REAL-WORLD PATIENT CASE STUDIES
Advancing clinical insight through biomarker-driven navigation
Real, anonymized Navexio patient cases illustrating how a structured, biomarker-driven approach can inform clinical decision-making, particularly in complex or refractory settings where standard options have been exhausted or where additional diagnostic clarity is required.
Case 1 - Metastatic Triple-negative breast cancer (TNBC)
Identification of FGFR2 Amplification Informs Biomarker-Guided Clinical Trial Opportunities in Advanced TNBC
Patient: 63 y/o female
Key Finding: FGFR2 amplification
Gap: No prior biomarker testing
Clinical Background
A 63-year-old patient was diagnosed with metastatic triple-negative breast cancer (TNBC) in May 2022 with progression across multiple lines of therapy, including chemotherapy, immunotherapy, and antibody-drug conjugates. Despite receiving standard and later-line treatments (including sacituzumab govitecan and eribulin), the disease continued to progress with metastases to liver, lymph nodes, peritoneum, and bone. The patient had begun exploring alternative approaches, including international immunotherapy, with limited clinical benefit.
Navexio Navigation
Navexio discovered that no biomarker testing had been performed and worked with the patient and her cancer care team to conduct comprehensive diagnostic navigation, including advanced molecular profiling to identify actionable biomarkers. This led to the identification of an FGFR2 amplification, alongside additional molecular insights. Navexio then supported clinical trial and drug access navigation to develop a strategy to access an FGFR2-targeted therapy, aligning a treatment plan with the tumor's molecular drivers.
Outcome: Navexio's navigation enabled a transition from non-targeted therapies to a biomarker-driven treatment strategy, opening access to a targeted therapy aligned with tumor biology and providing a new therapeutic pathway where prior standard options had been exhausted.
Case 2 - Metastatic cholangiocarcinoma
Identification of Targeted Therapy Options Through Molecular Profiling in Cholangiocarcinoma
Patient: 76 y/o female
Key Finding: KRAS and PTEN mutations
Gap: No prior biomarker-driven strategy
Clinical Background
A 76-year-old patient with metastatic cholangiocarcinoma received first-line cisplatin-gemcitabine plus durvalumab, consistent with standard of care. Despite treatment, options beyond first-line therapy remained unclear, and no biomarker-driven strategy had been established.
Navexio Navigation
Navexio supported the patient and HCP with accessing advanced diagnostic navigation, uncovering KRAS and PTEN mutations, which were not previously leveraged for treatment planning. Navexio then conducted clinical trial and drug access navigation to identify investigational therapies targeting pan-KRAS and PTEN pathways, and supported evaluation of eligibility and access pathways.
Outcome: Navexio enabled the identification of novel targeted therapy opportunities and clinical trials, expanding treatment options beyond standard chemotherapy and immunotherapy and aligning care with the patient's molecular profile.
Case 3 - Stage IV GEJ adenocarcinoma
Resolving HER2 Status to Inform Targeted Treatment Strategy in Metastatic GEJ Cancer
Patient: 75 y/o male
Key Finding: HER2 overexpression (IHC 3+)
Gap: Inconclusive prior assays
Clinical Background
A 75-year-old patient was diagnosed with stage IV gastroesophageal junction (GEJ) adenocarcinoma with metastases to liver and lung. Initial molecular testing from hospital-based assays was inconclusive or unreliable due to poor sample quality, and HER2 status remained uncertain (equivocal IHC and negative FISH). The patient had received systemic therapy and radiation but lacked clear biomarker-guided direction for subsequent treatment.
Navexio Navigation
Navexio coordinated comprehensive molecular re-testing using both tissue and liquid biopsy approaches, improving diagnostic accuracy and overcoming prior sample limitations. This revealed HER2 overexpression (IHC 3+) and RNA overexpression (ERBB2/ERBB3). Navexio provided evidence-based interpretation and guidance to the care team, supporting HER2-targeted treatment strategies and outlining sequencing options, including trastuzumab and trastuzumab deruxtecan (Enhertu).
Outcome: The patient's treatment plan shifted to HER2-targeted therapy, resulting in a more personalized and biologically aligned approach. This represented a significant change from prior non-targeted therapy and enabled access to therapies associated with improved response rates in HER2-positive disease.