If you have advanced melanoma that has kept growing after immunotherapy, your health care provider may recommend a medicine called Tudriqev (vusolimogene oderparepvec-wtpg) as part of your treatment plan.
Tudriqev is used for certain adults with a type of skin cancer called melanoma that cannot be removed with surgery and has spread. It is a genetically modified virus that is injected directly into tumors. Once inside, it multiplies and helps your immune system recognize and attack the cancer. Tudriqev is used with another medicine called nivolumab.
Below are frequently asked questions and answers about Tudriqev for advanced melanoma.
How Does Tudriqev Work to Treat Melanoma?
Tudriqev is a type of treatment called an oncolytic viral therapy. It is made from a weakened, genetically modified form of the herpes simplex virus type 1 (HSV-1), the virus that usually causes cold sores. To make Tudriqev, scientists changed the virus so it targets cancer cells and carries extra signals that help the immune system.
When Tudriqev is injected into a tumor, it works in a few ways at once:
- It multiplies inside cancer cells and causes them to burst and die. This is called tumor lysis. As the cells break apart, they release pieces of the tumor that the immune system can learn to recognize.
- It helps the immune system find the cancer. Tudriqev is engineered to make two specific therapeutic proteins. GM-CSF is a protein that helps activate immune cells, and the other protein increases direct killing of tumor cells. Together these draw immune cells called T cells to the tumor.
- It works with nivolumab. Nivolumab blocks a protein called PD-1 that cancer can use to “hide” from the immune system. In melanoma that has stopped responding to PD-1 therapy alone, adding Tudriqev may help wake the immune system back up so it can attack the cancer again.
Because the immune system works throughout the body, treating tumors that are injected may also affect tumors that were not injected. Tudriqev does not cure advanced melanoma, but it may help slow the cancer or shrink tumors.
Is Tudriqev Right for Me?
Tudriqev is not right for everyone. To help decide whether Tudriqev is an option for you, your health care provider will consider your melanoma, how far it has spread, and which treatments you have already tried.
Tudriqev is FDA-approved for adults with melanoma that meets all of the following requirements:
- The cancer is cutaneous melanoma, meaning it started in the skin.
- The cancer is advanced and cannot be removed with surgery (called “unresectable”).
- The cancer got worse during or after treatment with a PD-1 blocking immunotherapy, a type of medicine that helps the immune system fight cancer.
Tudriqev is used in combination with nivolumab, an immunotherapy that blocks a protein called PD-1, to help your immune system attack cancer cells. Your health care provider gives Tudriqev by injecting it into your tumors, and they give nivolumab through a vein.
Tudriqev received what is called “accelerated approval.” This means the FDA approved it based on early signs that tumors shrank and those responses lasted, rather than on long-term survival data. Studies are continuing to confirm the benefit, and continued approval may depend on those results. Tudriqev does not cure melanoma, but it may help shrink tumors or slow the cancer for some people. Your health care provider can help you weigh whether it fits your situation.
How Was Tudriqev Studied for Melanoma?
Tudriqev was studied in a clinical trial called IGNYTE. Everyone in the study had stage IIIB, IIIC, or IV melanoma that could not be removed with surgery. All of them had already been treated with a PD-1 immunotherapy for at least eight weeks, and their cancer had gotten worse during that treatment.
Here are some details about the 140 participants in this study:
- The middle age was 62 years, and ages ranged from 21 to 91 years.
- About 68% were male and 32% female.
- About 74% were White, and the rest listed their race as unknown.
- Everyone had already been treated with a PD-1 immunotherapy.
The study did not include people who:
- Had received prior oncolytic virus therapy
- Had untreated cancer in the brain or spinal cord
- Had certain infections such as hepatitis B, hepatitis C, or HIV or prior serious problems from HSV-1 infection
- Needed ongoing steroid medicines
What Are the Main Benefits of Tudriqev From the Study?
The main goal of the study was to measure the objective response rate, meaning the percentage of patients whose tumors shrank or disappeared on scans. Researchers also measured the duration of response (DoR; how long those responses lasted), complete response (no further signs of melanoma), and overall survival rates. Scans and measurements were done about every eight weeks. Participants were followed for a minimum of 12 months.
In the study, Tudriqev combined with nivolumab shrank tumors in some people whose melanoma had already stopped responding to PD-1 immunotherapy. You can see the specific results in the table below.
| IGNYTE: 140 Study Participants | |
|---|---|
| Objective Response Rate | 33.6% |
| Complete Response Rate | 15% |
The median DoR was 33.7 months, with 69.5% of responses ongoing at one year. Because there was no control group, the study cannot say for sure that Tudriqev treatment prolongs survival. The FDA’s accelerated approval of Tudriqev was based on response rate and durability rather than overall survival. Studies are ongoing to see if Tudriqev affects survival.
Note that your results may be different from what was seen in the study.
How Long Does It Take for Tudriqev to Work?
It is common for immunotherapy-based treatments to take time to show their full effect. In some cases, tumors may look slightly larger before they start to shrink. How quickly Tudriqev works can vary a lot from person to person, and not everyone will have a response. In the IGNYTE study, tumors were checked with scans about every eight weeks. The median time to see a response was between four and five months.
Keep in mind your results may differ from what was seen in the study. When Tudriqev did work, the benefit often lasted many months. Your response may be faster or slower than someone else’s. Your health care provider will monitor your melanoma during treatment and let you know how it is working for you.
What Are Other Unique Considerations to Be Aware Of?
Because Tudriqev is a live, modified virus, it comes with a few special considerations beyond typical cancer medicines.
Protecting the people around you
Tudriqev is based on the herpes virus, so, in rare cases, it could spread to other people through contact with your injection sites, dressings, or bodily fluids and cause a herpes-type infection. To lower this risk:
- Keep your injection site covered with the dressing for at least 48 hours, and replace the dressing if it falls off.
- Avoid touching or scratching the injection sites, and wash your hands well before and after changing a dressing.
- Have caregivers wear gloves when handling your dressings, and place used dressings and gloves in a sealed plastic bag before throwing them away in household trash.
- Avoid close contact between your injection sites or dressings and people who are pregnant, newborn babies, or anyone with a weakened immune system.
If someone is accidentally exposed (for example, by touching an uncovered injection site), they should wash the area with soap and water. If they develop signs of a herpes infection, they should contact their health care provider.
Herpes-type symptoms
Tudriqev can sometimes cause a herpes infection or reactivate one, which may show up as small bumps that turn into blisters or sores (such as cold sores). Tell your health care provider if this happens, as it can be treated. If you need to take an antiviral medicine for herpes, let your care team know. Antivirals can make Tudriqev work less well, so your health care provider may adjust the timing of your treatment.
Read this article to learn more about possible Tudriqev side effects and interactions.
Is There Any Cost Assistance Available?
Yes. The drugmaker of Tudriqev offers a patient support program called Replimune Connect Plus for eligible patients who are prescribed Tudriqev. It provides information on access to the medicine, reimbursement, and financial support, including help with understanding your insurance coverage and finding financial assistance options.
To learn more or find out if you are eligible for cost assistance, you can call 877-375-0095 or visit www.tudriqev.com. Your cancer care team, including a nurse navigator or social worker, can also help you find financial support and connect with these services.
