Daiichi Sankyo has announced that it will not proceed with the second part of its phase 3 study for its lung cancer drug patritumab.
In a statement the company said that this decision followed the recommendation of an independent data monitoring committee (DMC) that concluded that the first part of the study did not meet the
pre-defined efficacy criteria required to proceed to the second part. There were no safety concerns identified by the DMC.
The HER3-Lung study is evaluating the investigational HER3 inhibitor patritumab, in combination with erlotinib, in patients with locally advanced or metastatic non-small cell lung cancer not selected for EGFR mutation but stratified by tumor expression of heregulin.
"We are disappointed that this study did not confirm the hypothesis that effective HER3 inhibition in combination with erlotinib would provide clinically relevant tumor growth control in subjects with
advanced non-small cell lung cancer," said Antoine Yver, executive vice president and global head, oncology research and development.
"This particular result does not directly affect the science of patritumab in other settings. The phase 2 study evaluating patritumab in head and neck cancer, in combination with cetuximab and a platinum agent, remains unchanged and ongoing."
The company added that data from the study will be presented at an upcoming scientific meeting, and that it will continue to examine the data to better understand the results and determine next steps for the development of patritumab in non-small cell lung cancer.