KEY TAKEAWAYS
- The LUNGVAC phase II trial aimed to assess efficacy and safety of anti-PD-1 treatment ± UV1 vaccination in treatment-naïve, advanced NSCLC patients.
- The primary endpoint is PFS and the trial is ongoing.
First-line treatment for patients with stage IIIB/C and IV non small cell lung cancer (NSCLC), who lack EGFR mutation or ALK translocation and exhibit PD-L1 expression of 50% or higher, typically involves monotherapy with Programmed Death Ligand 1 (PD1) inhibitors. However, despite this regimen, fewer than 50% of these patients respond to Immune Checkpoint Inhibitor (ICI) treatment, highlighting the imperative to enhance the proportion of patients deriving benefit from ICI therapy.
UV1, a peptide-based cancer vaccine targeting hTERT, stimulates CD4 T cell expansion against UV1 peptides, initiating an anti-tumor immune response. Its combination with ICI leverages synergistic potential by blocking inhibitory signals, enhancing vaccine-induced T cell expansion and anti-tumor effector activity.
Elin Marie Stensland and the team aimed to conduct a randomized phase II, open-label, multicenter study to assess the efficacy and safety of anti-PD-1 treatment, with or without UV1 vaccination, in treatment-naïve patients diagnosed with advanced or metastatic NSCLC and exhibiting PD-L1 expression of 50% or higher.
The main eligibility criteria include presence of at least one measurable lesion per Recist 1.1, sufficient organ function, ECOG performance status ranging from 0 to 2, and absence of other active cancers. Stratification factors encompass squamous versus non-squamous histology and ECOG performance status categorized as 2 versus 0 or 1. The primary endpoint is progression-free survival (PFS).
To achieve 80% power and a one-sided alpha level of 0.10 for testing the PFS null hypothesis, 97 PFS events are required. Based on the published data from KEYNOTE-024 on pembrolizumab monotherapy, a total of 138 patients will be randomized 1:1 to receive PD-1 inhibitor treatment with or without 8 injections of the UV1 vaccine over the initial 2 months, aiming to generate the necessary 97 PFS events.
The enrollment period is anticipated to span 18 months, followed by a minimum follow-up duration of 18 months. As of September 2023, 20 patients have been enrolled. Results will be updated as the study progresses. Research is funded by Vestre Viken Hospital Trust.
Source: https://cslide.ctimeetingtech.com/immuno2023/attendee/confcal/show/session/35
Clinical Trial: https://clinicaltrials.gov/study/NCT05344209
Stensland EM et al.(2023) ‘’The LUNGVAC-study; A randomized phase II, open-label, multicenter study investigating efficacy and safety of anti-PD-1/PD-L1 treatment +/- UV1 vaccination as first line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer (NSCLC).’’ Presented at ESMO IO 2023 (156TiP).
