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Renal Cell Carcinoma Drug Discoveries:What the future holds

This is a very exciting time in the treatment of renal cell carcinoma (RCC)...

With the advent of the new targeted therapies there has been a complete shift in paradigm. Treatment options for patients with advanced disease have improved dramatically; until recently there was limited choice and therapies were poorly tolerated, with relatively low response rates. Patients now face multiple options with improved safety and efficacy, and there are plenty of further therapies in the pipeline. The overall prognosis has changed for these patients and survival is now much longer.

While the RCC market has traditionally constituted a relatively small segment of the oncology market, it has more recently attracted considerable R&D investment from big pharma, biotechnology companies and specialty pharma. Older immunotherapy regimens have now been replaced as the standard of care by the newer targeted therapies launched in recent years, namely Pfizer’s Sutent (sunitinib), Bayer/Onyx’ Nexavar (sorafenib), Roche’s Avastin (bevacizumab) and Pfizer’s Torisel (temsirolimus). Since the launch of these agents in 2005/2006, the RCC market has become a rapidly-growing segment, with almost US$2.2 billion spent on branded drugs in 2008.

Significant opportunities still exist for products to expand within this marketplace. A large percentage of patients are not currently treated with drug therapies and are not cured by surgery alone; patients with localised and locally-advanced disease represent a significant patient population that may be suitable for adjuvant therapy with targeted therapies. Established agents such as Sutent, Nexavar and Avastin are being investigated in the adjuvant setting, along with new therapies including Wilex’ Rencarex (girentuximab), currently in Phase III trials. In addition, many patients do not respond to current therapies, and more effective product introductions and greater use of combination therapies will address this clinical need for patients with metastatic RCC.

This report forecasts that sales of RCC treatments will increase substantially to almost US$6.5 billion in 2015, with a compound annual growth rate of 16.8%

The number of patients by value in the US, Europe (top five countries) and Japan will increase by 35.7% by 2015 (from around 613,000 in 2008 to approximately 832,000 in 2015). We estimate that approximately 18% of the RCC patient population currently receives drug therapy. By 2015, we expect a higher percentage of patients to receive treatment, reflecting an increase in the number of treatment options, improvements in drug efficacy and the use of drug therapy earlier in the course of the disease.

Why this sector is important: positive drivers

• Better US diagnosis rates: Over 30% of RCC cases in the US are diagnosed at Stages III or IV, an area of high unmet clinical need.

• The need for improved efficacy: Around 50% of early-stage patients are not cured by surgery and around 80% of patients with advanced disease fail to respond to approved therapies.

• Alternative drug administration: Current immunotherapy requires frequent administration, intramuscularly or intravenously, and the advent of longer-acting oral products will be welcomed by clinicians and patients alike.

• More therapy choice: New treatments will gain broader indications in the treatment of RCC eg in the adjuvant or neoadjuvant setting at earlier stages of disease due to their proven track record of safety and efficacy.

• Improved funding: Increased accessibility to cancer drugs via Medicare reform, Medicaid coverage and the European and Japanese regulatory health authorities.

The shape of the RCC sector in 2008...

In 2008, the RCC market was driven by sales of new targeted agents, namely Pfizer’s Sutent (sunitinib) and Bayer/Onyx’ Nexavar (sorafenib) as the clear leaders, followed by Roche’s Avastin (bevacizumab) and Pfizer’s Torisel (temsirolimus). Together these therapies secured sales of almost US$1.8 billion. Just five major players competed for a share of the RCC market. The introduction of targeted therapies in 2005/2006 has seen Pfizer and Bayer/Onyx come from nowhere to now dominate with a combined 67% market share.

...and in 2015
The total RCC sales for branded products will increase substantially from almost US$2.2 billion in 2008, to almost US$6.5 billion in 2015, with a compound annual growth rate of 16.8%. Sales will be driven by the new targeted therapies which will account for sales of around US$6.1 billion in 2015, with Pfizer’s Sutent, Bayer/Onyx’ Nexavar, Roche’s Avastin and GlaxoSmithKline’s Armala/Votrient responsible for approximately US$4.5 billion of this. There are four current Phase III products which have the potential to reach the market by 2015, including Wilex’ Rencarex.

About the Author
This report has been researched and written by senior Espicom pharmaceutical analyst Sue Viney. For over 10 years she has played a pivotal role in tracking trends in drug development and corporate performance. In addition to this report she has produced detailed product analysis in the CNS, Breast/Lung/Colorectal Cancer/Prostate and rheumatoid Arthritis sectors