French biotechnology company Transgene has begun dosing patients in a Phase II trial of TG4010 in combination with Bristol-Myers Squibb's Opdivo (nivolumab) to treat metastatic non-small-cell lung cancer (NSCLC).

Based on a modified vaccinia virus (MVA), TG4010 is an active immunotherapy designed to express the coding sequences of the MUC1 tumour-associated antigen and the cytokine Interleukin-2 (IL2).

Opdivo is a PD-1 immune checkpoint inhibitor that prevents the PD-1 pathway from suppressing the immune response against tumours.

With plans to enrol approximately 33 patients, the multi-centre Phase II trial will evaluate the TG4010 and Opdivo combination as a second line treatment after failure of one line of platinum-based chemotherapy.

"Today, advanced lung cancer remains a severe disease with a poor prognosis. Major improvements are needed in the therapeutic options available to physicians."

Transgene chief medical officer Maud Brandely said: "We are convinced that the complementary mechanisms of action of TG4010 and Opdivo can enhance response rates, increase the duration of response and extend overall survival in patients.

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"Today, advanced lung cancer remains a severe disease with a poor prognosis. Major improvements are needed in the therapeutic options available to physicians.”

The trial is being conducted in collaboration with US-based UC Davis Comprehensive Cancer Center, and its primary objective is to assess the overall response rate of the combination in stage IV non-squamous NSCLC patients who have progressed after one line of platinum-based chemotherapy.

The trial will also examine secondary endpoints such as progression-free survival (PFS), overall survival (OS), duration of response and safety.

It is expected that the trial's first results will be reported by the end of this year.