LUNGVAC is an investigator-initiated, randomized Phase II trial designed to assess the impact of UV1 in combination with the checkpoint inhibitor cemiplimab or pembrolizumab as first-line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer (NSCLC).

New treatment options available to NSCLC patients

The decision is driven by very slow recruitment in the study, which is primarily due to new treatment options available to NSCLC patients.  All 31 patients that have been enrolled in the LUNGVAC study since 2022 will be treated and followed up as per the trial protocol. Topline data from these patients is expected in the first half of 2025.

“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. 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,” says Carlos de Sousa, Chief Executive Officer at Ultimovacs. “We are grateful to the study investigators, their clinical teams and all patients who enrolled in the trial and we look forward to analyzing the topline data next year.”

An update before the end of 2024

Currently, Ultimovacs is investigating UV1 in ovarian cancer in the ongoing Phase II DOVACC trial which evaluates a combination of olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment of high-grade BRCA negative ovarian cancer. Patients continue to be screened and enrolled in this trial, and topline results are expected to be available in the first half of 2025. Additionally, Ultimovacs is conducting pre-clinical research on a novel drug conjugation platform to investigate its potential applicability, including additional therapeutic modalities for multiple disease areas, such as innovative drug conjugates with favorable pharmacological properties. Ultimovacs will provide an update on this technology platform to the market before the end of 2024.