Pfizer Oncology to present early-stage research of investigational agents for cancer treatment

Pfizer Oncology will present data from across its portfolio, including results from long-term follow-up of Aromasin^® (exemestane tablets) in a study of early breast cancer, updated study results from a Phase 3 study of Sutent^® (sunitinib malate) in pancreatic neuroendocrine tumors (NET), and early-stage research of investigational agents PF-02341066 and figitumumab (CP-751,871) in patients with non-small cell lung cancer (NSCLC). These data, and over a dozen additional abstracts covering Pfizer agents, will be presented at the ECCO 15/ESMO 34 bi-annual meeting in Berlin, Germany from September 20 to September 24.

“Pfizer is conducting research to identify clinical benefits for targeted patient populations with investigational compounds like cMET/ALK inhibitor, while continuing to study drugs like Aromasin through their entire life cycle to ensure we provide maximum support and information to patients and healthcare providers about our cancer products,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit.

Featured Data Highlights

At the meeting, Pfizer will present new 91-month median follow-up data from the Intergroup Exemestane Study (IES) study (Abstract #5010; September 22) which is evaluating the clinical benefits of switching women to Aromasin after two to three years of tamoxifen versus continuing women on tamoxifen for a full five years of therapy. IES, a randomized, double-blind, multinational trial of postmenopausal women with hormone sensitive early breast cancer, enrolled 4,724 patients. IES is a landmark trial with the longest follow-up of endocrine treatment in the adjuvant switch setting.

New study results from an expansion cohort of a Phase 1 study evaluating the investigational agent PF-02341066 in patients with NSCLC carrying the ALK (anaplastic lymphoma kinases) fusion gene will be highlighted in the “Best of 2009” Presidential Plenary session Thursday, September 24 (Abstract #6G).³ PF-02341066 is a selective ATP-competitive small molecule inhibitor of both c-MET/HGF receptor and ALK tyrosine kinases and their oncogenic variants. PF-02341066 is the first agent in clinical development that selectively targets a unique genetic feature found in several types of cancer, echinoderm microtubule-associate protein-like 4 (EML4)-ALK translocation, present in approximately 3 - 7 percent of NSCLC patients.⁷

In addition, final results will be presented from a Phase 3 trial (Abstract #6.502, September 23), which was discontinued in January 2009 following the recommendation of an independent Data Safety Monitoring Board (DSMB) after finding no evidence of improvement in the primary endpoint of survival in patients with advanced pancreatic cancer treated with axitinib and gemcitabine, compared to gemcitabine alone.

Additional Pfizer Data Presentations

• Sunitinib vs placebo for the treatment of progressive, well-differentiated pancreatic islet cell tumors: results of a Phase 3, randomized, double-blind trial (Abstract #6.501, September 23)
• The anti-IGF-1R antibody figitumumab (CP-751,871) is active in patients with lung adenocarcinoma undergoing epithelial-to-mesenchymal transition (Abstract #1.006, September 23)