(1888PressRelease)
June 02, 2009 - Study findings demonstrated that the median time without tumor growth or death (progression free survival or PFS) in the pazopanib treated group was 9.2 months compared to 4.2 months in the placebo group. When specific patient groups were evaluated, those with no prior drug treatment experienced 11.1 months of median PFS with pazopanib versus 2.8 months with placebo.1 Patients who had previously received cytokine-based treatment showed 7.4 months of median PFS with pazopanib versus 4.2 months with placebo.1 These results were featured in an oral presentation at the annual American Society for Clinical Oncology (ASCO) meeting in Orlando, Florida.2
“The study shows that pazopanib significantly improved PFS for patients regardless of whether or not they had prior therapy. While there have been many treatment advances for patients with advanced kidney cancer, there is still a need for medicines that are effective and well-tolerated,”said Dr. Cora N. Sternberg, Department of Medical Oncology, San Camillo and ForlaniniHospitals, Rome, Italy. “Additionally, patients did not experience a significant decline in health-related quality of life with no significant differences between pazopanib and placebo.”
The results are based on a global, double-blind, Phase III trial of 435 patients with advanced kidney cancer (renal cell carcinoma) who had either received no prior drug treatment or had received prior cytokine-based treatment.1 Patients were randomly assigned on a 2-to-1 basis to receive either pazopanib or placebo.1 Pazopanib reduced the risk of disease progression or death by 54% (hazard ratio = 0.46 with 95% confidence interval 0.34 to 0.62; P3%) were diarrhea (4%), hypertension (4%), and asthenia (3%). The most common laboratory abnormalities (incidence ≥50%) were elevated levels of liver enzymes known as transaminase, with elevated ALT as the most common grade 3/4 event (12%).1 Investigator-reported serious adverse events included liver-related events (3%), arterial thrombotic events (3%) and hemorrhage (3%).4In this study, approximately 4% of patients on treatment compared to 3% of patients on placebo had a fatal event. Investigators attributed death due to study drug in approximately 1.4% of patients in the treatment arm.1 Some of these adverse events/serious adverse events have been reported with this class of agents.5
Pazopanib is an oral medicine that prevents the growth of new blood vessels to tumors.6 The growth of new blood vessels is a process called angiogenesis.7 All solid tumors need blood vessels to survive, and by stopping or slowing this process, medicines in this category may halt the progression of tumor growth.7
In December 2008, GSK submitted a GSK new drug application (NDA) to the U.S. Food and Drug Administration (FDA) and, in early 2009, a European marketing authorization application (MAA) to the European Medicines Agency (EMEA) for pazopanib for the treatment of advanced renal cell carcinoma (RCC) based on these data. The submission was recently accepted by the FDA. Pazopanib is not yet approved in any country for any indication at this time.
“We’re extremely pleased to see the progress in developing pazopanib for advanced kidney cancer, but this represents just one type of cancer in need of new treatments. Our global studies using pazopanib are designed to find new ways to use a proven mechanism to fight a diverse group of cancers,” said Paolo Paoletti, Senior Vice President, R&D Oncology Unit. “This further demonstrates our efforts to discover new medicines that provide tangible clinical benefits for patients.”
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
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