Bristol-Myers Squibb and Transgene have entered a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) + standard chemotherapy (CT) as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1.
The companies said that Phase 2 clinical trial will explore the potential of combining Transgene’s TG4010, an investigational therapeutic vaccine designed to generate an immune response against MUC1 expressing tumors such as NSCLC, in conjunction with Bristol-Myers Squibb’s immune checkpoint inhibitor, Opdivo, designed to alleviate immune suppression. Both therapies will be combined with standard chemotherapy in first line NSCLC patients, the companies explained. The Phase 2 trial will evaluate objective tumor responses, and disease control in patients provided the regimen of TG4010 + Opdivo + CT, whose tumors express low and undetectable levels of PD-L1. In addition, the study will evaluate safety and tolerability of this regimen together with other efficacy metrics. This multi-center single-arm trial is expected to deliver first results in 2018, the companies said.
According to the agreement, Transgene will be the sponsor of the trial. Bristol-Myers Squibb will provide Opdivo for use in the study.
“This trial will assess the potential of Transgene’s TG4010, an investigational therapeutic vaccine that is designed to stimulate the immune system, in combination with nivolumab, Bristol-Myers Squibb’s immune checkpoint inhibitor, and standard chemotherapy. Based on the results obtained with TG4010 in a large Phase 2b trial (TIME trial) in combination with chemotherapy, we are hopeful that this triple combination regimen could provide a treatment option for patients with advanced NSCLC,” commented Philippe Archinard, Chairman and CEO Transgene.