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Soo Park, MD
Soo Park, MD
Posted: Friday, June 7, 2024
According to Axel Hauschild, MD, PhD, of the University Hospital Schleswig-Holstein, Kiel, Germany, and colleagues, daromun—a combination of two antibody-cytokine fusions L19IL2 and L19TNF—demonstrated efficacy in a phase III study of patients with unresectable melanoma. The results from the PIVOTAL trial, presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA9501), demonstrate that daromun is “an effective and safe therapeutic option for resectable, locally advanced melanoma patients.”
From 22 sites in four European Union Countries, the open-label, multicenter trial enrolled 256 patients with fully resectable, cutaneous melanoma who exhibited regional skin and/or nodal metastases. Participants were randomly assigned 1:1 to receive up to four weekly intratumoral daromun injections followed by surgery (n = 127) or surgery alone (n = 129). Daromun injections consisted of 400 μg of L19TNF and 13 Mio IU of L19IL2. Prior therapies, such as radiation, systemic therapies, and surgery, were allowed; any approved adjuvant treatment after surgery was allowed.
Relapse-free survival was evaluated by investigators and confirmed by retrospective blinded independent central review (BICR) of PET and CT scans. The median relapse-free survival among patients who received daromun plus surgery and those who underwent surgery alone was 16.7 and 6.9 months, respectively. Relapse-free survival was significantly improved among patients on daromun, according to both investigator (hazard ratio [HR] = 0.61; P = .018) and BICR (HR = 0.59; P = .005) assessments.
Distant metastasis–free survival was also significantly improved with daromun before surgery (HR = 0.60; P = .029). Furthermore, approximately 21% of patients who received neoadjuvant treatment achieved a complete pathologic response after surgery.
Low-grade, local adverse events were the most commonly reported treatment-emergent adverse events; 14% of adverse events were grade 3. Of note, no autoimmune events or drug-related deaths were reported.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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