Credit: © Alex Tihonov/Fotolia

New research published in the Journal of Thoracic Oncology Clinical and Research Reports shows that Hummingbird Diagnostics’ blood-based 5-miRNA signature (miRisk) can predict survival in patients with non-small cell lung cancer (NSCLC) with high PD-L1 expression after they have received immunotherapy.

The results point to miRisk being able to answer a sticky question for oncologist of whether patients with advanced-stage NSCLC should receive only immunotherapy (IO) or if they should receive immunotherapy in combination with chemotherapy (ICT). Both treatment regimens are currently included in international clinical guidelines, yet to date there has been no biomarker associated with this stage of NSCLC that can help guide clinicians in choosing the therapy most appropriate for each patient. Having this information can help clinicians reduce the use of toxic chemotherapy regimens that can severely impact the quality of life for NSCLS patients.

“Patients with advanced, non-oncogene-driven, non-small-cell lung cancer with high PD-L1 expression are eligible for treatment with immunotherapy,” said Timothy Rajakumar, medical director of Hummingbird Diagnostics and first author on the study in a press release. “There is, however, an urgent medical need for biomarkers identifying cases that require additional combination with chemotherapy. The miRisk score represents an immune focused biomarker that is specifically predictive of response to immunotherapy and could serve as the foundation for a complementary diagnostic to guide therapeutic decisions and thereby allow physicians to more accurately choose between treating patients with IO alone vs. ICT.”

The study, which builds on results published in March in npj Precision Oncology, was performed in collaboration with the Thoraxklinik at Heidelberg University Hospital under the direction of Prof. Petros Christopoulos and also with Prof. Martin Reck. The study cohort comprised 155 blood samples prospectively collected from patients with stage IV NSCLC with PD-L1 TPS ≥50%, before they had been initiated on treatment with IO or ICT. Using small RNA sequencing techniques the team used the data from the samples to train and validate a 5-microRNA model (miRisk) to predict overall survival (OS). Not only was the model developed significantly associated with OS, but also with the type of therapy—either IO or ICT—offering promise as a tool to support clinical decision making.

“We believe our analysis will provide a blueprint for host-based integrative biomarker usage in a field of pressing medical need with the emergence of more complex immunotherapy regimens,” said Bruno Steinkraus, CSO of Hummingbird Diagnostics. “Taken together with the relatively simple use of a peripheral whole-blood test that does not require pipetting at point of care, we envision applicability of this technology to non-invasive therapy guidance for the IO or ICT decision in PD-L1 high patients.”

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