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Updated results of the phase 3 NADINA trial showed that neoadjuvant therapy with 2 cycles of nivolumab/ipilimumab outperformed 12 courses of adjuvant nivolumab in patients with stage III resectable melanoma.
The standard management of resectable, macroscopic stage III melanoma is currently surgery, which can be followed by adjuvant systemic therapy. Recently, the first results of the randomized, phase 3 NADINA trial (NCT04949113) showed that neoadjuvant therapy with only 2 cycles of nivolumab/ipilimumab outperformed adjuvant anti-PD-1 therapy in stage III resectable melanoma. Event-free survival at 12 months was 83.7% versus 57.2%, respectively, and 59% of the participants in the neoadjuvant arm achieved a major pathological response (MPR). These participants had an estimated 12-month recurrence-free survival of 95.1% [1]. Dr. Minke Lucas (Netherlands Cancer Institute, the Netherlands) presented outcomes of distant metastasis-free survival (DMFS), a secondary endpoint of the NADINA study [2].
In NADINA, 423 participants with stage III resectable melanoma were 1:1 randomized to surgery followed by 12 courses of nivolumab or to 2 courses nivolumab/ipilimumab followed by surgery. Participants with an MPR did not receive any additional treatment; participants without an MPR received 11 courses of nivolumab or dabrafinib/trametinib if they had a BRAFV600E/k mutation.
After a median follow-up of 15.4 months, DMFS in the neoadjuvant arm was superior over the adjuvant arm: estimated 18-month DMFS was 85.7% versus 62.4% (HR 0.37; 95% CI 0.24–0.57; P<0.001). This benefit was observed in both stage IIIB and stage IIIC melanoma.
In addition, final radiological and pathological responses in the neoadjuvant arm were presented. A complete radiological response was observed in 12.7%, a partial radiological response in 24.5%, and 42.9% had stable disease. A complete pathological response was observed in 49.1%, a near complete pathological response in 11.8%, a partial pathological response in 8.0%, and 27.4 had non-response. Recurrence-free survival correlated with pathological response with a 94.9% and 86.3% survival rate at 18 months for complete and partial responders, respectively, an 80.5% survival rate in participants with partial response, and a 55.1% survival rate in participants with non-response.
Based on these results, Dr. Lucas concluded that “neoadjuvant nivolumab/ipilimumab is superior to adjuvant nivolumab and should be considered as a new standard-of-care treatment.”
Medical writing support was provided by Marten Dooper.
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