OBJECTIVES: Comprehensive Genomic Profiling (CGP) is a Next-Generation Sequencing (NGS) cancer diagnostic approach that maximizes the chances of finding an actionable target to direct personalized treatment. This project aimed at investigating the experience of Italian outsourced CGP service users -both oncologist and pathologist- and how it impacted their clinical practice in 2019 in lung cancer patients, investigating characterizations of patient, logistics and clinical impact.

METHODS: A modular approach was designed to capture the impact of outsourced CGP service in clinical practice. Three therapeutic area experts (two oncologists and one pathologist) were then involved in a dedicated workshop to define the key metrics to be investigated in a Real World Evidence (RWE) survey. After the interview of 25 clinicians, the same three experts reviewed and discussed surveys output.

RESULTS: The project highlights the following key points: i) CGP have been mainly used for relatively young patients [84.3% less than 70 years]. The majority of analyzed patients is diagnosed with primary non-small cell lung cancer (NSCLC) [95.2%] and stage IV [89.4%]. Most patients [73.9%] are naïve or had maximum one line of treatment; ii) a low but not negligible failure rate [8.5%] is observed for tissue, because the tissue is not often collected or stored in a suitable/optimal way for complex CGP procedure; iii) CGP is finally able to identify a viable therapeutic option for more than half patients [52.6%]: for 23.5% an on-label drug, for 18.4% an off-label drug, and for 10.7% an available clinical trial.

CONCLUSIONS: Overall, the impact of CGP on clinical management was remarkable: more than half of tested patients had a clinically actionable mutation and only approximately one fourth of the biomarkers detected had an on-label drug. This highlights the need for more clinical studies and faster approval pathways for novel drugs that target actionable mutations.