Phase 3 Study of Patritumab for NSCLC to be Discontinued
The two-part phase 3 HER-3-Lung study of patritumab for treatment of patients with non-small cell lung cancer will not proceed into the second part.
The 2-part phase 3 human epidermal growth factor 3 (HER3)-Lung study of patritumab for treatment of patients with non-small cell lung cancer (NSCLC) will not proceed into the second part, according to a news release.1
Led by Daiichi Sankyo Company, Limited in Tokyo, Japan, the HER3-Lung study was a global study that evaluated the investigational HER3 inhibitor patritumab in combination with erlotinib for treatment of patients with locally advanced or metastatic NSCLC.
The decision to not proceed was made by an independent data monitoring committee, which decided that the first part of the study did not meet the predefined efficacy criteria. The committee found no safety concerns.
“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 NSCLC,” said Antoine Yver, MD, MSc, executive vice president and global head of oncology research and development at Daiichi Sankyo.
Dr Yver noted, however, that the result of this trial “does not directly affect the science of patritumab in other settings.”
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He noted that a phase 2 study evaluating patritumab in combination with cetuximab and a platinum agent for treatment of head and neck cancer is ongoing.
Daiichi Sankyo has accepted the committee recommendation and will provide information regarding study discontinuation to health authorities and clinical investigators who participated in the HER3-Lung study.
- Daiichi Sankyo Provides Update on HER3-Lung Study of Patritumab in Non-Small Cell Lung Cancer (NSCLC) [news release]. Tokyo, Japan and Parsippany, New Jersey:PR Newswire. May 31, 2016. http://www.prnewswire.com/news-releases/daiichi-sankyo-provides-update-on-her3-lung-study-of-patritumab-in-non-small-cell-lung-cancer-nsclc-300276710.html. Accessed: May 31, 2016.