Agendia Highlights Study Showing MammaPrint/BluePrint Tests Predict Response to Current Breast Cancer Chemotherapy and Targeted Therapy Regimens

Researchers Present Data at Breast Cancer Symposium Showing
MammaPrint/BluePrint Can Identify Women Who Benefit from Chemotherapy
and Targeted Dual Anti-HER2 Drug Treatment Before Surgery

IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)–Agendia’s MammaPrint® and BluePrint® tests provide new insights that may
provide many more women with beneficial treatment for breast cancer
before surgery, according to findings presented at the 2015 Breast
Cancer Symposium.

Researchers analyzed a cohort of 889 early-stage breast cancer patients
in the NBRST (“N-breast”) study who had functional molecular subtyping
with the BluePrint test. The data underscored the ability of MammaPrint
and BluePrint to predict the result of contemporary, commonly used
chemotherapy and targeted therapy regimens. A competing assay, by
comparison, has been validated to be predictive with older chemotherapy
regimens that are less widely used today.

The analysis presented at the Breast Cancer Symposium identified a
substantial group of patients who were said to be, by standard IHC-FISH
clinical lab testing, HER2-positive and ER-positive — but who did not
respond well to the type of neoadjuvant (presurgical) treatment that is
usually prescribed for patients believed to be HER2+ and ER+ by IHC-FISH.

Researchers discovered that the MammaPrint-BluePrint tests in fact
reclassified a group of these patients as having the Luminal-type
molecular subtype of breast cancer. For this group, when another drug
called pertuzumab (Perjeta®) was added to their presurgical treatment,
these women had a far greater benefit from therapy (10-fold increase),
as measured by whether they had a pathologic complete response (pCR)
when treated with chemotherapy before their surgery.

“These Luminal-type patients are far less likely to benefit from the
standard use of neoadjuvant chemotherapy and trastuzumab (Herceptin®),”
as measured by whether or not they had a pCR,” said Peter Beitsch, M.D.,
who presented the findings in a podium talk at the Breast Cancer
Symposium. “By contrast, we found that the pCR rate among these
Luminal-type molecular subtypes was nearly 10 times better if their
neoadjuvant treatment also included pertuzumab along with chemotherapy
and trastuzumab.

Agendia’s BluePrint gives better ID of #breastcancer molecular subgroups
to predict presurgical treatment. #BCS15 See

“This research may upend the conventional thinking and resolve a
well-known conundrum in breast cancer research,” he said. “Many
HER2-positive and ER-positive patients, as identified by IHC-FISH,
respond well to presurgical chemo and trastuzumab, though as a group not
nearly as well as HER2-positive and ER-negative patients. There is a
subgroup of HER2-positive, ER-positive patients whose cancers do not
respond favorably to that standard treatment. These new findings
indicate the tumors in this subgroup are in fact Luminal-type (not HER
type) molecular subtype as assessed by BluePrint. For better survival,
this group of patients may require dual drug treatment that combines
pertuzumab with chemotherapy and trastuzumab.”

Agendia CEO Mark Straley underscored the significance of the research:
“These findings are further evidence that Agendia’s research and
development place us in a unique position to work with pharmaceutical
companies, to better understand breast cancer biology and to refine
treatment by predicting response,” Straley said. “Predicting which
patients will benefit the most from costly and potentially toxic
therapies – and which patients can safely forego them – is a critically
important part of improving breast cancer care. Agendia’s assays
continue to demonstrate that they can help physicians make the most
personalized and most current predictive treatment decisions for each
breast cancer patient.”

Among the findings presented in Dr. Beitsch’s talk were these:

  • MammaPrint/BluePrint reclassified 23% of patients and yielded
    significantly better correlation with both neoadjuvant chemotherapy
    responsiveness and resistance compared to IHC-FISH
  • MammaPrint/BluePrint subtyping divided triple positive (HER2+/ER+/HR+)
    cancers into Luminal-type and HER2-type molecular subtypes of
    approximately equal proportion
  • Triple positive/BluePrint Luminal-type cancers are relatively
    resistant to NCT/trastuzumab
  • Perjeta added to NCT/trastuzumab overcomes this resistance.

“We believe this data is the first prospectively gathered evidence of
its kind,” said Dr. Beitsch. “It provides further evidence for the
substantial value of functional molecular subtyping and its utility in
predicting which patients will require dual neoadjuvant drug therapy,
combining trastuzumab and pertuzumab.”

Agendia’s MammaPrint 70-gene assay and BluePrint 80-gene molecular
subtyping assay are the most widely available tests that provide the
functional molecular subtype of a woman’s breast cancer. Molecular
subtyping is a form of precision
increasingly used to personalize treatment. It allows
physicians to more accurately understand the biology of a woman’s breast
cancer and better allocate treatment that fits her particular cancer.
The MammaPrint 70-gene assay has received FDA 510(k) clearance for use
in FFPE tissue samples. MammaPrint was the first breast cancer risk of
recurrence multi-gene assay to receive FDA 510(k) clearance. With the
most recent clearance, Agendia now has six FDA clearances in its breast
cancer portfolio.

Among the study co-authors were Pat Whitworth, M.D. a surgical
oncologist at Nashville Breast Center, and clinicians from 11 other
institutions around the U.S. Dr. Beitsch is Director of the Dallas
Breast Center and practices at North Central Surgical Central Hospital.
A widely published researcher, he is a Fellow of the Society of Surgical
Oncology and past President of the American Society of Breast Surgeons.

The 2015 Breast Cancer Symposium was held Sept. 25-27 in San Francisco.
It was cosponsored by the American Society of Clinical Oncology, the
Society of Surgical Oncology and the American Society for Radiation

Resources for further reference

  • Video
    of Dr. Pat Whitworth discussing the initial NBRST study
  • NCCN Breast Cancer Guidelines Acknowledge MammaPrint’s Ability to
    Predict Prognosis press
  • Independent comparison validates molecular
    (includes video)
  • RASTER prospective outcome study
    and press

About Agendia

Agendia is a privately owned, leading molecular diagnostic company that
develops and markets FFPE-based genomic diagnostic products, which help
support physicians with their complex treatment decisions. Agendia’s
breast cancer suite was developed using an unbiased gene selection by
analyzing the complete human genome.

This includes the MammaPrint test, which is the only FDA-cleared test
for women of all ages and which is not limited by estrogen receptor
status. Agendia’s suite of tests includes BluePrint, which in
combination with MammaPrint provides the only commercially available way
to predict response to current breast cancer chemotherapy and targeted
therapy regimens. In addition to MammaPrint and BluePrint, which is a
molecular subtyping assay that provides deeper insight leading to more
clinically actionable biology, Agendia also offers TargetPrint®, an
ER/PR/HER2 expression assay.

MammaPrint has six FDA clearances and is the only breast cancer
recurrence assay backed by peer-reviewed, prospective outcome data.
Agendia’s tests help physicians assess a breast cancer patient’s
individual risk for metastasis, which patients may benefit from chemo,
hormonal, or combination therapy, and which patients may not require
these treatments and can instead be treated with other, less arduous and
less 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 and is a critical partner in
the I-SPY 2 and the MINDACT trials. For more information, visit


Dowling & Dennis Public Relations
Liz Dowling, 415-388-2794
& Consumer Media
SPJ Financiële
& Corporate Communicatie
Léon Melens, +31-20-647-81-81