OSE Immunotherapeutics ((DE:6OP)), DEL_OSE Immunotherapeutics ((DEL_0RAD)) announced an update on their ongoing clinical study.
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Study Overview: The clinical study titled A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor aims to evaluate the effectiveness and safety of the therapeutic cancer vaccine OSE2101 in patients with NSCLC who have developed resistance to immune checkpoint inhibitors. This study is significant as it targets a challenging aspect of cancer treatment, potentially offering a new therapeutic option for patients with limited alternatives.
Intervention/Treatment: The study tests OSE2101, a peptidic cancer vaccine designed to target specific tumor-associated antigens, administered via subcutaneous injection. The control group receives Docetaxel, a standard chemotherapy drug given through intravenous infusion.
Study Design: This is a randomized, open-label, phase 3 trial with a parallel intervention model. Participants are randomly assigned to either the experimental group receiving OSE2101 or the control group receiving Docetaxel. The primary purpose of the study is treatment-focused, with no masking involved.
Study Timeline: The study began on December 3, 2024, with the primary completion and estimated completion dates yet to be determined. The latest update was submitted on June 30, 2025, indicating ongoing recruitment and study progress.
Market Implications: The progress of this study could significantly impact OSE Immunotherapeutics’ stock performance, as successful results may enhance investor confidence and market position. The study’s outcome could also influence the competitive landscape in the NSCLC treatment market, particularly concerning companies focusing on cancer vaccines and immunotherapies.
The study is currently ongoing, with further details available on the ClinicalTrials portal.