New Pfizer Data in Lung Cancer, Ewing's Sarcoma, Prostate Cancer and Other Difficult-to-Treat Tumor Types to Be Presented at ASCO
Researchers will present the latest data from the breadth of Pfizer's oncology portfolio, focused in four areas of discovery: anti-angiogenesis, signal transduction, immuno-oncology and cytotoxics/potentiators.
Metastatic Renal Cell Carcinoma (mRCC)
-- Updated overall survival data from a Phase 3 trial evaluating single-agent, oral SUTENT(R) (sunitinib malate) versus interferon-alfa (IFN-(alpha)) in the first-line treatment of mRCC will be presented in an oral presentation by Dr. Robert Figlin, City of Hope on Saturday, May 31.
-- Phase 2 data evaluating the anti-tumor activity of axitinib in patients with mRCC refractory to sunitinib and sorafenib, cytokines and sorafenib, or sorafenib alone will be presented by Dr. Janice P. Dutcher, New York Medical College on Saturday, May 31.
Non-small Cell Lung Cancer (NSCLC)
-- Phase 2 data evaluating the activity of the anti-IGF-1R antibody CP-751,871 in combination with paclitaxel and carboplatin in NSCLC will be presented by Dr. Daniel Karp, MD Anderson Cancer Center on Monday, June 2.
-- Phase 1 clinical trial data exploring the safety and preliminary activity of PF-299804, an irreversible pan-HER inhibitor will be presented by Dr. Pasi A. Janne, Dana Farber Cancer Center on Monday, June 2.
-- Characterization of NSCLC patients responding to anti-IGF-1R therapy will be presented by Dr. Antonio Gualberto, Pfizer Global Research and Development on Sunday, June 1.
-- Results of the safety, pharmacokinetics and preliminary activity of the anti-IGF-1R antibody CP-751,871 in sarcoma patients will be presented by Dr. Paul Haluska, Mayo Clinic on Saturday, May 31.
Prostate Cancer (mHRPC)
-- Preliminary data from a Phase 2 study evaluating the safety and tolerability of first-line SUTENT in combination with docetaxel and prednisone in patients with metastatic hormone-refractory prostate cancer will be presented by Dr. Daniel J. George, Duke University Medical Center on Saturday, May 31.
Other Pfizer Data Presentations and Celldex
Data on the following compounds will also be presented at ASCO 2008: Aromasin(R) (exemestane), Camptosar(R) (irinotecan HCl), CP-868596, PF-3512676, PF-562271 and tremelimumab.
Phase 2 data assessing the effect of EGFRvIII-targeted vaccine (CDX-110) on immune response and time to progression when given with simultaneous standard and continuous temozolomide in patients with Glioblastoma, a form of brain cancer will be presented by Dr. John Sampson, Duke University on Monday, June 2. Pfizer has signed an exclusive license agreement with Celldex Therapeutics to develop and commercialize CDX-110.
About SUTENT(R) (sunitinib malate)
SUTENT is an oral multi-kinase inhibitor approved for the treatment of advanced renal cell carcinoma (RCC) and gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
SUTENT works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two important sunitinib malate targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are expressed by many types of solid tumors, and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.
Important SUTENT(R) (sunitinib malate) Safety Information
Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on SUTENT.
Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure.
Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. CBCs with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.
The most common adverse reactions in mRCC and GIST clinical trials were fatigue, asthenia, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspensia, abdominal pain, constipation, hypertension, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia and bleeding.
For more information on SUTENT and Pfizer Oncology, including full prescribing information for SUTENT (sunitinib malate), please visit www.pfizer.com.
Vanessa Aristide, 212-733-3784
Jennifer Davis, 212-733-0717
Posted: May 2008