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.
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.
"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.