NSCLC: Transgene launches cancer combo tests

In the pilot study, 33 patients with metastatic non-squamous NSCSLC retractive to first-line standard therapy (platinum-based chemotherapy) will be enrolled at UC Davis to determine the overall response rate as a measure to estimate superiority of the combo over Opdivo monotherapy. Readout is expected to be available at the end of 2017. Secondary endpoints include progression-free survival and overall survival. Karen Kelly, MD, a world-renowned expert of lung cancer and Associate Director for Clinical Research at UC Davis Comprehensive Cancer Center (USA, California), is the Principal Investigator of this Phase II study.

According to  Transgene’s pipeline, the company also expects readout of a study investigating the same combo as first-line therapy at the end of the year. TG4010 is a therapeutic cancer vaccine in which a modified vaccinia Ankara expression vector produces the tumour-associated antigen MUC1 and the cytokine interleukin 2. In a proof-of concept study, published in Lancet, a TG4010/platinum-based chemotherapy combo showed  efficacy as measured by progression-free survival vs chemo monotherapy in a biomarker-selected NSCLC subpopulation without known activating EGFR mutations. Opdivo is approved in the USA for the 2^nd line treatment of advanced non-small cell lung cancer.

The TG4010/Opdivo 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. Bristol-Myers Squibb is supplying Opdivo.

In 2014, Novartis did not exercise an option to licence TG4010 following announcement of the first of two Phase IIb trials conducted with the compound + chemotherapy.