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

Source: https://onco.cc/key-papers/paper-nct02938299-j-clin-oncol-2026-update/  
OnCo record `paper-nct02938299-j-clin-oncol-2026-update` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Later report from the Neoadjuvant L19IL2 trial registered as NCT02938299, in Journal of Clinical Oncology (2026); its title describes an updated or longer-term analysis.

## Summary

Daromun (L19IL2/L19TNF) was investigated as a neoadjuvant, intralesional therapy for patients with fully resectable stage III melanoma in the phase III PIVOTAL trial (ClinicalTrials.gov identifier: NCT02938299). 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. 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%). 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). 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. 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. No new safety signals of concern were recorded.

Indexed on Europe PMC as PubMed record 42579833 (DOI 10.1200/jco-26-00852). Its abstract cites the registry id NCT02938299, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Journal of Clinical Oncology
- Year: 2026
- DOI: 10.1200/jco-26-00852
- Authors: Hauschild A, Hassel JC, Ziemer M, et al.
- What it means: A second publication from the Neoadjuvant L19IL2 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper.

## Sources

- J Clin Oncol 2026: https://doi.org/10.1200/jco-26-00852
- PubMed: https://pubmed.ncbi.nlm.nih.gov/42579833/
- Europe PMC: https://europepmc.org/article/MED/42579833
- ClinicalTrials.gov NCT02938299: https://clinicaltrials.gov/study/NCT02938299

## Connected records

- trials: [Neoadjuvant L19IL2/L19TNF- Pivotal Study](https://onco.cc/trials/nct02938299/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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