Sutent® cost effetctive advantage predicted in treating patients with metastatic renal cell carcinoma

STOCKHOLM, 15 September 2008 - Results from an international study presented today at the European Society for Medical Oncology (ESMO) predict that sunitinib (SUTENT®) is cost effective as a first-line therapy for patients with metastatic renal cell carcinoma (mRCC) (1,2,3).

The economic model, which was analysed in the context of three healthcare systems - Sweden1, Spain2 and the US3 - predicts better outcomes with sunitinib, in terms of life years, progression-free life years and quality-adjusted life years (QALYs), compared with bevacizumab + interferon-alpha (IFN-α), sorafenib and temsirolimus. In addition, sunitinib was found to be cost saving when compared with bevacizumab + IFN-α and temsirolimus.

Quality of life data also highlight that treatment with sunitinib is consistently associated with better health-related quality of life compared with IFN-α treatment in patients with mRCC. This is supported by findings reported across the EU, from the USA, Brazil, Russia, Australia and Canada (p<0.05) (4).

Dr Ulrika Harmenberg, Karolinska Institute, Stockholm, Sweden, commented: "These new data provide additional evidence for the benefits of sunitinib in patients with this rare and difficult-to-treat cancer. Added to the results from a landmark study presented at ASCO earlier this year, that demonstrate that sunitinib extends overall survival beyond two years, this research supports the role of sunitinib as the reference standard of care in mRCC, and predicts its cost effectiveness versus other treatments."

Around 63,000 people are diagnosed with kidney cancer in Europe each year, which accounts for three per cent of all cancer cases (5). Until recently treatment options were limited, but with the availability of sunitinib there is now an important advance in the management of this condition, with the demonstration of an overall survival of more than two years (objective response rate (ORR) of 47% (95% CI: 42.52) for sunitinib versus 12% (95% CI: 9.16) for INF-α (p< 0.000001) (6).

Sunitinib, an oral therapy, was approved in Europe as a first line treatment for mRCC in January 2007.  It is a novel addition to a new class of "multi-targeted" anti-cancer drugs.  It targets the tumour with a dual action strategy, by stopping the cancer cells from multiplying and cutting off the tumour's blood supply. 

Sunitinib, which is also indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate, is being investigated for a number of other tumour types including breast and colorectal cancers.

Notes to Editors:

About SUTENT:
SUTENT is an oral, multi-targeted cancer therapy that selectively targets multiple receptor tyrosine kinases (RTKs) involved in tumour growth, angiogenesis and the progression of cancer.  By inhibiting these RTKs, SUTENT targets multiple signalling pathways resulting in a dual action anti-proliferative and anti-angiogenic effect, which may lead to tumour regression and disease stabilization.
The recommended starting dose for SUTENT is 50mg once daily for four weeks followed by two weeks off. The dose can be modified in 12.5mg increments not to exceed 75mg or decrease below 25mg. SUTENT is available in 12.5mg, 25mg and 50mg capsules. Please refer to the Summary of Product Characteristics (SPC) for additional dosing recommendations regarding co-administration with cytochrome P450 3A4 inducers or inhibitors.
Adverse events (AEs) were generally mild to moderate. Most adverse events were reversible, and generally did not result in discontinuation. In clinical trials, the most common treatment related adverse events (>20%) included fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis, dyspepsia and vomiting; skin discoloration; dysgeusia (loss of taste); and anorexia. Fatigue, hypertension and neutropenia were the most common grade 3 treatment related adverse events. Increased lipase (2%) was the most common grade 4 treatment related adverse event. Hepatitis and hepatic failure occurred in <1% of patients and prolonged QT interval events occurred in less than 0.1%.
The most important treatment related serious adverse events associated with SUTENT treatment of solid tumour patients were pulmonary embolism (1%), thrombocytopenia (1%), tumour haemorrhage (0.9%), febrile neutropenia (0.4%), and hypertension (0.4%). Patients should be screened for hypertension and appropriately controlled with medical management. Temporary suspension of SUTENT is recommended in patients with severe hypertension that is not controlled with medical management (7).
Developed by Pfizer, SUTENT is being studied alone and in combination with other medicines as a potential treatment for a number of other solid tumours, including breast, lung, prostate and colorectal cancers. 

About Pfizer:
Pfizer Inc, the world's largest research-based pharmaceutical company, discovers, develops, manufactures and markets prescription medicines in 10 therapeutic areas including oncology, cardiovascular, pain, neuroscience and infectious diseases, including HIV/AIDS.  Pfizer is also the world's largest animal health company.
Pfizer conducts more biomedical research than any other organisation, and has 12,000 professionals working in four major R&D sites worldwide, including its European R&D headquarters at Sandwich, UK.

About Pfizer Oncology:
Pfizer Oncology is committed to the discovery, investigation and development of treatments and currently has 22 innovative compounds in clinical development across four platforms. 
 
By leveraging the strength of our resources and scientific talent, Pfizer Oncology strives to discover and develop novel treatment options to improve the outlook for oncology patients.  Pfizer currently devotes more than 22 percent of its total R&D budget to the field of oncology, investing annually in worldwide research initiatives.  We also partner with healthcare providers, governments and local communities around the world to provide better quality healthcare and health system support.

References

  1. U Munir, A Benedict, B Borgman, R Sandin, A Ullèn, U Harmenberg, P Sandström: Cost effectiveness and cost utility analysis of sunitinib (SU) vs sorafenib (SFN) and bevacizumab plus interferon-alfa (BEV/IFN) as first-line treatment for metastatic renal cell carcinoma (mRCC) - adaptation for the Swedish Health Service / Abstract 1146S ESMO 2008
  2. S. Diaz, E Calvo Aller, P Maroto, J Puente, M López-Brea, D Castellano: Cost effectiveness and cost utility analysis of sunitinib (SU) vs sorafenib (SFN) and bevacizumab plus interferon-alfa (BEV/IFN) as first-line treatment for metastatic renal cell carcinoma (mRCC) in Spain / Abstract: 931 ESMO 2008
  3. Ágnes Benedict, Claudie Charbonneau, Sindy T. Kim, Sylvie Nègrier: Cost effectiveness of sunitinib (SU), sorafenib (SFN), temsirolimus (TMS), and bevacizumab plus interferon -alfa (BEV/IFN) as first-line therapy for metastatic renal cell carcinoma (mRCC) - an indirect comparison / Abstract: 1034 ESMO 2008
  4. Cella D et al. Health-related quality of life (HRQOL) in metastatic renal cell carcinoma (mRCC) patients receiving sunitinib (SU) or interferon (IFN)-alfa in a randomized phase III trial: udated geographic analysis. Abstract 651 ESMO 2008
  5. UK kidney cancer incidence statistics. http://info.cancerresearchuk.org/cancerstats/types/kidney/incidence/#source8.
  6. Figlin RA, Hutson TE, Tomczak R, et al. Overall survival with sunitinib verus interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC). J Clin Oncol 2008;26(No 15S):abstr 5024
  7. Sutent Summary of Product Characteristics. Pfizer Ltd