Ultimovacs ASA has announced the discontinuation of patient recruitment for the LUNGVAC trial, a Phase II study evaluating the UV1 cancer vaccine in combination with checkpoint inhibitors for the first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The decision, reached in agreement with the trial's investigators, was driven by slow patient enrollment due to the increasing availability of new treatment options for NSCLC.
The LUNGVAC trial (NCT05344209) is an investigator-initiated, randomized study designed to assess the impact of UV1 when combined with either cemiplimab or pembrolizumab in previously untreated patients with advanced or metastatic NSCLC whose tumors showed a PD-L1 expression score of 50% or higher. This patient subgroup represents approximately 30% of all advanced and metastatic NSCLC cases.
"We have consulted closely with the LUNGVAC investigators regarding the challenges in trial recruitment which relate to the evolution of standard of care for NSCLC patients and the resulting impact on the number of NSCLC patients eligible for the trial," said Carlos de Sousa, Chief Executive Officer at Ultimovacs. "Based on the investigators’ recommendations, recruitment will stop and the investigators will analyze the data on UV1 in this indication from the patients that have been enrolled so far."
Ongoing Analysis and Future Plans
All 31 patients enrolled in the LUNGVAC study since 2022 will continue to be treated and followed according to the trial protocol. Topline data from this cohort is anticipated in the first half of 2025. Ultimovacs is also currently investigating UV1 in the Phase II DOVACC trial for ovarian cancer, which assesses the combination of olaparib and durvalumab with or without UV1 as a second-line maintenance treatment for high-grade BRCA-negative ovarian cancer. Patient screening and enrollment are ongoing in the DOVACC trial, with topline results also expected in the first half of 2025.
About UV1
UV1 is a universal cancer vaccine designed to elicit a T cell response against telomerase, an antigen present in a majority of cancers. The vaccine comprises synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), which has been shown to induce CD4+ T cells. These CD4+ T cells can provide inflammatory signals and T cell support, critical for triggering a strong anti-tumor immune response. The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation, potentially enabling broad population utilization of the vaccine. UV1 is administered over three months as eight intradermal injections together with the immune-modulator, GM-CSF.
Ultimovacs' Broader Pipeline
In addition to its clinical programs, Ultimovacs is engaged in preclinical research on a novel drug conjugation platform. The company aims to provide an update on this technology platform before the end of 2024, exploring its potential applicability across multiple disease areas, including innovative drug conjugates with favorable pharmacological properties.
