Antonius Schuh, PhD, Trovagene.

In clinical data presented at the recent 2015 European Lung Cancer Conference, the urine-based Precision Cancer Monitoring (PCM) platform by Trovagene, San Diego, outperformed tissue biopsy for the detection and monitoring of EGFR T790M mutations in metastatic lung cancer patients.

The abstract, “Detection of EGFR T790M Mutation in Urinary Circulating Tumor DNA from Metastatic Non-Small Cell Lung Cancer Patients,” was presented by Hatim Husain, MD, assistant clinical professor of medicine at the University of California, San Diego.

In an interim analysis of 34 patients from an ongoing clinical study, Trovagene’s PCM platform detected the T790M mutation in all patients who were positive for the mutation in tissue biopsy. The company’s urine-based assay identified additional patients as T790M-positive, including those who had clinical suspicion of T790M-progressive disease, but were either negative by tissue biopsy or had not yet undergone tissue biopsy for confirmation. Trovagene’s PCM platform detected EGFR T790M resistance mutations months earlier than radiologic detection of progression in patients.

Early pharmacodynamic events occurring within hours or days of anti-EGFR drug treatment were evaluated in the study by implementing daily monitoring of urinary ctDNA. Initial results demonstrated that immediate changes in EGFR mutational load using a urine specimen may identify patients who respond to anti-EGFR therapy much earlier than with follow-up CT-scans. This new clinical utility of urinary ctDNA is being further validated in a larger patient cohort.

“These interim results suggest that use of urinary ctDNA has potential to detect EGFR T790M status in a higher number of study subjects and may make some patients eligible for therapy who would by tissue biopsy be falsely classified as negative,” says Dr. Husain. “Detecting the emergence of EGFR T790M mutations before progression has the potential to enable physicians to better align therapeutic selection and inform early therapeutic decision making.”

“These compelling data using a completely noninvasive specimen support the potential of our PCM platform to transform the way clinicians monitor and treat lung cancer patients,” says Antonius Schuh, PhD, Trovagene CEO. “Last year, we showed that we could detect and monitor the BRAF V600E mutation in histiocytic disease, and change the way clinicians diagnose and treat Erdheim-Chester disease. Today we are following the same course in lung cancer by identifying more patients with driver mutations, observing the immediate effects of targeted therapy, and tracking a key resistance mutation. We continue to add to the body of clinical evidence supporting our proprietary liquid biopsy platform for cancer monitoring, and remain focused on improving the standard of cancer care.”

For further information, visit Trovagene.