On September 4, 2018 IntegraGen (FR0010908723: ALINT – PEA-SME Eligible), a company specializing in the transformation of data from biological samples into genomic information and diagnostic tools for oncology, reported the publication of the results of a definitive study reporting on the analysis of the expression of miR-31-3p in tumors from 370 RAS wild-type (WT) metastatic colorectal cancer (mCRC) patients enrolled in the FIRE-3 clinical trial (AIO KRK-0306) (Press release, Integragen, SEP 4, 2018, View Source [SID1234529334]). The paper, entitled "Validation of miR-31-3p Expression Level to Predict Cetuximab Efficacy When Used as First-Line Treatment in RAS Wild-Type Metastatic Colorectal Cancer" was published online in Clinical Cancer Research, a leading oncology journal which focuses on innovative clinical and translational cancer research studies that bridge the laboratory and the clinic.

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The study found that a low expression of the miR-31-3p biomarker predicts both improved survival and treatment response in patients receiving anti-EGFR therapy. In addition to confirming miR-31-3p is predictive of outcomes for RAS WT mCRC patients treated with anti-EGFR therapy, the study also found that patients with a miR-31-3p expression below a pre-defined threshold have a one year longer median overall survival, a 40% reduction in mortality risk, and a better treatment response when they are treated with FOLFIRI plus cetuximab compared to FOLFIRI plus bevacizumab. Conversely, no difference in outcomes was seen between the two treatment groups in patients with miR-31-3p expression above the pre-defined threshold. These results support the use of miR-31-3p expression testing in primary tumors from RAS WT mCRC patients to assist clinicians to identify the most appropriate first line biologic therapy may be most beneficial.

"The results of our study demonstrate the ability for miR-31-3p to predict which patients with RAS wild-type metastatic colorectal cancer will have improved outcomes when treated in first line with cetuximab compared to bevacizumab when combined with FOLFIRI therapy," explained Prof. Dr. Sebastian Stintzing, an oncologist from University Hospital, LMU Munich in Munich, Germany and lead author on the paper. "These findings are particularly significant since nearly two-thirds of the patients with RAS wild-type tumors in our study had low miR-31-3p expression levels and would therefore benefit from being treated with cetuximab versus bevacizumab as first line therapy for mCRC."

"The results from this study confirm the ability of the miR-31-3p biomarker to predict anti-EGFR therapy response, and in turn, demonstrates the clinical utility of this biomarker for patients with metastatic colorectal cancer," stated Dr. Bernard Courtieu, IntegraGen’s CEO. "This data demonstrates that the use of miR-31-3p expression testing can guide the choice of first line biologic therapy in RAS wild-type patients and enable oncologists to better select a personalized therapeutic approach, resulting in an improved opportunity for positive patient outcomes and decreased cost of care."

IntegraGen will presenting new data reporting positive results from an analysis of miR-31-3p expression in over 1,400 resected stage III colon cancer patients enrolled in the PETACC-8 trial during the upcoming 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany.

IntegraGen has commercialized the miRpredX 31-3p kit, a proprietary IVD CE Marked kit and has also licensed its intellectual property associated with miR-31-3p to GoPath Laboratories for the North American market. GoPath Labs recently announced the commercial launch of miR-31now, a laboratory developed test which measures miR-31-3p expression in FFPE specimens.

ABOUT THE FIRE-3 CLINICAL TRIAL

The FIRE-3 (AIO KRK-0306) clinical trial is an independent, randomized, controlled Phase III trial conducted in Europe and led by University Hospital, LMU Munich, Germany. The study compares outcomes of KRAS Exon 2 wild-type (WT) stage IV colorectal cancer patients randomized to receive FOLFIRI therapy (5-FU, folinic acid and irinotecan) in combination with either cetuximab or bevacizumab.