PRESS RELEASE: Novel therapies a welcome addition to renal cancer treatment options

Novel therapies a welcome addition to renal cancer treatment options

London Wednesday December 19 2007- Renal cancer is a disease which has traditionally been poorly served in terms of efficacious drug therapies. However, in the last two years some degree of hope for renal cancer patients has emerged in the form of three new drugs which have entered the renal cancer market. According to a new report* by independent market analyst Datamonitor, the new drugs are experiencing a high level of uptake in the renal cancer market. Nevertheless, there remains a high level of unmet need in this disease: the prognosis for patients with advanced stage renal cancer remains bleak, and 13,000 people will still die from renal this year in the US alone. This in turn provides a substantial opportunity for drug developers and the late stage development pipeline boasts several promising drugs.

Bleak prognosis for advanced stage RCC patients

In 2007, an estimated 86,000 people in the seven major markets** will be diagnosed with renal cell carcinoma (RCC), the most common form of renal cancer. RCC accounts for around 85% of renal cancer cases overall.

Around 75–80% of RCC patients will be diagnosed with Stage I–III disease, where the cancer has spread no further than one lymph node. Surgery, usually involving removal of the entire affected kidney, is the most commonly used type of treatment for these patients. In the majority of cases, this approach results in cure. However, a significant proportion of patients with Stage I–III RCC suffer relapse after surgery. Most of these patients relapse with advanced disease. 

The remaining 20–25% of patients present with advanced (Stage IV) RCC. This means that the disease has already spread to other parts of the body or to more than one lymph node by the time the cancer is diagnosed, says Datamonitor oncology analyst Dr. Tom Gray. "The prognosis for these patients is bleak. Surgery is not curative, and survival is typically limited to between one to two years. 

"In the US alone, there are predicted to be around 13,000 deaths from renal cancer in 2007," he says.

Recent drug approvals provide much-needed extra therapeutic options

Until relatively recently, treatment options for patients with Stage IV RCC were very limited. The only two drugs available to these patients were interferon alfa and interleukin-2, both of which are classified as cytokines – proteins that modulate the immune system. These two agents are both associated with very low response rates and considerable toxicity and thus, the demand for new drugs in this therapy area has been high. 

Since 2005, three novel targeted therapies have been approved for RCC in the US and EU, providing much-needed additional treatment options for patients with advanced stage RCC. In clinical trials, these drugs have shown superior efficacy and tolerability compared to the traditionally used cytokine therapies.
 
Two of these drugs – Pfizer's Sutent (sunitinib) and Bayer/Onyx's Nexavar (sorafenib) – target receptors specific to the tumor, inhibiting tumor angiogenesis (growth of new blood vessels from the tumor). In this way, the tumor is starved of oxygen and nutrients and is prevented from growing. The third recently approved drug is Wyeth's Torisel (temsirolimus), which inhibits a protein that plays an important role in tumor growth, Dr. Gray says. "In addition, a fourth targeted therapy, Genentech/Roche's Avastin (bevacizumab), is being used to treat RCC in the US, and is expected to be approved in the EU in the near future. Like Sutent and Nexavar, this drug also inhibits angiogenesis."
 
Datamonitor physician survey shows swift uptake of targeted therapies
 
Based on a survey of 180 physicians, Datamonitor found that targeted therapies have experienced considerable uptake for RCC and are the predominant therapy class in most of the seven major pharmaceutical markets**.
 
To date, Sutent is the drug showing the most promising efficacy in previously untreated RCC patients. In these patients, the drug increases progression-free survival by six months on average compared to interferon alfa. This has driven substantial uptake of the drug, making it the most prescribed first-line therapy in most of the seven major pharmaceutical markets**.
 
Datamonitor found that Nexavar is the most commonly prescribed second-line therapy for RCC. However, there is a lack of evidence showing that this drug is efficacious as a second-line therapy in patients who initially received Sutent. Given that many second-line patients will have received Sutent as their initial therapy, and considering the lack of data for second-line regimens in these patients, this segment of the renal cancer market is set to become increasingly contested.
 
Substantial unmet needs persist despite recent advances in RCC
 
While the newly available therapies in RCC have been a welcome step forward in the treatment of the disease, there is still much scope left for improving treatment outcomes. Sutent and Nexavar both improve progression-free survival, yet only Torisel has been shown to prolong the length of overall survival A further area of considerable unmet need is the lack of efficacious adjuvant regimens to reduce the risk of relapse in surgically treated early-stage disease, Dr. Gray says.
 
"According to the RCC experts interviewed by Datamonitor in the course of its research, further progress with the treatment of RCC is likely to involve combinations of different therapies.
 
"In addition to the targeted therapies currently available, there are several promising targeted agents in the late-phase pipeline, providing a multitude of possibilities for potential future regimens."
 
Ends
 
Notes for editors
*Stakeholder Insight: Renal Cancer - Targeted therapies rapidly take hold of market
**The seven major pharmaceutical markets are the US, Japan, France, Germany, Italy, Spain and UK.
 
Datamonitor's report Stakeholder Insight: Renal Cancer - Targeted therapies rapidly take hold of market explores key issues in the renal cancer market including forecast epidemiology data, current diagnosis and treatment patterns, treatment outcomes and prescribing influences in the 7 major pharmaceutical markets. Particular focus on renal-cell carcinoma (RCC).
 
Dr. Tom Gray, Datamonitor oncology analyst and report author is available for comment.
 
To arrange an interview or for further details regarding the report contact Matthew Dick in the Datamonitor Press Office on + 44 20 7551 9387, or email mdick@datamonitor.com [1] .
 
For US, please call Suzanna Eygabroat on +1 585-374-6326 x17
For Asia-Pacific, please call Denis Mason on +61 2 8705 6903.
 
Datamonitor is the world's leading provider of online data, analytic and forecasting platforms for key vertical sectors. We help our clients, 5,000 of the world's leading companies profit from better, more timely decisions. Through our proprietary databases and wealth of expertise, we provide clients with unbiased expert analysis and in-depth forecasts for seven industry sectors: Automotive & Logistics, Consumer Markets, Energy, Financial Services, Healthcare, Retail and Technology. Datamonitor maintains its headquarters in London and has regional offices in Frankfurt, New York, San Francisco and Sydney. See www.datamonitor.com [2] for further details.