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Pfizer Oncology today announced that important data from its lung cancer and renal cell carcinoma (RCC) portfolios will be presented at the upcoming European Society for Medical Oncology (ESMO) Congress in Vienna, Austria, September 28 – October 2, 2012.
“We believe that the clinical trial results to be shared at ESMO 2012 substantially enhance our knowledge of both marketed and investigational therapies from our lung and kidney cancer portfolios,” said Mace Rothenberg, MD, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit. “We are especially pleased to be able to share, for the first time, detailed results of PROFILE 1007, a randomized trial comparing XALKORI to standard chemotherapy in patients with recurrent, ALK-positive non-small cell lung cancer (NSCLC). These results, which will be presented at the Presidential Symposium, reinforce the value of Pfizer’s precision medicine approach to drug development, and demonstrate the benefit that targeted, efficient and science-driven cancer drug development can have on patient outcomes.”
Treating Lung Cancer Through a Targeted Approach
Data highlights relating to Pfizer’s lung cancer portfolio include:
Phase 3 randomized study of crizotinib versus pemetrexed or docetaxel chemotherapy in advanced, ALK-positive NSCLC (PROFILE 1007) (Presidential Symposium, Abstract #LBA1, September 30, 16:00-18:00) 1
Updated results of a global Phase 2 study with crizotinib in advanced ALK-positive NSCLC (Poster Discussion, Abstract #1230PD, September 30, 12:45-14:15) 2
Clinical activity of crizotinib in patients with advanced NSCLC harboring ROS1 gene rearrangement (Poster Discussion, Abstract #1191PD, September 30, 12:45-14:15) 3
Updated data will be presented on dacomitinib, an investigational, irreversible pan-HER tyrosine kinase inhibitor (TKI), for first-line treatment of EGFR-mutant, HER2-mutant or amplified lung cancers (Oral Presentation, Abstract #1228O, September 30, 9:00-11:00).
4 Additionally, data from a Phase 1 trial of dacomitinib in combination with XALKORI (crizotinib) in previously treated advanced NSCLC will be presented (Poster Presentation, Abstract #1290P, September 29, 13:00-14:00).
5Pfizer Oncology Leadership in Renal Cell Carcinoma
Pfizer Oncology is committed to contributing to the science of advanced RCC and continues to support a number of studies evaluating established and novel compounds for the disease. Pfizer will present data from new and ongoing analyses of its RCC clinical trial program at ESMO 2012, broadening clinical understanding of INLYTA
® (axitinib), SUTENT
® (sunitinib malate) and TORISEL
® (temsirolimus) across the spectrum of renal cancer.
INLYTA is an oral kinase inhibitor designed to inhibit tyrosine kinases including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3. Data presentations for INLYTA include:
Clinic and home blood pressure measurements are reliable for guiding therapy in patients with metastatic RCC receiving axitinib as first-line therapy (Poster Presentation, Abstract #811P, September 29, 13:00-14:00) 6
Axitinib vs sorafenib for advanced RCC: Phase 3 overall survival results and analysis of prognostic factors (Poster Discussion, Abstract #793PD, October 1, 13:00-14:00) 7
As part of the continued evaluation of SUTENT, data to be presented at the meeting include:
Comparative assessment of sunitinib-associated adverse events (AEs) as potential biomarkers of efficacy in metastatic mRCC (Oral Presentation, Abstract #785O, October 1, 14:00-15:00) 8
Sunitinib dosing schedule and data collection timepoints: impact on quality of life outcomes in metastatic RCC (Poster Presentation, Abstract #815P, September 29, 13:00-14:00) 9
Late breaking data will be presented in oral sessions from two randomized Phase 3 studies evaluating TORISEL in patients with advanced RCC at different stages of disease, including results from the INTORSECT trial in previously treated patients compared with sorafenib. (Proffered Papers Session, Abstract #LBA22_PR, October 1, 14:00-15:50).
10 Pfizer will also present results from the INTORACT trial evaluating TORISEL in combination with bevacizumab in treatment-naïve patients (Proffered Papers Session, Abstract #LBA21_PR, October 1, 14:00-15:50).
Pfizer previously announced that the INTORSECT and INTORACT trials did not meet their primary endpoints in May 2012 and August 2012, respectively.