Hengrui announced the initiation of a phase 3 pivotal clinical trial to evaluate the safety and efficacy of pyrotinib on HER2 exon 20 mutated NSCLC patients in the second-line settings.
November 19, 2019
November 19, 2019
Jiangsu Hengrui Medicine (JHM) and its US subsidiary Hengrui Therapeutics, Inc. (HTI) announced the initiation of a phase 3 pivotal clinical trial to evaluate the safety and efficacy of pyrotinib, an irreversible human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitor (TKI), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring a HER2 exon 20 mutation in the second-line setting.
HER2-mutated NSCLC is a subset of NSCLC in which the mutated human HER2 (erbB-2/neu) is an oncogenic driver. HER2 mutations have been reported in approximately 2% to 6% of NSCLC. There are currently no FDA approved targeted therapy for patients with HER2-mutated NSCLC. Several immune checkpoint inhibitors have been approved for non-selected NSCLC patients. However, data suggested that immune checkpoint inhibitors showed limited efficacy in the HER2-mutated NSCLC population. The initiation of this phase 3 study follows the End-of-Phase-2 meeting with the U.S. Food and Drug Administration (FDA).
About Pyrotinib
Pyrotinib is a novel, potent, irreversible, erythroblastic leukemia viral oncogene homolog (erbB) tyrosine kinase inhibitor (TKI) that blocks signal transduction through the HER2. The irreversible binding to this receptor results in sustained inhibition of these growth-promoting pathways. Pyrotinib was first approved in 2018 in China for HER2+ breast cancer. Pyrotinib has demonstrated acceptable safety and tolerability profiles, and treatment efficacy in a phase 1 (ongoing in the US) and phase 2 studies in China in HER2 mutant NSCLC patients.
HER2-mutated NSCLC is a subset of NSCLC in which the mutated human HER2 (erbB-2/neu) is an oncogenic driver. HER2 mutations have been reported in approximately 2% to 6% of NSCLC. There are currently no FDA approved targeted therapy for patients with HER2-mutated NSCLC. Several immune checkpoint inhibitors have been approved for non-selected NSCLC patients. However, data suggested that immune checkpoint inhibitors showed limited efficacy in the HER2-mutated NSCLC population. The initiation of this phase 3 study follows the End-of-Phase-2 meeting with the U.S. Food and Drug Administration (FDA).
About Pyrotinib
Pyrotinib is a novel, potent, irreversible, erythroblastic leukemia viral oncogene homolog (erbB) tyrosine kinase inhibitor (TKI) that blocks signal transduction through the HER2. The irreversible binding to this receptor results in sustained inhibition of these growth-promoting pathways. Pyrotinib was first approved in 2018 in China for HER2+ breast cancer. Pyrotinib has demonstrated acceptable safety and tolerability profiles, and treatment efficacy in a phase 1 (ongoing in the US) and phase 2 studies in China in HER2 mutant NSCLC patients.
