PCG Clinical Services Trends and Challenges in cancer drug development

Published on May 3rd, 2017 | by PCG

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Trends & challenges in cancer drug development (Part 1)

Improving cancer treatments is a priority for many drug developers, academic researchers and funding bodies. This has led to a wealth of innovative new therapies and increased survival rates, but there are still types of cancers with massive unmet needs. New breakthroughs will possibly add further to the complexities and challenges within drug development to meet the increased need for and goal of precision medicine. Such challenges and complexities could include high costs, competition for eligible patients in certain disease settings, safety complexities and lack of understanding about disease biology. Here we discuss some of the current trends and future considerations for oncology therapeutics. In part 2 of this article series, we will consider how pharma companies can reduce unnecessary costs and optimise their clinical research through working with an effective clinical research organisation.

 Text by:  PCG Clinical Services team with contributions from Antaros Medical AB

 

Introduction

The healthcare burden of cancer is increasing worldwide. It has been estimated that there were 14.1 million new diagnoses in 2012 and 8.8 million deaths from cancer in 20151. By 2030, the incidence is expected to increase by almost 70 % to 23.6 million new cases per year. Although the number of oncology drugs available is increasing, there are still types of cancers with massive unmet needs. The combined global cost of oncology drugs and supportive treatments was $83 billion in 2015 and is projected to reach $190 billion by 20222. With the increase in cancer incidence and thereby rapidly escalating costs, improving oncology diagnostics and therapeutics is a high priority for both patients and for society as a whole.

 Accordingly, there has been a great deal of innovation in oncology research and development, enhanced by simultaneous advances in digitalised healthcare, technology and the availability of and ability to process huge data sets. Some exciting new tools for precise cancer diagnostics are in development, such as liquid biopsies, biomarker-based disease prediction, innovative imaging methodologies and tumour staging based on automated disease modelling. In the future, more precise diagnostics might allow tumours to be detected at such early stages that chemotherapies will no longer be required. However, in the meantime, pharmaceutical companies, academia and non-governmental organisations globally will jointly be focusing on improving anti-cancer therapies.

 

Trends in finding effective treatments

 Some revolutionary anti-cancer treatments have emerged over the last couple of decades, including immunotherapies. More drugs have been approved within oncology than in any other therapy area since 20003, and there were 70 new oncology approvals between 2010-2015, for use in over 20 different tumour types2. To put this into context, there were only 63 oncology drugs available in total on the UK market, prior to the year 20004. This upsurge of new approvals and oncology drugs coming to market has been helped by regulatory initiatives such as the FDA’s Breakthrough Therapy Designation and Accelerated Approval, and the EMA’s Priority Medicine (PRIME) scheme5. In 2016, four new cancer drugs were approved by the FDA, and all were accelerated approvals. Despite slightly fewer approvals in 20165, the rise in new oncology therapies is expected to continue over the coming years3.

 

Targeted therapies

Targeted therapies have attracted much interest within oncology R&D: it was recently estimated that these account for 87 % of oncology drugs in late phase clinical development2. Targeted therapies include small molecules or monoclonal antibodies that specifically target selected pathways of the tumour cells, as well as antibody-drug conjugates (ADCs) that bind to a particular cell surface protein on tumour cells via the antibody, in order to deliver the linked drug into the cell. Targeting the therapy specifically to cancer cells not only reduces harmful side effects for healthy cells, but can also achieve better clinical effect. Several targeted therapies have been approved over the last decade6 and are helping many patients. Many more therapies are now in clinical trials6, 7.

 

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