Transgene: FDA gives green light to Phase II trial with TG4010 targeted immunotherapy in lung cancer
Furthermore, Transgene presented additional TG4010 phase IIb data at the American Society of Clinical Oncology (ASCO) 2009 annual meeting in Orlando, on 31st May Florida confirming the previously reported positive results for TG4010.
The additional data for TG4010 now reflects 24 months of median follow up. It confirms a 6-month increase in median survival (17.1 months in the experimental arm versus 11.3 months in the control arm) in patients with normal levels of activated NK cells at baseline (some 75% of the patients in the trial), a sub-population identified by Transgene’s biomarker programme11The biomarker project is partly financed by an OSEO (French agency specialised in innovation & development funding) grant as part of the ADNA programme (Advanced Diagnostics for New Therapeutic Approaches).
All other relevant parameters (response rate, progression-free survival at 6 months, time to progression) confirmed an improved clinical outcome for patients of this sub-population treated with TG4010. The latest data therefore confirm the identification of activated NK cells as an appropriate predictive biomarker associated with positive clinical outcome of the treatment with TG4010 in NSCLC.
Moreover, post-treatment sample analysis after six TG4010 injections showed a longer median survival for those patients treated with TG4010 and chemotherapy who had an increased level of activated T lymphocytes (p = 0.026), supporting the expected mechanism of action of the targeted immunotherapeutic product.
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Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.
Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.