Bristol-Myers Squibb Company and Transgene announced 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 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 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.
Under the terms of the agreement, Transgene will be the sponsor of the trial. Bristol-Myers Squibb will provide Opdivo for use in the study.
KPE’s Executive Program in Pharmaceutical Global Business
1000+ Case Studies, 100s of e-lectures, simulation based learning. Ideal for Top and Middle Level managers in Pharma and Bio-Pharma organization.
KPE-C-022 – KPE’s Certificate Program in Biologic (Biotech and Biosimilar) Regulation & Strategic
KPE-C-061 KPE’s Certificate course in Inlicensing and outlicensing in pharmaceutical industry