FDA Approves Tudriqev Plus Opdivo for Advanced Melanoma That Has Progressed After PD-1 Immunotherapy

The Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) in combination with Opdivo (nivolumab) for adults with unresectable advanced cutaneous melanoma whose cancer has progressed despite treatment with a PD-1-blocking immunotherapy.

The approval offers a new treatment option for people whose melanoma has continued to grow after receiving one of today's standard immunotherapy approaches. It is based on findings showing that the combination shrank tumors in some patients and that many of those responses lasted for more than a year.

Who Is Eligible for This Treatment?

The approval is for adults with unresectable advanced cutaneous melanoma, meaning the melanoma cannot be removed with surgery, whose disease has progressed after treatment with a PD-1 inhibitor, a type of immunotherapy commonly used to treat melanoma.

Many patients receive a PD-1 inhibitor, such as Opdivo (nivolumab) or Keytruda (pembrolizumab), as part of their initial treatment. However, not everyone responds to these therapies, and some patients eventually experience disease progression. Until recently, treatment options after PD-1 therapy stopped working have been limited.

What Is Tudriqev?

Tudriqev is a genetically modified oncolytic viral therapy, meaning it uses a specially engineered virus that is injected directly into melanoma tumors.

The virus is designed to infect and destroy cancer cells while also helping stimulate the body's immune system to recognize and attack the cancer. In this approval, Tudriqev is used together with Opdivo, an immunotherapy that helps the immune system find and fight cancer cells.

How Well Did the Treatment Work?

The FDA based its decision on results from the IGNYTE clinical trial, which enrolled 140 adults with stage 3 or stage 4 unresectable melanoma whose disease had progressed after at least eight consecutive weeks of prior PD-1-based therapy.

The primary analysis included 91 patients who had at least one melanoma lesion that was not injected with Tudriqev, allowing researchers to evaluate whether treatment could also produce responses beyond the injected tumors.

The study found that:

• 24.2% of patients experienced a measurable reduction in their tumors.
• Among patients whose cancer responded, the median duration of response was 14.1 months.
• Some responses were still ongoing when the data were analyzed.

Although not every patient responded, the results provide another treatment option for patients whose melanoma has progressed after standard immunotherapy.

What Does Accelerated Approval Mean?

Tudriqev received accelerated approval, an FDA pathway that allows promising treatments for serious diseases to become available sooner based on early evidence of benefit.

Because this approval is based on tumor response and how long those responses lasted, Replimune must continue studying the combination in additional clinical trials to confirm that it provides a meaningful clinical benefit. Continued FDA approval will depend on those confirmatory results.

How Is the Treatment Given?

Unlike many cancer medicines, Tudriqev is injected directly into melanoma tumors.

Patients receive injections every two weeks for eight consecutive doses. The amount injected depends on the size and number of tumors being treated.

Opdivo is given as an intravenous (IV) infusion beginning during the third week of treatment, following its approved prescribing schedule.

Your oncology team will determine which tumors should be injected and whether this treatment approach is appropriate for you.

What Side Effects Should Patients Know About?

The prescribing information includes warnings about:

• Accidental exposure to the viral therapy
• Herpetic (herpes) infection or reactivation
• Complications related to the injection procedure
• Immune-related side effects

Your care team will monitor you for side effects throughout treatment and discuss ways to manage them if they occur.

Questions to Ask Your Doctor

If your melanoma has progressed after immunotherapy, you may want to ask your oncologist:

• Am I eligible for Tudriqev plus Opdivo?
• Why did my melanoma stop responding to PD-1 immunotherapy?
• Which of my tumors could be injected with Tudriqev?
• What benefits can I realistically expect from this treatment?
• What side effects should I watch for?
• Are there other clinical trials that may be appropriate for me?

For patients whose melanoma has progressed after PD-1 immunotherapy, the approval of Tudriqev plus Opdivo expands the available treatment options and represents another step forward in addressing a difficult-to-treat stage of the disease.

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