Data from phase II trials indicate that patients with resectable melanoma are likely to derive benefit from neoadjuvant immune-checkpoint inhibitors (ICIs), and that those with a major pathological response (MPR, defined as ≤10% residual viable tumour material) are unlikely to require subsequent therapy. Now, data from the phase III NADINA trial confirm these findings, as well as the superiority of this approach over adjuvant therapy with an ICI.

A total of 423 patients with resectable stage III melanoma were randomly assigned (1:1) to either 2 cycles of neoadjuvant ipilimumab plus nivolumab followed by surgery, or surgery followed by adjuvant nivolumab. Patients in the neoadjuvant group without an MPR to neoadjuvant therapy received adjuvant nivolumab or dabrafenib plus trametinib (for those with BRAF^V600E/K mutations). Event-free survival (EFS) was the primary end point.

来自 II 期试验的数据表明，可切除黑色素瘤患者可能会从新辅助免疫检查点抑制剂 （ICI） 中受益，而那些具有主要病理反应（MPR，定义为 ≤10% 残留活肿瘤物质）的患者不太可能需要后续治疗。现在，来自 III 期 NADINA 试验的数据证实了这些发现，以及这种方法优于 ICI 辅助治疗。

共有 423 名可切除的 III 期黑色素瘤患者被随机分配 （1：1） 至 2 个周期的新辅助 ipilimumab 加 nivolumab 后手术，或手术后辅助 nivolumab。新辅助治疗未获得 MPR 的新辅助组患者接受辅助纳武利尤单抗或达拉非尼加曲美替尼 （针对具有 BRAF^V600E/K 突变的患者）。无事件生存期 （EFS） 是主要终点。