Transgene: FDA gives green light to Phase II trial with TG4010 targeted immunotherapy in lung cancer
Transgene announced that it recently met with the U.S. food and Drug Administration (FDA) for an end of Phase II meeting when results of its TG4010 controlled phase IIb clinical trial in non-small-cell lung cancer (NSCLC) were reviewed. As per the minutes of the meeting, the FDA agrees with the proposal to proceed as planned to a phase III study in combination with first line chemotherapy in patients with advanced NSCLC and with a normal level of activated Natural Killer (NK) cells before treatment.
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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