August 17, 2020 – Thermo Fisher Scientific signed a companion diagnostic (CDx) agreement with Hengrui Therapeutics, Inc. (HTI), a U.S. subsidiary of Chinese pharmaceutical company Jiangsu Hengrui Medicine Co., Ltd. (JHM), to develop a CDx that will leverage the Oncomine Precision Assay, which runs on the new Ion Torrent Genexus System. Once commercialized, the CDx will be used to identify non-small cell lung cancer (NSCLC) patients who may be eligible for pyrotinib, JHM’s novel, irreversible pan-HER2 tyrosine kinase inhibitor.
Under the terms of the agreement, Thermo Fisher will retain rights to commercialize the test globally and will seek approval from regulatory agencies. The company has previously announced a CDx agreement that also leverages the Oncomine Precision Assay for the Genexus System. In June the FDA granted the assay Breakthrough Device Designation to identify isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations in low-grade glioma patients.
HER2 mutations are present in about 4% of patients with NSCLC, yet there is currently no targeted therapy approved by the U.S. Food & Drug Administration (FDA) for patients with HER2-mutated NSCLC. HTI recently released results from a phase 2 clinical trial demonstrating that pyrotinib showed promising antitumor activity in patients with HER2-mutant advanced NSCLC who were previously treated with chemotherapy.
The drug received conditional approval in China for the treatment of HER2-positive, advanced or metastatic breast cancer in chemotherapy-treated patients in 2018 based on positive phase 2 clinical trial results and full approval in 2020 based on two successful phase 3 studies. HTI’s global clinical trial program for pyrotinib is currently in phase 3 clinical trials, with studies underway in China, Europe and the U.S.