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Thermo Fisher Scientific, Hengrui Therapeutics Ink CDx Deal for Pyrotinib in HER2-Mutated NSCLC

NEW YORK – Hengrui Therapeutics and Thermo Fisher Scientific announced on Monday an agreement to advance a companion diagnostic for identifying lung cancer patients with HER2 mutations who are eligible to receive Jiangsu Hengrui Medicine's treatment pyrotinib.

The companion diagnostic will be part of Thermo Fisher's Oncomine Precision Assay, which runs on the Ion Torrent Genexus System and can detect more than 50 cancer biomarkers in formalin-fixed, paraffin-embedded tumor samples and liquid biopsy specimens. The system boasts a one day turnaround time and is current labeled for research use, according to a statement from Thermo Fisher.

Under the terms of the agreement, Thermo Fisher will retain the rights to commercialize the companion test globally and seek regulatory approval. Lianshan Zhang, R&D president of Jiangsu Hengrui Medicine, said in a statement that a companion diagnostic "will make it easier for clinicians to identify patients who may benefit from pyrotinib, helping us broaden participation in clinical trials and make precision medicine available for more patients."

Hengrui Therapeutics, the US subsidiary of Chinese drug firm Jiangsu Hengrui Medicine, is developing the irreversible pan-HER2 tyrosine kinase inhibitor pyrotinib as a treatment for advanced non-small cell lung cancer patients with HER2 mutations. A Phase II trial has shown promising activity in HER2-mutant NSCLC patients previously treated with chemotherapy. HER2 mutations are present in around 4 percent of NSCLC cases, but there are no approved drugs for this subset of patients.

Pyrotinib garnered approval in China earlier this year for the treatment of HER2-positive, advanced or metastatic breast cancer based on data from two Phase III trials. The company has several Phase III studies underway involving this drug in Europe, US, and China.