Neoadjuvant Nivolumab/Ipilimumab New Standard of Care for Stage III Melanoma

Source: OncLive, June 2024

Neoadjuvant nivolumab (Opdivo) plus ipilimumab (Yervoy) followed by therapeutic lymph node dissection (TLND) and response-driven adjuvant therapy reduced the risk of progression, recurrence, or death by 68% compared with TLND and adjuvant nivolumab alone for patients with macroscopic stage III node-positive melanoma, according to findings from the phase 3 NADINA study presented at the 2024 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine.

At the first interim analysis conducted after a median 9.9 months of follow-up, the estimated 12-month event-free survival (EFS) rate with the neoadjuvant combination of nivolumab and ipilimumab plus response-driven adjuvant therapy was 83.7% compared with 57.2% for adjuvant therapy alone (HR, 0.32; 99.9% CI, 0.15-0.66; P < .0001). This benefit remained consistent across key subgroups and a correlation was seen between pathologic complete response rates and EFS.

“This was at once the interim and the final analysis because it was highly statistically significantly positive," lead investigator Christian U. Blank, MD, PhD, Netherlands Cancer Institute (NKI-AVL), Amsterdam, Netherlands, said during a press briefing on the results. “I think NADINA defines now in melanoma that neoadjuvant immunotherapy is the new standard of care for macroscopic stage III melanoma. It is a new template for other malignancieresponse-drivens implementing an immunotherapy regimen followed by response driven activities."
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