Targeted Cancer Drugs
The Launch Landscape to 2018

As the cancer therapy market evolves, interest is growing in novel approaches that may supersede the current portfolio. In the short term, the market will be dominated by established therapeutic approaches, but the question is – “What next?”

A sign of things to come?

The end of 2011 saw the US approval of two new molecularly-targeted cancer drugs, alongside companion diagnostic tests that identify the patients most likely to benefit from treatment. Pfizer's Xalkori (crizotinib) and Roche's Zelboraf (vemurafenib) were both approved following a priority review, highlighting the importance that the FDA has placed on hastening the passage of these therapies to market. These approvals reflect the trend of treating cancers based on their molecular and genetic characteristics, rather than their location within the body.

Such developments have long been heralded as marking the future of cancer therapies and the benefits to patients, clinicians and health payers is clear – but are these approvals the benchmark for future developments?

With sales of many blockbuster drugs being cannibalised by generic competitors, pharmaceutical and biotechnology companies are populating their pipelines with candidates directed at novel targets, enhancing development and commercialisation potential. The opportunities for small and medium-sized companies is increasing as the dynamic of the market changes.

This new report provides a complete assessment of the targeted cancer therapy landscape

Packed with statistics, timelines and sector share comparisons, this report examines the current market for targeted cancer drugs, and provides an overview of both products and players into 2018. Looking ahead, the report identifies 79 new candidates that are currently under a minimum of Phase II development for solid tumours and provides a timeline detailing estimated launch dates to 2018. There is a review of the molecular targets on which industry attention is focused, and the companies involved in the development and commercialisation of the products directed against these targets. Finally, each product is considered individually in terms of its mode of action, current developmental status, clinical data, risks associated with development, developer and potential competition within the marketplace.

The global cancer market is changing fundamentally as broad spectrum drugs are superseded by advanced targeted therapies

Current therapeutic approaches for targeted agents will dominate...
With the success of products directed against established targets, such as ErbB (HER) and VEGF, the search continues for new and improved agents within these groups. For example, Roche is capitalising on the success of its HER2 inhibitor, Herceptin (trastuzumab), with the development of an antibody-drug conjugate, trastuzumab emtansine, which consists of the monoclonal antibody, trastuzumab, linked to the antimicrotubule agent, DM1. Pfizer has developed a multi-kinase inhibitor, dacomitinib, that targets HER1, 2 and 4, and has shown superiority to Roche's Tarceva (erlotinib) in extending progression-free survival in advanced non-small cell lung cancer patients. In addition, a variety of smallmolecule kinase inhibitors that target multiple components of the VEGF pathway and/or other angiogenic pathways are progressing through clinical trials.

...but will candidates directed at novel targets gain ground?
By 2018, Espicom expects that these new developmental candidates will account for 50% of targeted agents on the market by number. Among the pathways - and the products being developed - examined in the report are:

• The Met pathway plays an important role in the development of cancer, so interfering with Met signalling would seem to be a promising therapeutic approach and a number of targeted agents are under development.
• There is significant research interest in the PI3k/Akt signalling pathway which has shown an impressive improvement in overall survival.
• A phosphatidylserine-targeting monoclonal antibody has the potential to be effective against a wide range of solid tumours.
• Heat shock proteins are over-expressed in a wide range of human cancers and have been considered a promising target for cancer therapy, although the early Hsp inhibitors were dogged by drug-related toxicities. Those now progressing through clinical trials appear to show greater efficacy and less off-target activity.

How will the competitive landscape be affected?

A number of the larger players will continue to dominate the marketplace into 2018 with Roche, Takeda, Eli Lilly and BMS all estimated to have achieved five or more launches. However, significant opportunities exist for many smaller innovative pharma companies and biotechs, which by their very nature are proficient and well-suited to product development in niche markets.

Questions answered by the report

• How many products are profiled treating lung, breast and colorectal cancer?
• Which developmental pathways are much fancied to provide significant clinical advances and which companies are involved?
• BMS, Eli Lilly, Roche, and Takeda all have five or more products in latestage expected to launch – what are they, what do they target and when are they expected?
• What are the prospects for Teva Pharmaceutical Industries’ oncology portfolio?
• Emerging opportunities: with whom are the smaller companies working and how many have yet to secure development/marketing collaborations?

About the Author: This report has been written by Sue Viney, a senior writer on Espicom’s oncology analysis team. Sue has been evaluating companies, products and drugs in research for 12 years.