Transgene has completed patient enrolment in a Phase II clinical trial of TG4010 in combination with Bristol-Myers Squibb ’s Opdivo (nivolumab) plus chemotherapy to treat advanced non-squamous, non-small cell lung cancer (NSCLC).
The trial recruited a total of 39 patients with low or no programmed death-ligand 1 (PD-L1) expression in tumour cells.
TG4010 is an investigational active immunotherapy designed to act against Mucin 1 (MUC1) tumour-associated antigen, while Opdivo is an immune checkpoint inhibitor.
Being conducted in the US and Europe, the single-arm Phase II trial is designed to assess TG4010, Opdivo and standard platinum doublet chemotherapy combination as a first-line therapy.
The primary endpoint of the study is objective response rate (ORR), while the safety, tolerability, efficacy and immunological parameters of the combination will be tracked.
The trial’s secondary outcome measures include progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and duration of overall response (DoR).
Transgene chief medical officer Maud Brandely said: “We are looking forward to reporting the first efficacy data of our active immunotherapy TG4010, with nivolumab and chemotherapy as a first-line treatment of advanced lung cancer for patients whose tumours express low or undetectable levels of PD-L1.
“Today anti-PD-1 therapy is relatively less effective in this large subset of NSCLC patients. With this triple combination regimen, we aim to significantly improve treatment outcomes in this major oncology indication.”
Transgene noted that the primary endpoint data collected from at least 35 evaluable subjects will be reported in Q4 2019.
Results from a previous Phase IIb trial in patients with advanced non-squamous NSCLC showed increased response rate, PFS and OS with TG4010 immunotherapy plus chemotherapy as first-line treatment.