Clinical Trials

Date: 2017-03-03

Type of information: Treatment of the first patient

phase: 2

Announcement: treatment of the first patient

Company: University of California, Davis, (USA - CA) Transgene (France) BMS (USA - NY)

Product: TG4010 and Opdivo® (nivolumab)

Action mechanism:

immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. TG4010, a novel immunotherapy targeting the MUC1 protein, is being developed for the treatment of metastatic non-small cell lung cancer. TG4010 is a therapeutic vaccine expressing the MUC1 antigen and Interleukin-2 (IL2), a cytokine that stimulates the immune system. The MUC1 protein is normally found on the surface of certain cells in many tissue types. In tumor cells, several modifications of MUC1 can occur which distinguish it from MUC1 in normal cells. These changes transform the MUC1 protein into a highly immunogenic tumor associated antigen (TAA) and make it an attractive target for cancer immunotherapy. TG4010 is designed to help the body’s immune system identify cancerous cells carrying the MUC1 TAA as a target to be destroyed. In addition to lung cancer, the MUC1 TAA is expressed in other solid tumor types, including breast, colorectal, kidney and prostate cancers.
Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.

Disease: metastatic non-small-cell lung cancer (NSCLC)

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

This multi-center Phase 2 trial will evaluate the efficacy (overall response rate) of the TG4010 plus Opdivo® regimen in patients with stage IV non-squamous non-small cell lung cancer who have progressed after one line of platinum-based chemotherapy. Secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response and safety.
The trial is being conducted via a collaborative arrangement with UC Davis. The investigator-initiated study led by UC Davis Medical Center is financially supported by Transgene. BMS is supplying Opdivo®.
Karen Kelly, MD, Associate Director for Clinical Research at UC Davis Comprehensive Cancer Center (USA, California), is the Principal Investigator of this Phase 2 study.(NCT02823990)

Latest news:

• On March 13, 2017, Transgene announced the dosing of the first patient of the Phase 2 trial evaluating TG4010 in combination with Opdivo® (nivolumab) for the treatment of metastatic non-small cell lung cancer after failure of one line of platinum-based chemotherapy. The trial will enroll up to 33 patients. First results could be expected from the end of 2017. • On December 7, 2016, Transgene announced the signature of a collaborative arrangement with UC Davis to support an investigator-initiated study led UC Davis Medical Center that will evaluate TG4010 in combination with Opdivo® (nivolumab) for the treatment of 2nd line metastatic non-small cell lung cancer (NSCLC). This trial is supported by Transgene through financial support and supply of TG4010 and by BMS through supply of nivolumab for use in the clinical study. This study is a Phase 2, multi-center, single arm, open-label trial. Its primary objective is to evaluate the efficacy (Overall Response Rate) of the combination of TG4010 plus Opdivo® in patients with stage IV non-squamous NSCLC who have progressed after one line of platinum-based chemotherapy. Secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response and safety.