https://doi.org/10.55788/1a7217bc
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 randomised, 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 [1]. 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%. 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 randomised 1:1 to surgery followed by 12 courses of nivolumab or 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, Dr Lucas presented the final radiological and pathological responses in the neoadjuvant arm. 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.”
- Blank CU, et al. N Engl J Med. 2024;Jun 2. DOI:10.1056/NEJMoa2402604.
- Lucas M, et al. Distant metastasis-free survival of neoadjuvant nivolumab plus ipilimumab versus adjuvant nivolumab in resectable, macroscopic stage III melanoma: the NADINA trial. Abstract LBA42, ESMO Congress 2024, 13–17 September, Barcelona, Spain.
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