Three New Studies Presented at San Antonio Breast Cancer Symposium Further Demonstrate Value of MammaPrint® and BluePrint® in Individualizing Treatment for Breast Cancer Patients

  • Long-term follow-up of early-stage breast cancer patients shows
    significant difference in how gene expression-based tests classify
    patients for adjuvant chemotherapy treatment, finds MammaPrint® the
    best predictor of distant cancer recurrence
  • MINT trial confirms stratification of patients classified by
    MammaPrint as High Risk into two sub-categories to help predict
    benefit of chemotherapy
  • MINDACT sub-study compared molecular subtyping using BluePrint
    with pathological classification, suggests that molecular subtyping
    with BluePrint is better correlated with outcome

IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)–Agendia, Inc., a world leader in personalized medicine and molecular
cancer diagnostics, highlights new data on its gold-standard MammaPrint
70-Gene Breast Cancer Recurrence Assay and BluePrint 80-Gene Molecular
Subtyping Assay, from three studies presented at the San Antonio Breast
Cancer Symposium last week.

Researchers from the University of South Florida Morsani College of
Medicine reported long-term follow-up data observing 148 patients who
were tested with MammaPrint, Genomic Health’s Oncotype DX® and
Clarient’s Mammastrat®. The study concluded that the different gene
expression-based breast cancer recurrence tests showed discordant
results, with only MammaPrint providing a definitive low or high risk
outcome. MammaPrint also correctly reassigned a low or high risk result
to intermediate Oncotype DX risk scores. The Agendia test was also the
best predictor of distant cancer recurrence on identifying 85% of the 13
patients who either died or suffered a distant metastasis as high risk,
compared to 54% for Oncotype DX and 62% for Mammostrat.1

The Multi Institutional Neo Adjuvant Therapy MammaPrint Project (MINT)
trial demonstrated the predictive value of MammaPrint in further
stratifying 183 patients classified as at high risk of their cancer
recurring into High1 or High2 risk classes. Coupled with BluePrint, the
study found that these MammaPrint high risk sub-groups together could
help predict the benefit of chemotherapy.2

The third presentation, a sub-study of the international, prospective,
phase III MINDACT trial, published in August 2016, compared molecular
subtyping using BluePrint to pathological classification. Molecular
subgroups within early-stage breast cancer (such as Luminal A, Luminal
B, HER2+, Basel-like) may help to best identify patients for specific
treatment approaches. A key conclusion was that molecular subtyping
using BluePrint was able to restratify 16% of patients, originally
classified pathologically high risk, to a low risk Luminal A-type group,
with excellent survival. The study suggests that molecular subtyping by
BluePrint is better correlated with outcome than pathological
classification.3

The MINDACT trial, which was published in the New England Journal of
Medicine, is a unique phase III prospective, randomized, controlled
study that provides the highest level of clinical evidence to
MammaPrint, above any other genomic assay, for making adjuvant
chemotherapy decisions in early-stage breast cancer. It included almost
7,000 patients, across 112 institutions in nine different European
countries.

William Audeh, MD, Chief Medical Officer at Agendia said: “As the only
gene expression-based breast cancer recurrence test supported by Level
1A clinical evidence, it is very good to see the value of MammaPrint,
and also BluePrint demonstrated by these new data at this important
symposium. The results highlight the benefit of these tests in providing
patients with early stage breast cancer, and their physicians, with the
confidence to make important, informed treatment decisions. It also
demonstrates the potential to further apply our technology to truly
individualize the prognosis and the prediction of the best breast cancer
treatment, one patient at a time.”

For more information on Agendia or the MammaPrint and BluePrint tests,
you can visit Agendia’s patient site at KnowYourBreastCancer.com or the
corporate site at Agendia.com.

Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep
up-to-date with the latest news.

1Russell S, et al. Long-term follow-up of early stage breast
cancer patients with results of MammaPrint, Oncotype DX, and MammoStrat,
risk classification assays. Poster presented at San Antonio Breast
Cancer Symposium. December 2016; San Antonio, Texas.
2Blumencranz
L, et al. Mint trial yields MammaPrint High1/High2 risk classes
associated with significant differences in pCR and receptor subtype.
Poster presented at San Antonio Breast Cancer Symposium. December 2016;
San Antonio, Texas.
3Cardoso F, et al. Can Surrogate
Pathological Subtyping Replace Molecular Subtyping? Outcome Results from
the MINDACT Trial. Poster presented at San Antonio Breast Cancer
Symposium. December 2016; San Antonio, Texas.

About MammaPrint

MammaPrint is a FDA-cleared in vitro diagnostic test, available from
FFPE sample, 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 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
Scott Speer (US media)
310-482-4283
scott.speer@fleishman.com
or
Instinctif
Partners
Léon Melens / Jen Lewis / Dana Garbe (EU media)
+31 6
538 16 427 / +44 20 7457 2020 / +49 30 2408304-11
agendia@instinctif.com