- The clinical trial comes in collaboration with U.S pharma firm Bristol-Myers Squibb.
- The study’s primary endpoint is expected in Q4 2019.
French biopharmaceutical firm, Transgene SA has recently announced that it has enrolled the last patient in its Phase 2 trial for evaluating TG4010 in conjunction with Opdivo® and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) with low or no expression of PD-L1 by the tumor cells.
As per sources, the company claims that the study’s primary endpoint on at least 35 evaluable patients will be reported in Q4 2019. While the trial will be conducted by Transgene under a clinical collaboration agreement with U.S. based pharmaceutical firm Bristol-Myers Squibb Co., which is supplying its immune checkpoint inhibitor, Opdivo®(nivolumab).
Reports cite that the Phase 2 clinical trial is investigating the efficacy and tolerability of the combination treatment of Transgene’s TG4010, a trial active immunotherapy opposed to tumor-associated MUC1 antigen, with Opdivo® which is designed to overcome immune suppression as well as standard platinum-based doublet chemotherapy.
Moreover, the single-arm, multi-center trial has enrolled patients both in Europe and the U.S. Whereas the study will further assess the tolerability and safety of the regimen together with other efficacy and immunological parameters.
According to a statement, Maud Brandely, CMO, Transgene, said that the company is looking forward on recording the first efficacy data of their active immunotherapy TG4010, with chemotherapy and nivolumab as a first-line treatment of advanced lung cancer for patients whose tumors express low or undetectable levels of PD-L1.
She claims that today’s anti-PD-1 therapy is relatively less effective in a large subset of NSCLC patients. However, with this triple combination regimen, the company aims to significantly improve treatment outcomes in this major oncology indication.
Reliable sources cite that the TG4010 immunotherapy in combination with chemotherapy has confirmed significant efficacy in terms of improved response rate, progression-free survival and overall survival in a double-blind, randomized, placebo-controlled Phase 2b trial in first-line treatment of patients with advanced non-squamous NSCLC.