Navexio’s Real-World Patient Case Studies:

Advancing Clinical Insight Through Real-World Cases

The following selection of real, anonymized patient cases illustrate 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.

Enabling More Informed, Personalized Treatment Pathways

Across these cases, enhanced diagnostic insight and structured navigation contributed to more informed clinical decision-making and expanded treatment possibilities. Outcomes include:

  • Identification of clinically actionable biomarkers

  • Alignment of treatment strategies with tumor biology and molecular drivers

  • Discovery of biomarker-guided clinical trial opportunities

  • Improved confidence in shared decision-making between patients and care teams

While every patient journey is unique, these cases demonstrate how a precision oncology approach can help ensure that potential options are more fully explored and thoughtfully integrated into care planning.

Patient Case 1  – Identification of FGFR2 Amplification Informs Biomarker-Guided Clinical Trial Opportunities in Advanced TNBC

  • 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 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.

  • Navexio’s expert cancer navigation enabled a transition from non-targeted therapies to a biomarker-driven treatment strategy, opening access options to a targeted therapy aligned with tumor biology and providing a new therapeutic pathway where prior standard options had been exhausted.

Patient Case 2  – Identification of Targeted Therapy Options in Cholangiocarcinoma

  • 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 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.

  • 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.

Patient Case 3  – Resolving HER2 Status to Inform Targeted Treatment Strategy in Metastatic GEJ Cancer

  • 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 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).

  • 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.