Neoadjuvant Therapy

Neoadjuvant pembrolizumab can be considered for patients with high-risk node-positive disease or resectable metastatic disease based on the results of a phase II trial (SWOG S1801 [NCT03698019]). In the trial, patients who received 1 year of neoadjuvant and adjuvant pembrolizumab had improved event-free survival (EFS) compared with those who underwent primary resection and received adjuvant pembrolizumab.[24] A total of 313 patients with resectable macroscopic stage IIIB to stage IV melanoma were randomly assigned to receive either (1) three cycles of neoadjuvant pembrolizumab (200 mg intravenously [IV] every 3 weeks) followed by surgery and fifteen cycles of adjuvant pembrolizumab or (2) primary surgery followed by eighteen cycles of adjuvant pembrolizumab (200 mg IV every 3 weeks).

At a median follow-up of 15 months, the EFS rate was 72% in patients who received neoadjuvant immunotherapy and 49% in patients who received adjuvant therapy. Neoadjuvant pembrolizumab did not significantly increase toxicity in the perioperative period compared with adjuvant therapy. OS data are not available yet. The FDA has not approved this regimen, pending the completion of a randomized phase III trial.