What is the duration of adjuvant therapy for melanoma?

From the Guidelines

Adjuvant therapy for melanoma is typically given for 52 weeks in patients with resected stage IIIA-D disease that is BRAF wild-type, with options including nivolumab or pembrolizumab. This recommendation is based on the most recent and highest quality study, which suggests that these adjuvant therapy options should be offered to patients with resected stage IIIA-D disease that is BRAF wild-type 1. The study, published in the Journal of Clinical Oncology in 2023, provides high-quality evidence that supports the use of nivolumab or pembrolizumab for 52 weeks in this patient population.

Some key points to consider when administering adjuvant therapy for melanoma include:

• Nivolumab and pembrolizumab are both US Food and Drug Administration (FDA)–approved adjuvant treatments for patients with melanoma with lymph node involvement who have undergone complete disease resection 1
• Patients with stage IIIA disease with <1 mm involvement in the sentinel lymph node have a relatively better prognosis and lower risk of relapse, and treatment should be individualized after discussing risk-benefit quotient with these patients 1
• Regular monitoring during treatment includes clinical examinations, laboratory tests, and imaging studies to assess for both treatment efficacy and potential adverse effects

It's worth noting that the duration and type of adjuvant therapy may vary depending on individual patient factors, such as the presence of BRAF mutations or other comorbidities. However, based on the current evidence, 52 weeks of adjuvant therapy with nivolumab or pembrolizumab is the recommended treatment duration for patients with resected stage IIIA-D disease that is BRAF wild-type 1.

From the FDA Drug Label

The safety of OPDIVO as a single agent was evaluated in CHECKMATE-76K, a randomized (2:1), double-blind trial in 788 patients with completely resected Stage IIB/C melanoma who received OPDIVO 480 mg by intravenous infusion over 30 minutes every 4 weeks (n=524) or placebo by intravenous infusion over 30 minutes every 4 weeks (n=264) for up to 1 year CHECKMATE-238 (NCT02388906) was a randomized, double-blind trial in 906 patients with completely resected Stage IIIB/C or Stage IV melanoma Patients were randomized (1:1) to receive OPDIVO 3 mg/kg by intravenous infusion every 2 weeks or ipilimumab 10 mg/kg intravenously every 3 weeks for 4 doses then every 12 weeks beginning at Week 24 for up to 1 year.

The duration of adjuvant therapy with nivolumab in melanoma is up to 1 year 2.

From the Research

Adjuvant Therapy Duration for Melanoma

• The duration of adjuvant therapy for melanoma is not explicitly stated in the provided studies 3, 4, 5, 6, 7.
• However, the studies discuss the recommended adjuvant therapies for patients with completely resected cutaneous or mucosal melanoma with a high risk of recurrence, including nivolumab, pembrolizumab, or dabrafenib-trametinib for patients with BRAF V600E or V600K mutations 3.
• The studies also mention that adjuvant treatment is recommended for patients with stage IIIB-IIID melanoma, and may be considered for patients with stage IIIA melanoma 6.
• Additionally, the studies discuss the efficacy and safety of pembrolizumab in the adjuvant treatment of melanoma, with a focus on its use in patients with resected stage III or IV melanoma 4, 6.
• It is worth noting that the optimal duration of adjuvant therapy for melanoma may depend on various factors, including the patient's individual risk of recurrence and the specific treatment regimen used 5, 6.

Factors Influencing Adjuvant Therapy Duration

• The choice of adjuvant therapy and its duration may be influenced by factors such as the patient's BRAF mutation status, the stage of the disease, and the presence of other prognostic factors 3, 6.
• The studies suggest that molecular testing should be conducted to help guide treatment decisions, including the selection of adjuvant therapy and its duration 3.
• The optimal duration of adjuvant therapy for melanoma may also depend on the results of ongoing clinical trials and the emergence of new treatment options 5, 7.

Ongoing Research and Future Directions

• The studies highlight the need for further research to determine the optimal duration of adjuvant therapy for melanoma and to identify prognostic and predictive biomarkers that can help guide treatment decisions 5, 6.
• The use of immune checkpoint inhibitors and targeted therapies in the adjuvant setting is a rapidly evolving field, and ongoing clinical trials are investigating new treatment regimens and combinations 4, 7.