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Soo Park, MD
Soo Park, MD
Posted: Thursday, July 11, 2024
Paul Lorigan, MBBCH, BAO, BA, FRCP, of Christie Hospital NHS Foundation Trust, Manchester, United Kingdom, and colleagues evaluated the use of UV1—a vaccine that generates T-cell responses against the cancer antigen telomerase—in combination with the immunotherapies ipilimumab and nivolumab in patients with advanced melanoma. Presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA9519), the results of this trial concluded that the addition of the vaccine did not improve progression-free survival.
“Longer follow-up is required for the accurate assessment of overall survival,” suggested the investigators. “No significant toxicity increases were observed with the addition of UV1. Data from a biomarker-driven cohort are awaited.”
This open-label, multicenter, phase II study enrolled 156 patients with unresectable or metastatic, stage IIIB to IIID melanoma who did not receive prior anticancer therapy (ClinicalTrials.gov identifier NCT04382664). Participants were randomly assigned 1:1 to receive 3 mg/kg of ipilimumab plus 1 mg/kg of nivolumab, followed by 480 mg of nivolumab maintenance therapy, with or without eight 300-mg intradermal UV1 injections (n = 78 each). Endpoints included progression-free survival, safety, objective response rate, duration of response, and overall survival.
The minimum follow-up was 18 months. The median patient age was 60, and 48% of patients had stage M1c or M1d disease. Approximately 42% of participants were positive for BRAF mutations, and 38% had a high lactate dehydrogenase level. The progression-free survival rate at 12 months was 57% in both treatment arms. Similarly, the 12-month overall survival rate was 87% among patients who received UV1 and 88% among those who did not; objective response rates were 60% and 59%, respectively. Of note, the incidence of grade 3 and higher adverse events was comparable between the treatment groups.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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