OSE Immunotherapeutics: One2Treat Voice for outcomes prioritization in ARTEMIA

Background

ARTEMIA is a phase III trial comparing OSE2101, a cancer vaccine, to docetaxel in HLA-A2-positive patients with metastatic NSCLC and secondary resistance to Immune Checkpoint Inhibitor (ICI), with overall survival (OS) as primary endpoint. To consider additional outcomes in a single analysis, an exploratory endpoint estimating the Net Treatment Benefit (NTB) of OSE2101 versus docetaxel is planned. Hereby we report the preferred outcomes and their priority order appraised by the investigators for the NTB analysis.

Methods

The elicitation software One2Treat Voice captured which outcomes were prioritized by the investigators, their relative importance and meaningful thresholds. Investigator could choose up to 5 out of 7 outcomes selected from the study’s main endpoints: OS, Progression-Free survival (PFS), QLQ-C30 Global Quality of Life (QoL), physical QoL, role QoL, side-effect burden QoL, and serious adverse events (SAEs) occurrence. The software used an adaptive algorithm to present simulated pairs, distinguishing between two treatments without disclosing investigational products. For each pair, investigators selected which patient had the better overall situation. Preferences were inferred and aggregated to inform the design of the NTB analysis. Participation was voluntary and anonymized.

Results

From March 17 to 24, 2025, investigators (N=29) completed the questionnaire in an average of 9 minutes [min: 4, max: 24]. Five outcomes were selected by investigators, with overall survival (OS) preferred by 72% of investigators, followed by Global QoL, PFS, side effects burden, and SAEs. The corresponding thresholds were 3 months for OS, 6 months for PFS, and 1-level improvement for QoL and side effects.

Conclusions

The One2Treat Voice software enabled rapid collection of investigator preferences in the OSE ARTEMIA trial for relevant outcomes, their prioritization, and the corresponding thresholds. This approach ensures that the planned Net Treatment Benefit analysis is fully aligned with clinical practice and actively involves investigators in the trial design process.