IntegraGen Presents Positive Data at 2016 ASCO Meeting on the Role of microRNA Biomarker miR-31-3p in Patients with Metastati...
June 06 2016 - 2:00AM
Business Wire
Data reports miR-31-3p expression predicts
improved survival and response with anti-EGFR therapy compared to
anti-VEGF therapy in patients with metastatic colorectal cancer
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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INTEGRAGENBernard COURTIEUPresident and CEOorLaurence
RIOT LAMOTTEChief Financial Officercontact@integragen.comTel: +33
(0)1 60 91 09 00orNEWCAP.Investor and Media
RelationsEmmanuel HUYNHLouis-Victor DELOUVRIERNicolas
MERIGEAUintegragen@newcap.frTel: +33 (0)1 44 71 94 94
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