The article discusses the results of this 222-patient randomized, double-blind, placebo-controlled study evaluating TG4010 in combination with first-line chemotherapy in Stage IV NSCLC patients. As previously reported, improvements were seen in progression-free survival, overall survival, response rate and duration of response in the TG4010 group compared to control, and these improvements were even more notable in patients with a “low” level of the triple positive activated lymphocytes (TrPAL ) biomarker, as well as in those patients with both low TrPAL and non-squamous disease. TG4010 was well tolerated, and the nature and incidence of adverse events in the TG4010 arm were consistent with previous Phase 2 clinical trials. The most frequent TG4010-related adverse events were mild to moderate injection site reactions.
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