The US Food and Drug Administration (FDA) has granted accelerated approval to HERNEXEOS (zongertinib)-a HER2 selective tyrosine kinase inhibitor- for adults with previously treated, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain activating mutations. Simultaneously, the FDA approved Thermo Fisher’s Oncomine Dx Target Test as the companion diagnostic (CDx) to identify patients eligible for HERNEXEOS. These approvals mark a significant advancement in the personalization of lung cancer treatment, says GlobalData, a leading data and analytics company.

The decision was based on results from the Beamion LUNG-1 phase 1b trial. In a cohort of 71 patients previously treated with platinum-based chemotherapy, the objective response rate was 75%, and 58% of these patients had a duration of response lasting at least 6 months. The Oncomine Dx Target Test is now validated to detect HER2-TKD activating mutations in NSCLC and serves as a critical tool to identify patients who are candidates for zongetinib treatment. The CDx proves to be an essential part of the treatment.

Alexandra Murdoch, Senior Medical Analyst at GlobalData, comments: “Thermo Fisher’s Oncomine Dx Target Test has been a pioneer in NGS-based CDx platforms, with the first approval for screening for multiple NSCLC therapies in 2017. The current addition of HER2-TKD mutation detection further broadens the panel’s utility in targeted therapy selection.”

By evaluating multiple actionable biomarkers in a single test, NGS-based CDx eliminates the delays of sequential assays, which is crucial in fast-progressing cancers like NSCLC. Thermo Fisher’s ongoing partnerships with pharmaceutical companies streamline the co-development and simultaneous approval of drugs and their CDx, enhancing treatment rollout efficiency.

Thermo Fisher’s Oncomine Dx Target Test is not the only CDx on the market, but a vast majority of the approved CDx are for oncology. A recent GlobalData report, Companion Diagnostics, shows that both pipeline and marketed CDx products have cancer as the top indication. Furthermore, GlobalData expects the oncology diagnostics market to grow significantly, from $1.9 billion in 2022 to over $3.1 billion in 2030.

Murdoch adds: “CDx are a crucial part of treatment for many patients. The ability to determine eligibility for targeted therapies, especially in oncology, can improve treatment significantly.”

Murdoch concludes: “By pairing a highly targeted HER2-TKD therapy with a NGS-based CDx, healthcare professionals can more rapidly and accurately identify eligible patients, helping to deliver effective treatment. As technologies like the Oncomine platform continue to evolve, the integration of precision testing with innovative therapies promises to bring the benefits of precision medicine to more patients.”