Guardant Health is set to redefine personalised cancer care, partnering with Boehringer Ingelheim to advance FDA approval of the Guardant360 CDx liquid biopsy. This innovative diagnostic tool could soon play a pivotal role in identifying patients with HER2 mutations, supporting the targeted application of Boehringer’s investigational drug zongertinib for non–small-cell lung cancer (NSCLC).
Boehringer Ingelheim’s zongertinib represents a promising addition to the treatment landscape for advanced NSCLC, targeting activating HER2 mutations. Although the drug is still undergoing FDA review, the Phase Ib Beamion LUNG-1 trial has showcased its potential, achieving a compelling 66.7% objective response rate in patients with heavily pre-treated advanced NSCLC. The trial also highlighted the drug’s tolerability, paving the way for its integration into precision oncology.
Guardant360 CDx could become a game-changer upon zongertinib’s approval, offering a non-invasive method to pinpoint eligible patients using advanced tumour genomic profiling from a simple blood draw. This approach is particularly critical for patients unresponsive to conventional therapies like chemotherapy or immunotherapy, expanding their options with targeted, effective solutions.
Recent large-scale research published in Nature Medicine further underscores the impact of Guardant360 CDx, showing that liquid biopsy-guided treatment can significantly extend survival. Patients matched with therapies based on Guardant360 CDx results lived twice as long as those who did not benefit from such personalised diagnostics, spotlighting the paradigm shift in cancer care enabled by this technology.
With its track record of success, the Guardant360 CDx liquid biopsy has already earned FDA approval as a companion diagnostic for multiple cancer treatments, including four for NSCLC and one for breast cancer. Now, its potential role in Boehringer Ingelheim’s late-stage pipeline could herald a new era for NSCLC patients, where personalised therapy becomes the standard, not the exception.
Guardant Health continues to lead innovation in cancer diagnostics, developing advanced tools that empower tailored treatment strategies and improve patient outcomes.
EDX Medical Group Plc (AQSE:EDX) is a global specialist in digital clinical diagnostics; developing and supporting high-performance products and services to provide cost-effective prediction of disease risk, inform clinical decision-making, enable personalised healthcare and accelerate the development of new medicines for cancer, neurology, heart disease and infectious diseases.
