New Data on IntegraGen’s miR-31-3p Biomarker Featured in Presentation at 2016 ESMO Congress
October 10 2016 - 12:00PM
Business Wire
Data presented concludes that miR-31-3p
expression is predictive of anti-EGFR therapy effect on objective
response, depth of response, and early tumor shrinkage in patients
with metastatic colorectal cancer enrolled in prospective,
randomized FIRE-3 Trial
Regulatory News:
IntegraGen (Paris:ALINT), a company specializing in the
transformation of data from biological samples to actionable
genomic information and developer of diagnostic tools for oncology,
today announced the presentation of new clinical data demonstrating
the benefits of its miR-31-3p biomarker during the 2016 European
Society of Medical Oncology (ESMO) Congress being held in
Copenhagen. The new data, which was featured as an oral
presentation during a proffered plenary session during the meeting,
demonstrates that IntegraGen’s proprietary miR-31-3p biomarker is
predictive of anti-EGFR therapy effect on objective response, depth
of response, and early tumor shrinkage in wild-type (WT) metastatic
colorectal cancer (mCRC) patients. The miR-31-3p biomarker
identifies patients who have better efficacy from anti-EGFR therapy
(cetuximab) than with anti-VEGF therapy (bevacizumab). 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 on miR-31-3p during the 2016 ESMO Congress
builds upon data from a separate analysis of patients enrolled in
the FIRE-3 trial that was presented at the 2016 American Society of
Clinical Oncology (ASCO) Annual Meeting earlier this year which
demonstrated that patients with a miR-31-3p expression below a
pre-defined threshold treated with FOLFIRI plus cetuximab had a one
year longer median overall survival and a 40% reduction in
mortality risk compared to patients treated with FOLFIRI plus
bevacizumab. These results reconfirm that testing miR-31-3p
expression in RAS WT mCRC patients can help to identify which 1st
line biologic therapy may be most beneficial and support a
personalized, precision medicine approach to the care of cancer
patients.
“These new results show that miR-31-3p can identify which
patients with metastatic colorectal cancer will have improved
outcomes when treated in first line with cetuximab compared to
bevacizumab when combined with FOLFIRI therapy,” stated Professor
Pierre Laurent-Puig, M.D., Ph.D. from the Department of Genetics
and Head of the Clinical Oncogenetic Unit at the European Georges
Pompidou Hospital (HEGP) in Paris, France, Director of the INSERM
UMR-S 1147 Research Unit at the Paris Descartes University Medical
School, and lead author for the present study. “Having the ability
to proactively identify patients who will have a better treatment
efficacy with cetuximab when used in first line will enable
physicians to better select the most appropriate therapy which
provides the greatest clinical benefit for this patient
population.”
“We have shown that superior response outcome parameters such as
early tumor shrinkage and depth of response clearly correlate with
overall survival benefit in metastatic colorectal cancer patients
treated with biologic therapies,” 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. “The present study
demonstrated that the nearly two-thirds of the patients with RAS
wild-type tumors enrolled in the FIRE-3 study had low miR-31-3p
expression levels and would therefore have overall survival and
response benefits when treated with cetuximab versus bevacizumab as
first line therapy for metastatic colorectal cancer.”
“The results from this study provide yet more clinical evidence
that IntegraGen’s miR-31-3p biomarker can guide the appropriate
choice of first line biologic therapy for patients with metastatic
colorectal cancer,” stated Dr. Bernard Courtieu, IntegraGen’s CEO.
“The data featured during an oral presentation at this year’s ESMO
Congress further demonstrates that 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 plans to make a
miR-31-3p test available in 2017 to cancer specialists and
biologists in both Europe and the United States. We estimate that
the market for this test represents a $100 million annual revenue
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161010005829/en/
INTEGRAGENBernard COURTIEUPresident and CEOorLaurence
RIOT LAMOTTEChief Financial Officercontact@integragen.comTel: +33
(0)1 60 91 09 00orNewCapInvestors relationsEmmanuel
HUYNHLouis-Victor DELOUVRIERintegragen@newcap.euTel.: +33 (0)1 44
71 98 53
Integragen (EU:ALINT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Integragen (EU:ALINT)
Historical Stock Chart
From Jul 2023 to Jul 2024