IntegraGen Announces Publication of Data Which Demonstrates the Ability of miR-31-3p to Predict Response to Therapy for Patie...
04 Septembre 2018 - 8:00AM
Business Wire
Data published in Clinical Cancer Research
reports that low miR-31-3p expression predicts improved survival
and a better response to anti-EGFR therapy compared to anti-VEGF
therapy in patients with metastatic colorectal cancer enrolled in
the FIRE-3 clinical trial
Regulatory News:
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, today
announced 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). 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.
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.
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, 2017, IntegraGen had 40 employees and
had generated revenue of €6.1 million in 2017. Based in Evry
Genopole, IntegraGen also has an U.S. office in Cambridge,
Massachusetts. IntegraGen is listed on Euronext Growth (ISIN:
FR0010908723 - Ticker: ALINT - PEA-SME).
For more information, visit www.integragen.com
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IntegraGenBernard COURTIEUPresident and CEOorLaurence
RIOT LAMOTTEChief Financial Officercontact@integragen.comTel.: +33
(0)1 60 91 09 00orNewCapInvestor and Media
RelationsLouis-Victor DELOUVRIERintegragen@newcap.euTel.: +33 (0)1
44 71 98 53
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