Personalized Cancer Therapy Requires New Strategies for Cancer Drug Development

Millions of cancer patients worldwide may soon be able to receive more effective, personalized treatments for their disease thanks to developments in the understanding of cancer biology, experts will say at the Cancer Biology for Clinicians Symposium organized by the European Society for Medical Oncology (ESMO) in Nice, France on 26-27 November.

To make the most of this coming transformation, governments, pharmaceutical companies and doctors urgently need to adapt the way drugs are developed, the experts say.

"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 tumor'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 tumors 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, from Institut Gustave Roussy, France, ESMO spokesperson 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."

The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care. The organization is a powerful alliance of more than 6,000 committed oncology professionals from over 100 countries.

For more information:
Cancer Biology for Clinicians Symposium Program Book

This article was first published online at Onco'Zine - The International Cancer Network

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New European Academy of Cancer Sciences will Help Shape Future Oncology Policy

A new initiative designed to inform and educate policymakers at national, European, and global level about the needs of the oncology community was launched at Europe’s largest cancer congress, ECCO 15 – ESMO 34, the 15th congress of the European CanCer Organisation and the 34th congress of the European Society for Medical Oncology in Berlin, Germany.

Professor Alexander Eggermont, President of the European CanCer Organisation (ECCO), told the conference that the European Academy of Cancer Sciences would help keep the interests of cancer patients at the forefront of the policy agenda, and avoid policy decisions that had a negative impact on the practice of oncology medicine.

The Academy will be a virtual body, grouping together representatives of all cancer disciplines with outstanding scientific and academic backgrounds to provide knowledgeable and unbiased advice on matters of policy and priorities at the national, European and global level under the auspices of ECCO. “We hope it will become an important reference point for policymakers and professionals in the field of oncology research and oncology care, where they can go to ask questions and receive suggestions and advice. It will be an independent organism, with the secretariat provided by ECCO, with whose Policy Committee it will work closely in the beginning,” said Prof Eggermont.

“We hope that, by keeping a close eye on policy developments that might affect cancer and offering expert advice to those responsible for decision-making, we will be able in future to avoid some of the recent decisions that have had so much potential to harm cancer patients and the oncology community. For example, it is generally acknowledged that the Clinical Trials Directive has had a catastrophic effect on the independent evaluation and comparison of drugs by academic clinical researchers. It has greatly reduced the amount of academic clinical research in oncology in Europe in all treatment categories (surgery, radiotherapy and systemic medicinal therapy) and in their combinations. In this case the academic community simply woke up too late, when the damage was already done,” he said.

Another example cited by Prof Eggermont was the Physical Agents (Electromagnetic Fields) Directive, which could have stopped all MRI scanning in Europe. “Eight million MRI patient examinations per year are carried out in Europe,” he said, “and the Directive set limits to occupational radiation exposure which meant that anyone working or moving near MRI equipment would breach them, thus making it possible for them to sue their employers. Luckily, in this case, oncologists and other specialists who would have been affected reacted in time – but only just. These are the kind of situations that we hope could be avoided by early input from the Academy.”

A founding group of 114 Academy members has been set up. Thirty of these members were chosen on the basis of their experience and reputation, and in turn they voted for the other members. Among the distinguished experts co-opted in the first place are Nobel prize-winners Professor Harald zur Hausen and Sir Paul Nurse; leading epidemiologist Sir Richard Peto; and the eminent Italian cancer surgeon Professor Umberto Veronesi.

Members of the ECCO Board and Policy Committee also belong to the founding group. Elected membership is a life-long distinction, and the Academy hopes to introduce new blood by electing up to 50 new members per year.

Requests to the Academy for information and advice may come from many quarters – patient organisations and health care professionals, as well as policy makers and politicians. “The ECCO Policy Committee will initially flag up issues where the Academy could make use of its expertise,” said Professor Eggermont “but at a later stage we hope that they will be able to interact directly with policymakers, for example with the European Commission about the content of future Framework Programmes for research.”

“Members are excited about what they see as a genuine intellectual challenge, responding to real needs,” said Professor Eggermont. “In the first place the Academy will put its collective intelligence to preparing a paper on what needs to be done to boost cancer research in Europe. The paper, which we hope will be produced in the next year, will look at barriers to research and how they can be addressed, as well as proposing priorities.

“We are optimistic that this new initiative will have a positive effect on all those associated with cancer, be they patients, doctors, scientists or carers, and we look forward to the time when cancer takes its rightful place in the policy agenda,” he said.

For more information:

• Presidential session 1, The unified approach: meeting the cancer challenges in the next decade, Monday 13.15-16.0 hrs CEST (Hall 1)