Thermo Fisher Scientific announced on Tuesday that it will expand the scope of it work with pharma Daiichi Sankyo via a new co-development agreement for a companion diagnostic (CDx) designed to identify non-small cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who may be eligible for the drug Enhertu.
The CDx development will be centered Thermo Fisher’s next-generation sequencing (NGS)-based Oncomine Dx Target Test.
“Our latest partnership with Daiichi Sankyo is focused on helping to solve an unmet medical need for a growing number of patients with HER2-mutated non-small cell lung cancer,” said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, in a press release. “This agreement underscores our continued commitment to working with global pharmaceutical partners to efficiently identify more patients who may benefit from the latest targeted therapies in their drug pipelines.”
Enhertu, a HER2 directed antibody drug conjugate (ADC), is currently in phase 2 clinical trials and has previously demonstrated a strong response rate in patients with HER2 positive metastatic breast cancer. Preliminary studies in NSCLC patients with HER2 mutations has shown similar response. HER2 mutations are the key drivers in about 1% to 3% percent of NSCLC cases, according to published research.
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.
The Oncomine Dx Target Test is the first targeted NGS in vitro diagnostic test approved by the U.S. Food and Drug Administration (FDA) for NSCLC. It is designed to evaluate multiple biomarkers associated with cancer and identify patients who are eligible for multiple FDA-approved targeted therapies using a single sample with results available in days.
Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
This indication is approved under accelerated approval based on tumor response rate and duration of response and continued approval for HER2-positive breast cancer may be contingent upon verification and description of clinical benefit in a confirmatory trial.