Advertisement
LONDON and PHILADELPHIA, May 31 /PRNewswire-USNewswire/ -- GlaxoSmithKline today announced the results of two Phase II trials demonstrating the potential for pazopanib, an oral, investigational angiogenesis inhibitor, as a treatment for non-small cell lung cancer (NSCLC),(1) the most common form of lung cancer,(2) and renal cell carcinoma (RCC).(3) The data were presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Pazopanib is not approved in any market for any indication at this time.
Advertisement
Pazopanib targets vascular endothelial growth factor receptor (VEGFR), platelet derived growth factor receptor (PDGFR) and c-kit, key proteins that help with the growth of new blood vessels in the body.(4) This process, known as angiogenesis, plays a critical role in the growth and spread of tumors(5).
"These very promising results highlight the potential of pazopanib as a future treatment option across multiple forms of cancer," said Thierry Le Chevalier, M.D., Vice President, Oncology Medicine Development Center, GSK. "GSK is conducting a broad research program for pazopanib in a number of tumor types and this demonstrates our ongoing commitment to the development of innovative and effective treatments for patients with cancer."
Pazopanib and Non-Small Cell Lung Cancer: abstract 7557 (1)
DATA PRESENTATION: SUNDAY, JUNE 1, 2008, 11:00 AM - 12:00 PM (CDT)
This open-label, multi-center, Phase II study was designed to assess the activity of pazopanib when given to 35 treatment-naive patients with stage I-II NSCLC prior to surgery. Pre- and post- treatment high resolution computed tomography (HRCT) scans measuring tumor size showed that 30 patients (86 percent) had experienced a tumor volume reduction. Overall, patients experienced changes in tumor size ranging from a reduction of 86 percent to an increase of 17 percent.(1)
After an initial biopsy, 35 eligible patients had received 800 mg of pazopanib orally, once daily for two-six weeks, followed by a treatment free period of seven days prior to scheduled surgery to allow the administered drug to be eliminated from the body. The median duration of pazopanib therapy was 16 days.(1)
Grade 3 toxicities were seen in five patients while participating in study. These toxicities included elevated liver enzymes (2), hypertension (1), shortness of breath (1), pneumonia (1), urinary tract infection (1), reduced white blood cell count (1) potassium increase (1) and rash (1). One Grade 4 toxicity of a pulmonary embolus was seen in a patient in relation to surgery, 18 days after finishing pazopanib treatment. One patient discontinued treatment due to adverse events. Twelve patients required adjustment or initiation of antihypertensive medication during the study.(1)
Eight study centers participated in the trial in multiple countries including the US, Israel, and Spain. Based on these promising data, further studies with pazopanib in multiple stages of NSCLC are planned.
Pazopanib and Renal Cell Carcinoma: abstract 5046 (3)
DATA PRESENTATION: SUNDAY, JUNE 1, 2008, 11:00 AM - 12:00 PM (CDT)
This Phase II study was in 225 patients with advanced or metastatic RCC. The primary endpoint was to evaluate overall response rate according to RECIST criteria (Response Evaluation Criteria in Solid Tumors) - published guidelines that define when cancer patients improve. The study was originally designed as a randomized discontinuation trial. Patients received 800 mg of pazopanib once daily orally and response to treatment was measured at 12 weeks. Based on the interim analysis at week 12, 38 percent of p
