
- Skin rash
Your healthcare team will monitor you closely for these and other side effects during treatment.
Ongoing Research
Researchers are continuing to study Tisotumab Vedotin to learn more about its effectiveness and safety. Current areas of investigation include:
- Combining Tisotumab Vedotin with other cancer treatments like immunotherapy (e.g., pembrolizumab) or chemotherapy (e.g., carboplatin).
- Testing different dosing schedules to find the most effective and tolerable regimen.
- Studying its effects in different populations, such as Japanese patients with solid tumors.
- Comparing Tisotumab Vedotin directly to standard chemotherapy treatments in large clinical trials.
These ongoing studies will help doctors better understand how to use Tisotumab Vedotin and which patients are most likely to benefit from it.