Hengrui Signed Agreement with Thermo Fisher Scientific on Companion Diagnostic to identify NSCLC patients for Pyrotinib treatment
July 24, 2020
July 24, 2020
Hengrui Therapeutics, Inc. (HTI) a US subsidiary of Jiangsu Hengrui Medicine (JHM) signed a companion diagnostic (CDx) agreement with Thermo Fisher Scientific to develop a CDx that will leverage the Oncomine Precision Assay to identify non-small cell lung cancer (NSCLC) patients who may be eligible for pyrotinib, JHM’s novel, irreversible pan-HER2 tyrosine kinase inhibitor.
HER2 mutations are present in about 4 percent 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. JHM and HTI recently released results from two early phase clinical trials conducted in both China and US, respectively, the results demonstrated 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 phase 3 studies. Hengrui’s global clinical trial program for pyrotinib is currently in phase 3 clinical trials, with studies underway in China, the United States and Europe.
“An approved targeted therapy for patients with HER2-mutated non-small cell lung cancer could save thousands of lives,” said Dr. Lianshan Zhang, R&D President of JHM. “We are excited to partner with Thermo Fisher on a companion diagnostic that 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.”
HER2 mutations are present in about 4 percent 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. JHM and HTI recently released results from two early phase clinical trials conducted in both China and US, respectively, the results demonstrated 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 phase 3 studies. Hengrui’s global clinical trial program for pyrotinib is currently in phase 3 clinical trials, with studies underway in China, the United States and Europe.
“An approved targeted therapy for patients with HER2-mutated non-small cell lung cancer could save thousands of lives,” said Dr. Lianshan Zhang, R&D President of JHM. “We are excited to partner with Thermo Fisher on a companion diagnostic that 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.”
