Download Biomarkers: Signals of hope from the personalized treatment of cancer

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Biomarkers: Medicine of the future today
Biomarkers: Signals of hope from the personalized
treatment of cancer
 These signals predict the clinical evolution of the disease in a patient and the expected
response or benefit against every particular therapy.
 They facilitate decision-making and establish differentiated diagnosis.
San José, January 11th, 2011. Identifying overexpression of a protein known as HER2 in breast cancer
tumors allows doctors to predict the evolution the
patient will have with the disease. Moreover, this
facilitated Medicine in creating targeted or
“personalized” therapies, such as
Herceptin
(trastuzumab, Roche), which inhibit tumor growth and
increases survival in these patients. It is currently
known that in a group of patients with an early
diagnosis of HER2-positive breast cancer, Herceptin
reduces the risk of disease progression in 24%.1
This is all possible due to “biological markers “ or
“biomarkers”. These are proteins present in different
types of cancers, which, according to the tumor, could
mutate, or to be present in variable amounts, and thus,
they not only may predict the development of the
disease, but also the response a patient could have with
a particular therapy.
Due to its role in decision-making, biomarkers have
become the “medicine of the future”. These signals
play a fundamental role in establishing differentiated
diagnosis. They also enjoy prognostic capabilities,
indicating the evolution of the disease and its
aggressiveness in each different person, providing also
a predictive value, in relations to response or benefit of
the patient against different treatments.
Bio-drugs and biomarkers
With the discovery of certain biomarkers in some types of
cancers, scientific research has established the
convenience of using some bio-drugs for medical
treatment. Bio-drugs are medicines manufactured through
a biotechnological process in order to obtain identical
replications of a human protein, with therapeutic
potential. For example:
Tarceva: It is a bio-drug that acts by blocking
uncontrolled growth signals issued by the epithelial
growth receptor (EGFR). This receptor is found in a
mutant state in 15% of non-small cell lung cancers.
Herceptin: It recognizes the HER-2 receptor (biomarker)
and inhibits it. In other words, the drug blocks the protein
that makes the tumor grow, at the cellular level.
Mabthera: It is a bio-drug used in Non-Hodgkin
lymphoma. It recognized the CD20 marker (biomarker)
found, with the disease, on the cell surface of white blood
cells. The drug recognized the marker, activates the
immune system and stimulates it to destroy those cells. It
also exerts direct toxicity on those cells.
Source: ROCHE
For all these reasons, the number of biomarkers with a potential clinical interest grows every year; many of
1
HERA: Luca Gianni. St. Gallen. March 2009
them have been already approved by regulatory agencies or are currently in advanced stages of research. The
pharmaceutical company Roche is a world leader in this matter.
“Science starts to guide research towards oncology treatments in a personalized manner, and it does so
through these ‘molecular targets‘, in other words, the specific alterations shown by a cancer. This has allowed
the development of specific therapies, designed to target very concrete functions of particular markers”,
explained Marco Castillo, Medical Director at Roche.
In some cases, biomarkers indicate whether a given type of treatment will be effective in a patient, in such a
way that it is possible to prevent a person from being subject of an aggressive treatment that will not be
effective either.
Origin and findings
The term biomarker is relatively recent and it got positioned as the focus of medical research in the past 15
years. Nevertheless, the first findings took place several centuries ago; for example, physicians, pathologists
and surgeons in the 1800´s discovered the hormone-dependent nature (estrogens) of some types of breast
cancer. Later on, this finding allowed the development of drugs specifically targeted to this alteration, and
thus blocking its effect, making it possible, in some occasions, to prevent the removal of the organs affected
by cancer.
To this date, scientific evidence is even more clear: more than 10 years ago it was demonstrated that when
breast cancer over-expresses the HER2 protein, this cancer will be more aggressive and medical prognosis
will be worse for the patient. Furthermore, with this type of cancer, the known chemotherapy had a limited
effectiveness.
Cancers over-expressing this protein is known as HER2-positive, and they happens in approximately 25% of
patients diagnosed with breast cancer. Today, that 25% of patients have an alternative to be kept alive due to
this technology of biomarkers, through which a targeted therapy has been developed – Herceptin - thus
generating a better response and blocking tumor growth
“In those cases where tumor size must be reduced before surgery, evidence demonstrated that the number of
patients, progression-free for a period of three years, was 17% higher than those patients using traditional
treatment only; furthermore, in those who received targeted therapy, the risk of disease relapse was reduced
in 40%2” expressed Marco Castillo, Medical Director at Roche.
Another significant example of the importance of biomarkers was evident in a trial conducted by Dr. Rafael
Rossell and published at the New England Journal of Medicine in 2009. It demonstrated that a group
advanced lung cancer patients exhibiting a genetic mutation in the EGFR biomarker was more sensitive to
treatment with Tarceva (Erlotinib); today we know that, in such cases (approx. 10% of the total number of
patients with the disease), therapy with this drug triples the median survival of patients from 9 to 27 months 2,
against traditional chemotherapy alone.
Disease testing
The worldwide trend is to move towards a personalized form of medicine, given each disease has a different
way of expression; there are molecular variants or mutations of the same tumor, making it to behave in a
different manner, against several therapies or drugs.
Within this context, diagnosis by biomarkers is determinant. Investigators have already discovered biological
markers for diseases so complex as gastric, colon, breast, lung, kidney and brain cancer, as well as for NonHodgkin lymphoma and chronic lymphocytic leukemia, among others.
The diagnosis showing the presence of biomarkers in a given type of cancer is made through complex
laboratory clinical tests (automated and manual); some of these tests are conducted on blood samples and
other through biopsies taken from samples of cancer tumors, subject of different solutions and reactants.
ROCHE
Roche is a leader in research focused healthcare, with combined strengths in pharmaceuticals and diagnostics. Roche is
the world’s largest biotechnology company and it has authentically differentiated drugs in the areas of oncology,
virology, inflammation and the central nervous system. Roche is also the world leader in in-vitro diagnostics and in
tissue-based cancer diagnostics. Roche is a pioneer in diabetes control. Roche’s personalized healthcare strategy is
aimed to provide drugs and diagnostic tools that enable tangible improvements in health, quality of life and the hope of
survival for patients. Roche is headquartered in Basel (Switzerland).
More information in www.roche.com
Media contact: Alejandro Brokke, cel. +506 88553914
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