NADINA trial (ASCO plenary)

Prof Dr Christian Blank, a medical oncologist at the Netherlands Cancer Institute, presented the first data from the NADINA trial at the ASCO 2024 plenary session.

This investigator-initiated trial compared neo-adjuvant ipilimumab plus nivolumab before therapeutic lymph node dissection versus adjuvant nivolumab in patients with resectable, macroscopic stage III melanoma.

The first interim analysis showed positive results, with a highly significant EFS benefit favouring the neo-adjuvant arm of ipilimumab plus nivolumab, indicated by an HR of 0.32. The estimated EFS at 12 months was 83.7% for the ipilimumab plus nivolumab group, compared to 57.2% for the adjuvant nivolumab group. This suggests that neo-adjuvant therapy should become the new standard option for macroscopic stage III melanoma.

The major pathological response was defined as less than 10% residual viable tumour cells. In this response-driven study design, nearly 60% of patients could discontinue therapy after 6 weeks of treatment, eliminating the need for additional adjuvant therapy. This represents a significant reduction in both financial and healthcare resources.

Toxicity was higher in the neo-adjuvant arm, with 30% of patients experiencing grade 3-4 toxicities, compared to 15% in the standard arm. However, most of these toxicities were manageable.

After 1 year, the EFS was 95% for major pathological responders, 76% for partial responders, and 57% for non-responders. For those patients, identifying effective adjuvant therapies, likely in combination with neo-adjuvant treatment, will be necessary.