Oncology Market Leaders Must Look to Clinical Development for Future Growth



Pharma IQ
11/17/2010

Over recent years cancer drugs have moved from the traditional chemotherapies, which provided significant side effects, to more targeted therapies.

However, according to a recent Reuters report, many of these newer drugs are simply variations of existing products. These more effective, yet higher priced drugs, must now compete in the market with similar products – and this has created a slowdown in sales.

Growth within the market has been high in recent years, peaking at around 23 percent in 2006, according to IMS figures reported by the news provider. Yet, in the first nine months of 2010, this growth decreased to just 3.5 per cent.

Murray Aitken, IMS senior vice president, said that this slowdown was "unprecedented", but highlighted growth would pick up if advances were made in the clinical development of oncology drugs.

"If we had another Avastin or Herceptin (a cancer drug also sold by Roche), it would quickly change direction," he said.

Challenges for oncology clinical development

Clinical trials for cancer drugs and particularly innovative therapies, present their own challenges. With patents lasting less than a decade when products get to market, any delays can be critical.

Oncology contract research organisation Medelis and Cytel, a clinical trial specialist for the biopharmaceutical industry, recently published information regarding adaptive trial designs. 

Adaptive trials cover a whole range of topics, such as staged protocols or group sequential trials, but are designed to improve the time and success of trials.

Published in Medelis' Peer Perspectives in Oncology, the paper, by Dr. Ranganath Nayak, suggested that adaptive trial design has benefits for both sponsors and patients.

Dr. Nayak explained: "First, adaptive trials are most helpful when you do not know enough at the beginning of a trial to design it with confidence", which is of a particular benefit in phases I and II."

He added: "Second, the best way to make expensive phase III trials more successful is to do more thorough work in phases I and II."

"Getting the dose right through well-designed phase I and phase II trials is the best way to maximise success in phase III."

Concerns around the safety of human subjects within oncology trials is also high. A recent study, conducted by Kimmel Cancer Center at Jefferson, found that explosion to radiation during phase I trials was much higher than previously thought, with a toxicity risk of around 40 percent.

This is significantly higher than the ten percent rate that was previously perceived.

Richard Lawrence, assistant professor at Thomas Jefferson University, said that the findings will allow participants to better understand the risks of participating in such trials.

He added that the study also revealed a need for better consistency within the reporting and design of clinical trials.

"The nature of these trials is that it is much easier to quantify risk than potential benefits," Lawrence added.

Oncology development in China

China is also emerging as a key market for clinical development in oncology.

IMS health estimates that the oncology market in the country is currently worth over $1.5 billion (£1.1 billion), and is increasing. China itself is expected to become the third largest pharma market in the world by the end of 2011, and oncology is among the top five therapy classes in the country.

The market for oncology in China has achieved annual growth of 25 percent over the past five years.

Steven Gavel, global director of oncology at IMS, said: "Local drug manufacturers have dominated the oncology market in China in recent years, but large multinational pharmaceutical companies are gaining momentum with new, targeted therapies."

Among the companies looking to tap into this market is Bristol-Myers-Squibb, which recently signed a deal with Chinese company Simcere financial group to develop the  BMS-817378, a preclinical small molecule MET/VEGFR-2 inhibitor.

Finding a sufficiently large number of human subjects is always a challenge for those conducting clinical trials, and this is something which operations in China could address.

"This approach allows the partnership to leverage our well-recognised clinical and regulatory capabilities and our access to the vast patient pool in China,” said Dr. Peng Wang, chief scientific officer of the Simcere Pharmaceutical Group.