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OSE Immunotherapeutics Advances Phase 3 Trial for NSCLC Vaccine

DEL_OSE Immunotherapeutics ((DEL_0RAD)), OSE Immunotherapeutics ((DE:6OP)) announced an update on their ongoing clinical study.

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OSE Immunotherapeutics has announced an update on its Phase 3 clinical trial 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.’ The study aims to evaluate the effectiveness and safety of the therapeutic cancer vaccine OSE2101 in patients with NSCLC who have developed secondary resistance to immune checkpoint inhibitors. This trial is significant as it addresses the need for new treatment options in this patient population.

The intervention being tested is OSE2101, a peptidic cancer vaccine designed to target specific tumor-associated antigens. It is administered via subcutaneous injection and is intended to improve outcomes for patients with NSCLC. The control group receives Docetaxel, a standard chemotherapy drug.

The study follows a randomized, open-label design with parallel assignment. Participants are randomly allocated 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.

The study began on December 3, 2024, with the primary completion date yet to be announced. The last update was submitted on June 30, 2025. These dates are crucial for tracking the progress and expected timelines for results.

The update on this trial could influence OSE Immunotherapeutics’ stock performance positively, as successful outcomes may enhance investor confidence and market position. The competitive landscape in cancer therapeutics remains robust, with ongoing advancements by other companies in similar domains.

The study is currently recruiting, and further details can be found on the ClinicalTrials portal.

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