DEL_OSE Immunotherapeutics ((DEL_0RAD)), OSE Immunotherapeutics ((DE:6OP)) announced an update on their ongoing clinical study.
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OSE Immunotherapeutics has initiated a 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 efficacy and safety of the therapeutic cancer vaccine OSE2101 compared to the standard chemotherapy drug Docetaxel in patients with NSCLC who have developed resistance to immune checkpoint inhibitors. This research is significant as it explores new treatment avenues for a challenging 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 aims to enhance the immune response against cancer cells. The control group will receive Docetaxel, a well-established chemotherapy agent given through intravenous infusion.
The study employs a randomized, open-label design with a 2:1 allocation ratio, meaning more patients will receive OSE2101 than Docetaxel. The primary purpose is treatment, with no masking involved, allowing both researchers and participants to know which treatment is being administered.
The trial began on December 3, 2024, with the primary completion date yet to be announced. The latest update was submitted on July 28, 2025. These dates are crucial as they indicate the study’s progression and potential timelines for results.
This clinical update could positively impact OSE Immunotherapeutics’ stock performance as it progresses through the trial phases, potentially offering a new treatment option for NSCLC. Investors may view this development favorably, especially given the competitive landscape of cancer therapeutics, where innovation and successful trials can lead to significant market advantages.
The study is currently recruiting participants, and further details are available on the ClinicalTrials portal.