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Soo Park, MD
Soo Park, MD
Posted: Monday, June 3, 2024
For patients with macroscopic stage III melanoma, use of the neoadjuvant immunotherapy combination of ipilimumab plus nivolumab may result in improved clinical outcomes compared with the standard-of-care treatment strategy, according to the results of the phase III NADINA study, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA2). Given the clinical benefits observed in this patient population, this neoadjuvant strategy may prove to be a new standard of care, according to Christian U. Blank, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and colleagues.
From 2021 to 2023, a total of 423 patients with resectable, macroscopic, nodal stage III melanoma were recruited for the study. All patients were naive to treatment with immune checkpoint inhibitors, BRAF inhibitors, and MEK inhibitors. Patients were randomly assigned to receive treatment with neoadjuvant ipilimumab and nivolumab, followed by therapeutic lymph node dissection (TLND) or TLND followed by adjuvant nivolumab. For patients treated with neoadjuvant ipilimumab who did not achieve a major pathologic response, adjuvant treatment with either the kinase inhibitors dabrafenib plus trametinib or nivolumab was implemented.
The study findings revealed a significantly reduced number of events experienced by patients who received neoadjuvant therapy (28 events) compared with patients who received adjuvant therapy (72 events, hazard ratio [HR] = 0.32). In addition, the authors reported rates of 83.7% and 57.2% for 12-month event-free survival in patients treated with neoadjuvant therapy and adjuvant therapy, respectively. Furthermore, analyses of patients treated with neoadjuvant ipilimumab plus nivolumab revealed a major pathologic response in 58.0% of patients, a pathologic partial response in 8.0% of patients, a pathologic nonresponse in 26.4% of patients, and evidence of disease progression before surgery in 2.4% of patients. Moreover, 29.7% of patients treated with neoadjuvant therapy and 14.7% of patients treated with adjuvant therapy experienced systemic treatment-related adverse events.
Disclosure: For the disclosures for all study authors, visit coi.asco.org.
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