Neoadjuvant immunotherapy for melanoma is now ready for clinical practice

 Data are now available from a prospective randomized trial showing a survival benefit with neoadjuvant therapy in stage III compared to classical adjuvant therapy in stage III with pembrolizumab. These results were first presented at ESMO Congress 2022 and recently published in the New England Journal of Medicine. In the SWOG S1801 trial, one arm received primary lymphadenectomy followed by classical adjuvant therapy with 18 cycles of 200 mg pembrolizumab (a flat dose) every three weeks. In the comparator arm, three cycles of pembrolizumab were initially administered as neoadjuvant therapy, followed by surgery, and then an additional 15 cycles of pembrolizumab postoperatively. There was a remarkable improvement in prognosis in the neoadjuvant therapy arm. Here, the two-year estimated event-free survival was 72% in the neoadjuvant arm and 49% in the adjuvant group (HR=0.58, p=0.004). With only 36 deaths to date, there was still no clear advantage for overall survival (HR=0.63, p=0.18).¹

 

Given the clear advantage of event-free survival, the question for our patients is whether we can use this regimen of neoadjuvant treatment for lymph node metastasis. This treatment is not associated with increased toxicity for patients, nor is it associated with increased costs. However, there has been no approval for this type of use by regulatory agencies such as the FDA or EMA. It is also not clear whether the pharmaceutical companies in question are planning and will undertake studies relevant to approval.

 

Against this background, EADO has taken the initiative and initiated a statement on this topic. Leading dermatologists and oncologists worldwide were involved in the discussion. The statement is clear: Neoadjuvant immunotherapy for melanoma is now ready for clinical practice. This should be incorporated into standard care. The statement was published in Nature Medicine on May 16, 2023 and can be downloaded here.²

 

 

¹) Patel, S.P., et al. Neoadjuvant-Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma. N Engl J Med 388, 813-823 (2023).

²) Garbe, C., et al. Neoadjuvant immunotherapy for melanoma is now ready for clinical practice. Nat Med (2023).

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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