IntegraGen Presents Positive Data at 2016 ASCO Meeting on the Role of microRNA Biomarker miR-31-3p in Patients with Metastatic Colorectal Cancer Enrolled in FIRE-3 Clinical Trial

IntegraGen, a leading provider of genomic solutions which transform molecular information into clinical action, today announced the presentation of positive clinical results on its miR-31-3p biomarker during the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago. The data presented demonstrates that IntegraGen’s proprietary miR-31-3p biomarker is predictive for both survival and treatment response in patients receiving anti-EGFR therapy. These results are based on an 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). The data presented represents the first study comparing miR-31-3p expression in mCRC patients treated in first line with anti-EGFR vs. anti-VEGF therapy.

In addition to confirming miR-31-3p is predictive of improved outcomes for mCRC patients treated with anti-EGFR therapy, the study also demonstrated that patients with a miR-31-3p expression below a pre-defined threshold treated with FOLFIRI plus cetuximab have a one year longer median overall survival, a 40% reduction in mortality risk, and a better treatment response compared to patients treated with FOLFIRI plus bevacizumab. No difference in outcomes were seen between the two groups in patients with miR-31-3p expression above the pre-defined threshold. These results suggest that testing miR-31-3p expression in RAS WT mCRC patients can help identify which 1st line biologic therapy may be most beneficial.

"Our results show that miR-31-3p can predict which mCRC patients will have improved outcomes when treated in first line with cetuximab compared to bevacizumab when combined with FOLFIRI therapy,” said Professor Volker Heinemann, from the Department of Medical Oncology and Comprehensive Cancer Center at University Hospital Grosshadern in Munich, Germany and lead investigator for the FIRE-3 study. "These findings are extremely significant clinically 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 provide strong clinical evidence that IntegraGen’s miR-31-3p biomarker can predict the benefit of anti-EGFR therapy in mCRC patients,” stated Dr. Bernard Courtieu, IntegraGen’s CEO. "The data presented at this year’s ASCO meeting in patients enrolled in the landmark FIRE-3 study demonstrates that RAS wild-type mCRC patients would benefit from the analysis of miR-31-3p expression prior to the determination of which biologic agent to utilize as first line therapy. This aligns with a more personalized approach to cancer care and contributes to the ability to tailor therapies to patients who are more likely to have clinical benefit of these therapies.”

Dr. Courtieu also added that "IntegraGen is currently pursuing options for offering a commercial test based on the miR-31-3p biomarker to physicians and their patients, which we estimate represents a $100 million market opportunity worldwide.”

ABOUT THE FIRE-3 CLINICAL TRIAL

The FIRE-3 clinical trial is an independent, randomized, controlled Phase III trial conducted in Europe and led by Ludwig-Maximilians University in 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.

ABOUT INTEGRAGEN

INTEGRAGEN is a company specializing in deciphering the human genome and producing relevant and easily interpretable data for academic and private laboratories. IntegraGen’s oncology efforts provide researchers and clinicians with sophisticated tools for analysis and therapeutic individualization of treatment approaches allowing them to tailor therapy to the genetic profiles of patients. As of December 31, 2015, IntegraGen had 37 employees and had generated revenue of €5.6 million in 2015. Based in Evry Genopole, IntegraGen also has an U.S. office in Cambridge, Massachusetts. IntegraGen is listed on Alternext of Euronext Paris (ISIN: FR0010908723 - Ticker: ALINT - PEA-SME).

For more information on IntegraGen visit www.integragen.com.

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