Receives FDA IND Approval to begin a clinical trial with TG4010 + Nivolumab + Chemotherapy in the first-line treatment of Lung Cancer (NSCLC)
Announces that the US Food and Drug Administration (FDA) has granted Transgene Investigational New Drug (IND) clearance to proceed with a Phase 2 clinical trial of TG4010 in combination with Opdivo (nivolumab) and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in the USA.The Phase 2 clinical trial will explore the potential of combining Transgene’s TG4010, an investigational therapeutic vaccine, in association with Bristol-Myers Squibb’s immune checkpoint inhibitor, nivolumab, which acts by overcoming immune suppression. Both therapies will be combined with standard chemotherapy in first-line NSCLC patients, whose tumors express low and undetectable levels of PD-L1.Transgene is the sponsor of this international trial. Transgene has signed a clinical collaboration agreement with Bristol-Myers Squibb, which will provide nivolumab for the study (see press release dated April 25, 2017).
The Phase 2 trial will evaluate objective tumor responses and disease control. The study will also assess the safety and tolerability of the regimen together with other efficacy parameters. This multi-center single-arm trial will enroll patients both in the USA and Europe.
The first patient is expected to be included into this Phase 2 study at the end of 2017.