Personalised medicine requires new strategies for cancer drug
development
01 Dec 2010
Developments in the understanding of cancer biology could lead
to more effective, personalized treatments for millions of cancer
patients. However, to make the most of this coming transformation,
governments, pharmaceutical companies and doctors urgently need to adapt
the way drugs are developed.
The era of personalized oncology requires new thinking from all
these parties, according to experts attending the Cancer Biology for
Clinicians Symposium organized by the European Society for Medical
Oncology (ESMO) in Nice last week.
"Cancer therapy is arguably at the most exciting time in its
history," said José Baselga, from MGH Cancer Center in Boston, USA,
co-chair of the symposium and ESMO Past-President. "It is at the
confluence of two new movements, one toward personalized medicine
and the other toward the use of new molecularly targeted cancer
therapeutics that exploit the tumour's genetic and molecular
signature. These movements provide many challenges, but also the
opportunity for making paradigm shifts in the way we think of and
treat cancer."
Personalized treatment has become increasingly available for
cancers over the past decade. This has partly come about as
scientists have found that common tumours such as breast cancer are
in fact a mixture of several disease types with distinct molecular
features. Meanwhile, molecular targeted drugs have also been
developed that inhibit particular molecular targets involved in some
cancers.
"As our understanding of cancer biology develops further, these
kinds of personalized treatments are expected to become available
for many more cancer types," said Fabrice André, ESMO spokesperson
from Institut Gustave Roussy, France, co-chairing a session at the
symposium. "If we want to facilitate the implementation of this kind
of personalized medicine, then we urgently need to develop new
strategies for cancer drug development."
In particular, it is time to rethink whether the standard model
of testing drugs in large phase-III trials is an effective way to
bring these targeted cancer drugs to patients, Dr André noted.
"Regulatory processes are becoming increasingly restrictive in
providing patient access to potentially innovative new drugs,
because even the largest cancer trials generally involve only a
small portion of the cancer patient population, and because the drug
development process is often more than a decade from the first
preclinical study," he added.
This is related to the fact that drug approval usually needs
large confirmatory trials that are being done in an unselected
population. There is a need for smaller trials done with selected
patients to be highly sensitive, a concept that requires the
development of molecular selection and relative platforms for doing
that.
"It’s clear that we urgently need a new paradigm for drug
development, including targeted patient selection for clinical
trials, shorter duration of clinical trials and improvement of the
cost effectiveness of bringing a new drug to the market."
The ESMO Cancer Biology for Clinicians Symposium, a two-day
meeting featuring some of the most eminent researchers in the field,
is designed to inform oncologists about the ways cancer biology is
changing clinical practice.
"What is most exciting today is the active dialogue between
clinicians and laboratory scientists who share an interest in
applying the new knowledge of cancer biology to the diagnosis,
treatment, and prevention of the disease," said meeting co-chair
Mario Dicato, from Centre Hospitalier de Luxembourg.
"In the near future, cancer treatment decisions will be based on
biology," said the third meeting co-chair Jean-Charles Soria, ESMO
spokesperson from Institut Gustave Roussy, France. "It is therefore
vital that medical oncologists have the skills and the knowledge to
bring these advances to their patients. The future of oncology will
be personalized medicine, and the community needs to discuss how
this will be implemented."