NEW YORK ─ Oncology molecular diagnostics firm Genetron Health said on Thursday that it has signed a collaboration agreement with Hutchmed for the joint development of a companion diagnostic test in China for the pharma firm's Orpathys (savolitinib) lung cancer tyrosine kinase inhibitor.
Under the agreement, the partners plan to jointly validate and register Genetron Health’s NGS-based 8-gene Lung Cancer Assay (Tissue) as a CDx for Orpathys.
Financial and other terms of the agreement were not disclosed.
Weiguo Su, executive director and CSO of Hong Kong-based Hutchmed, said in a statement that a CDx test would be "a valuable tool for the use of Orpathys in the clinical setting for NSCLC patients harboring MET exon 14 skipping alterations."
The assay covers mutations of EGFR, BRAF, KRAS, HER2, and PIK3CA; translocations of ALK and ROS1; and MET exon 14 skipping. Seven of the genes are recommended as biomarkers by the 2018 National Comprehensive Cancer Network guideline for non-small cell lung cancer patients.
The test, which was approved by China’s National Medical Products Administration as an IVD assay in 2020 and obtained the CE mark in 2021, has been commercialized in China and is used in Chinese hospitals.
Orpathys is an oral MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations) or gene amplification. Following a priority review, Orpathys was granted drug registration conditional approval by the NMPA in China in June 2021.
Meanwhile, last November, Beijing-based Genetron announced it had entered a collaboration agreement with AstraZeneca R&D in China for the joint development of next-generation sequencing-based tumor-informed minimal residual disease tests for various solid tumor types, which the pharma firm will use in locally conducted drug studies.