Strasbourg, France, December 23, 2015– Transgene SA (Euronext: TNG) today announced that the results from the Phase 2b part of the Phase 2b/3 TIME trial with TG4010 immunotherapy in non-small cell lung cancer (NSCLC) have been published in the peer-reviewed medical journal, The Lancet Oncology. The article, entitled “TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial,” by E. Quoix et al is now available online at
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00483-0/abstract.
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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