Thermo Fisher Scientific and Daiichi Sankyo have expanded their partnership by signing a new agreement to co-develop a companion diagnostic (CDx) that will utilize Thermo Fisher’snext-generation sequencing (NGS)-based Oncomine Dx Target Test. The CDx will be designed to identify non-small cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who may be eligible for Enhertu, a HER2 directed antibody drug conjugate (ADC), which is currently in global phase 2 development for HER2 mutated or HER2 overexpressing NSCLC.
Enhertu has demonstrated a strong response rate in patients with HER2 positive metastatic breast cancer and preliminary results show a similar response in patients with metastatic NSCLC with HER2 mutations.1-2 HER2 mutations have long been implicated in breast cancers, but they are considered a rare event in NSCLC. Recent studies have found that HER2 mutations are the key drivers in about 1-3 percent of NSCLC cases.Under the terms of the agreement, Thermo Fisher will retain rights to commercialize the test globally and will seek approval from regulatory agencies. The announcement follows a 2018 agreement between the companies to expand the clinical utility of the test in support of clinical trials and drug development programs at Daiichi Sankyo.
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