Policy & Regulation
UC Davis to Conduct Phase 2 Trial of the Combination Therapy in Metastatic Non-Small Cell Lung Cancer
8 December 2016 - - French immunotherapies company Transgene (PAR: TNG) has signed a collaborative arrangement with UC Davis (USA, California) 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), the company said.

This trial is supported by Transgene through financial support and supply of TG4010 and by Bristol-Myers Squibb through supply of nivolumab for use in the clinical study.

Karen Kelly, MD, a world-renowned expert of lung cancer and Associate director for Clinical Research at UC Davis Comprehensive Cancer Center, is the Principal Investigator of this Phase 2 study.

The enrollment of the first patients is expected in the coming weeks.

TG4010 is an active immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2.

TG4010, which is based on a modified vaccinia virus, induces an immune response against MUC1 expressing tumors, such as non-squamous NSCLC.

Its mechanism of action and excellent safety profile make TG4010 a very suitable candidate for combinations with other therapies, such as Opdivo, a PD-1 immune checkpoint inhibitor that is designed to prevent the PD-1 pathway from suppressing the immune system's response against tumors.

Opdivo is approved in the USA for the 2nd line treatment of advanced non-small cell lung cancer.

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, overall survival, duration of response and safety.

Immunotherapy, particularly the use of immune checkpoint blockers such as the anti-PD-1 Opdivo, is rapidly transforming cancer care, due to its demonstrated antitumor activity.

There is increasing interest among the medical community in exploring whether combining different immunotherapy agents could provide additional benefit to patients.

This study will evaluate the efficacy of this combination of immunotherapies that target distinct stages of the immune cycle.
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