Neoadjuvant Intralesional Daromun (L19IL2/L19TNF) in Resectable Locally Advanced Melanoma: An Update on the Efficacy and Safety Results of the PIVOTAL Phase III Trial.

The trial enrolled 256 patients in the European Union and met its primary end point, demonstrating a statistically significant improvement in recurrence-free survival (RFS; hazard ratio, 0.59; P = .005) for daromun followed by surgery versus up-front surgery, at a median follow-up (FU) of 21 months from random assignment.

该试验在欧洲联盟共招募了256名患者，并达到了其主要终点，证明了在中位随访（FU）21个月时，接受daromun治疗后进行手术与直接手术相比，无复发生存期（RFS；风险比，0.59；P = .005）有统计学显著性改善。

PIVOTAL included two clinically distinct subgroups, namely, patients with de novo diagnosed metastatic disease (n = 34; 13%) and patients with recurrence(s) after surgery with or without radiotherapy and/or adjuvant systemic therapies (n = 222; 87%).

PIVOTAL试验包括两个临床上不同的亚组，即新诊断的转移性疾病患者（n = 34；13%）和手术后复发的患者，无论是否接受放疗和/或辅助系统治疗（n = 222；87%）。

Here, we present an updated analysis of the primary and secondary end points, including safety data, at a median FU of 36.8 months from random assignment (database cutoff: November 28, 2025), alongside new sensitivity analyses of event-free survival (EFS).

在这里，我们提供了主要和次要终点的更新分析，包括安全性数据，在随机分配后的中位随访时间为36.8个月（数据库截止日期：2025年11月28日），同时进行了新的无事件生存期（EFS）的敏感性分析。

The updated analysis confirms the clinically and statistically meaningful improvements in RFS and distant metastasis-free survival recorded in the neoadjuvant daromun versus control arm.

更新的分析确认了新辅助daromun与对照组相比，在RFS和远端转移无病生存期方面的临床和统计学意义上的改善。

The EFS post hoc analysis, conducted in both the overall population and the recurrent patient subgroups (with or without prior systemic therapies), provides consistency and robustness to the benefit of neoadjuvant daromun observed for the primary efficacy end point.

在整体人群和复发患者亚组（无论是否接受过系统治疗）中进行的EFS事后分析，为观察到的新辅助daromun对主要疗效终点的益处提供了一致性和稳健性。

No new safety signals of concern were recorded.

没有记录到新的安全性信号。