A New Melanoma Treatment
- The U.S. Food and Drug Administration has approved a new combination immunotherapy option for melanoma that cannot be treated with surgery (unresectable) or melanoma that has spread (metastatic).
- Opdualag is a combination of two immunotherapies — nivolumab and relatlimab. In a clinical trial, Opdualag more than doubled the median time it took for patients’ disease to progress.
- Common side effects included itching (pruritus), fatigue, and rash.
The U.S. Food and Drug Administration’s approval of Opdualag (nivolumab + relatlimab) for melanoma that cannot be treated with surgery (unresectable) or melanoma that has spread (metastatic), offers a new, potentially more powerful solution for treating this type of skin cancer, which claims about 7,700 lives per year.Read More
Details of the study:
- A total of 714 patients with previously untreated metastatic or unresectable stage 3 or 4 melanoma received either Opdualag (nivolumab 480 mg and relatlimab 160 mg) by intravenous (IV) infusion every four weeks, or nivolumab 480 mg by IV infusion every four weeks.
- Success was measured by progression-free survival (PFS), or the time to disease progression. Patients who received Opdualag had a median PFS of 10.1 months. Nivolumab alone was 4.6 months.
- The trial also measured overall survival (OS), or how long the patient can survive on the therapy. Median OS was not reached in the Opdualag arm. It was 34.1 months for nivolumab.
- The most common adverse reactions (≥20%) of Opdualag, were musculoskeletal pain, fatigue, rash, pruritus, and diarrhea.
“In my view, the increased response rate and the improved progression free survival to which is added the moderate increase in survival at three years with a 21 percent rate of grade 3-4 immune related adverse events suggests that the new regimen of nivolumab and relatlimab should replace single agent PD-1 blockade in the treatment of metastatic melanoma,” Weber says.
Understanding the side effects of immunotherapy for melanoma
What Are The Side Effects?
There were slightly more adverse effects with Opdualag (83.7%) compared to nivolumab (72.4%), and mostly included:
- Itching (pruritus)
Immune-mediated adverse events were slightly more frequent with the combination (18.6% vs 14.8%) and included:
- Thyroid abnormalities
How This Melanoma Treatment is Unique
Immunotherapy works by helping the immune system better react to cancer. The immune system typically can detect and destroy abnormal cancer cells and curb the growth of many cancers. Sometimes, though, cancer cells have a way of evading the immune system. One way they evade is by using normal “checkpoints” on cancer-fighting T-cells to essentially turn them off.
Nivolumab and relatlimab target two different checkpoints -PD-1 and LAG3 respectively — and work to turn the T-cell back on to fight the cancer. The combination of the two drugs in Opdualag is the first LAG-3 blocking antibody to be combined with a programmed death receptor-1 blocking (PD-1) antibody.
“This approval gives another active immunotherapy treatment option to patients with metastatic melanoma,” says Dr. Douglas Johnson, clinical director of melanoma at Vanderbilt-Ingram Cancer Center. “Further, it provides a new class of treatments: those targeting the molecule LAG-3. This is the first immune checkpoint inhibitor approved outside of those targeting the PD-1/PD-L1 and CTLA-4 pathways, and opens the possibility for new combinations across cancer types.”
Questions to Ask Your Doctor
- Am I a candidate for Opdualag?
- If I am, how will it work to fight my cancer?
- Will it work better than what I have used previously to treat my cancer?
- What are the side effects of Opdualag?
- How will we know if this treatment is working?
- Are there other options if this treatment is not working?
Examining your skin for melanoma