Background:
Patients with advanced head and neck squamous cell carcinoma (SCCHN) often lack access to standard systemic treatment options, particularly when residual toxicities from prior therapies preclude further standard-of-care regimens. This study evaluated the clinical utility, safety, and efficacy of Exacta multi-omics tumor profiling in guiding personalised therapeutic strategies for this patient population.
Methods:
A total of 31 patients (4 female, 27 male; median age 47 years, range 35–66) with metastatic, non-resectable, taxane-/platinum-refractory SCCHN were prospectively analysed. All patients had disease progression following 1–4 prior systemic therapies (median 2). Individualised treatment regimens were developed based on multi-omics profiling results integrating genomic, transcriptomic, proteomic, and metabolomic data. Treatment responses were assessed radiologically according to RECIST v1.1 criteria.
Results:
Personalised therapies were generally well tolerated. Grade III treatment-related adverse events (TRAEs) were observed in 8 patients, including oral mucositis, hypertension, anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, and fatigue. No Grade IV TRAEs or treatment-related deaths occurred. Radiologic evaluation demonstrated a partial response (PR) in 15 patients and stable disease (SD) in 14 patients, yielding an objective response rate (ORR) of 48.4% and a disease control rate (DCR) of 93.5%.
Conclusion:
Exacta multi-omics tumor profiling enabled the selection of tailored therapeutic regimens with a favorable safety profile and meaningful clinical benefit in heavily pretreated, refractory SCCHN patients. These findings support the integration of comprehensive multi-omics approaches into precision oncology workflows, potentially improving outcomes for patients with limited standard treatment options.