New England Journal of Medicine Publishes MINDACT Trial Results Proving the Clinical Utility of MammaPrint® in Assisting Physicians to Identify Early-Stage Breast Cancer Patients who can Safely Forgo Chemotherapy

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  • 46% of patients identified as high risk for recurrence according to
    clinical-pathological factors as described in the publication, and who
    therefore would be usual candidates for adjuvant chemotherapy, were
    reclassified as Low Risk by MammaPrint® and MINDACT shows could
    possibly forgo chemotherapy[i]
  • MammaPrint could change clinical practice by providing critical
    prognostic information to aid in assessing patients’ risk for distant
    metastasis and potentially sparing over one hundred thousand women
    annually[ii] with early-stage breast cancer worldwide from
    unnecessary toxicities and side effects from chemotherapy and creating
    considerable cost savings
  • As demonstrated in the MINDACT trial, MammaPrint is now the only
    FDA-cleared breast cancer prognostic test with the highest level of
    evidence (1A) for its clinical utility to aid correctly identifying
    Low Risk patients

IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)–Agendia, Inc., a world leader in personalized medicine and molecular
cancer diagnostics, announces the peer-reviewed publication of the
primary outcome results of the Microarray In Node-negative
and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy
(MINDACT) clinical trial in the prestigious New England Journal of
Medicine (NEJM). [i, iii, iv] The publication demonstrates
that 46% of breast cancer patients considered for chemotherapy, whose
tumors are classified MammaPrint Low Risk, have excellent survival
without chemotherapy, and can thus be candidates to avoid this toxic
therapy. [i, pg. 717]

MINDACT is a collaboration between Agendia, the European Organization
for Research and Treatment of Cancer (EORTC) and the Breast
International Group (BIG). A unique phase III prospective, randomized,
controlled study of 6,693 patients across 112 European cancer centers,
MINDACT provides the highest level of clinical evidence (Level 1A) and
confirms the clinical utility of using Agendia’s MammaPrint 70-gene
breast cancer recurrence assay to help predict clinical outcome in women
with early-stage breast cancer.

“When we developed MammaPrint, we knew we wanted to achieve the same
level of evidence required for a typical pharmaceutical drug. That is
why we are one of only a few diagnostic tests with FDA clearance and why
we rigorously evaluated MammaPrint in the context of
clinical-pathological factors in the randomized MINDACT trial,” said
Prof. Laura van ’t Veer, Chief Research Officer at Agendia, and Leader,
Breast Oncology Program, and Director, Applied Genomics at UCSF Helen
Diller Family Comprehensive Cancer Center. “Now indeed, we have the only
genomic assay with Level 1A evidence to help physicians more accurately
predict risk of distant metastasis in patients with early-stage breast
cancer.”

MINDACT is the first prospective translational clinical study of this
magnitude in early-stage breast cancer to report the results of its
primary objective and publish them in a peer-reviewed journal. At 5
years, patients who did not receive adjuvant chemotherapy but were
classified as being at high risk for breast cancer recurrence based on
clinical-pathological factors and as being at Low Risk based on
MammaPrint, had similar rates of disease free survival. [i, pg. 717]

“The design of the MINDACT trial proves the clinical utility of the
MammaPrint assay,” said Dr. Gabriel Hortobagyi, MD, FACP, FASCO
Professor and Chair Emeritus of the Department of Breast Medical
Oncology at the MD Anderson Cancer Center (MDACC) and Chair of the
Agendia Inc. Medical Advisory Board. “The reporting of these conclusive
results of the trial will now give physicians increased confidence that
in using MammaPrint, their treatment decisions will be based on the
highest level of clinical evidence and will minimize the incidence of
over- or under-treatment.”

“We understand that a risk–benefit assessment and decisions with respect
to the use of adjuvant chemotherapy are highly variable and personalized
among physicians and individual patients. However, these findings
provide clinical utility by demonstrating that MammaPrint’s accuracy in
helping to detect patients with a low risk of distant recurrence could
be safely used in the management of over one hundred thousand[ii]
women and potentially spare them from unnecessary chemotherapy,” said
Dr. William Audeh, Chief Medical Officer at Agendia. “The toxicities and
side effects of chemotherapy may outweigh the potentially small and
non-statistically significant benefit (1.5% 95% CI, 0.50 to 1.21; p =
0.27) of chemotherapy in women at high risk based on clinical factors
but at Low Risk per MammaPrint. Thus, physicians and breast cancer
patients may on an individual basis decide to avoid it.”

In MINDACT, when the authors looked at the patients with the most common
type of breast cancer, hormone receptor positive, human epidermal growth
factor receptor 2 negative, and lymph node negative (HR+/HER2-/LN0)
disease, 75% were identified as having a Low Risk of recurrence using
MammaPrint. The Distant Metastasis Free Interval (DMFI) for these
patients (which according to the researchers is the optimal endpoint to
evaluate a genomic assay that looks at prognosis and benefit of
chemotherapy treatment) was 97.8% without chemotherapy. [i,
supplement pg. 12-13]

In MINDACT, this MammaPrint Low Risk group of breast cancer patients who
may be candidates to forgo chemotherapy is over four times larger than
the proportion identified with a low-Recurrence Score® (RS) in both
TAILORx.[v] and Plan B.[vi]. The TAILORx trial,
which is the trial that would validate the appropriate cut-offs for the
Oncotype DX® 21-gene breast cancer recurrence assay, has only reported
data on the low risk arm of the study that included 15% of the patients
who are in the non-randomized arm of patients with RS 10 and under. The
TAILORx trial, has not presented results of its primary objective of the
outcome of patients with RS between 11-25.

“MINDACT provides us with the highest level of evidence to support what
we at Agendia have always believed, that MammaPrint is a definitive,
accurate and clinically relevant breast cancer recurrence assay. The
quality of life and cost efficiency implications of helping physicians
choose the appropriate management for women with breast cancer is the
reason we do what we do every day,” commented Mark Straley, Chief
Executive Officer, Agendia. “We understand that ultimately, the decision
to receive or forgo chemotherapy lies with each patient and physician
who is properly informed about the potential side effects and benefits
of such treatment. Nonetheless, MammaPrint could potentially change the
standard of care and we look forward to its recommendation for inclusion
in all early-stage breast cancer management guidelines. This will ensure
that even more patients, physicians and healthcare systems are aware of
the benefits of MammaPrint-based management decisions.”

Breast cancer is the most frequently diagnosed cancer in women worldwide.[vii]
In 2012, there were nearly 1.7 million new breast cancer cases
among women worldwide, accounting for 25% of all new cancer cases in
women.[viii] MINDACT initial results were selected for a
prestigious breakthrough presentation at the AACR
Annual Meeting 2016
, 16-20 April.

For more information on the MINDACT trial publication, please visit the
Agendia newsroom: http://www.agendia.com/agendia-news-and-press-releases/

[i] Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene
Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer.
N Engl J Med 2016; 375: 717-29.
[ii] Based on applying
MINDACT risk data to: American Cancer Society. Global Cancer Facts &
Figures 3rd Edition. Atlanta: American Cancer Society; 2015. (online)
and American Cancer Society. Breast Cancer Facts & Figures 2015-2016.
Atlanta: American Cancer Society, Inc. 2015.
[iii] Hudis
CA, Dickler, M. Increasing Precision in Adjuvant Therapy for Breast
Cancer. N Engl J Med 2016; 375: 790-91.
[iv] For
disclosures regarding involvement in trial, see page 728 of publication
(Cardoso F. NEJM 2016) mentioned above.
[v] Sparano JA,
Gray RJ, Makower DF, et al. Prospective validation of a 21-gene
expression assay in breast cancer. N Engl J Med 2015; 373: 2005-14.
[vi]
Gluz O, Nitz, U. A., Matthias, C, et al. West German Study Group Phase
III Plan B Trial: First Prospective Outcome Data for the 21-Gene
Recurrence Score Assay and Concordance of Prognostic Markers by Central
and Local Pathology Assessment. J Clin Oncol 2016; 34(20):2341-9
[vii]
World Health Organization. Breast cancer: prevention and control.
Website. http://www.who.int/cancer/detection/breastcancer/en/index1.html
Accessed March 2016.
[viii] American Cancer Society.
Global Cancer Facts & Figures 3rd Edition. Atlanta: American Cancer
Society; 2015. (online)

About MINDACT

MINDACT is a prospective, randomized, phase III, controlled
clinical trial
 that investigates the clinical utility of MammaPrint,
when used in conjunction with standard clinical pathological criteria,
for the selection of patients unlikely to benefit from adjuvant
chemotherapy. From 2007 to 2011, 6,693 women who had
undergone surgery for early-stage breast cancer enrolled in the trial,
across 112 centers in nine countries. Patients were categorized as low
or high risk for tumor recurrence in two ways: first, through analysis
of tumor tissue using MammaPrint; and second, using Adjuvant! Online, a
tool that calculates risk of breast cancer recurrence based on common
clinical pathological factors. Patients characterized in both clinical
and genomic assessments as low risk are spared chemotherapy, while
patients characterized as high risk are advised chemotherapy. Those with
discordant results were randomized to use either clinical or genomic
risk (MammaPrint) evaluation for chemotherapy treatment.

MINDACT is a population based trial. A risk–benefit assessment and
decisions with respect to the use of chemotherapy are highly variable
among physicians and patients, and even national and international
guidelines differ in their recommendations. Ultimately, the decision to
receive or forgo chemotherapy (or any other treatment) lies with each
patient who is properly informed about the potential side effects and
the potential benefits of such treatment. For the same risk–benefit
scenario, different patients may make different decisions. [i, pg.
727-28]

About MammaPrint

MammaPrint is a FDA-cleared in vitro diagnostic test, performed in a
single laboratory, using the gene expression profile of breast cancer
tissue samples to assess a patients’ risk for distant metastasis. The
MammaPrint result is indicated for use by physicians as a prognostic
marker only, along with other clinical-pathological factors. MammaPrint
is not intended for diagnosis, or to predict or detect response to
therapy, or to help select the optimal therapy for patients. Results
should be taken in the context of other relevant clinical-pathological
factors and standard practice of medicine.

About Agendia

Agendia is a privately held, leading molecular diagnostics company that
develops and markets FFPE-based genomic diagnostic products, which help
support physicians with their complex treatment decisions. Agendia’s
breast cancer and colorectal cancer tests were developed using an
unbiased gene selection by analyzing the complete human genome. Our
offerings include the FDA-cleared MammaPrint FFPE 70-gene breast cancer
recurrence assay as well as BluePrint®, a molecular subtyping assay that
provides deeper insight leading to more clinically actionable breast
cancer biology. These tests can help physicians assess a patient’s
individual risk for metastasis – that is, which patients are more
sensitive to chemo, hormonal, or combination therapy, and which patients
may not require these treatments and which patients may be treated with
other, less arduous and costly methods.

In addition, Agendia has a pipeline of other genomic products in
development. The company collaborates with pharmaceutical companies,
leading cancer centers and academic groups to develop companion
diagnostic tests in the area of oncology. For more information, visit www.agendia.com.

Contacts

FleishmanHillard (US media)
Scott Speer, (310) 482-4283
scott.speer@fleishman.com
or
Instinctif
Partners (EU media)
Léon Melens / Lynne Trowbridge / Jen Lewis
T
+31 (0) 6 538 16 427 / +44 (0) 20 7457 2020
agendia@instinctif.com