Pfizer to present PF-299 and crizotinib clinical trial data on ALK at WCLC 2011

Pfizer Inc. will present early and mid-stage data from its lung cancer portfolio, including PF-00299804 (PF-299) an investigational, oral, pan-HER inhibitor; and crizotinib, an investigational, oral, first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK, at the International Association for the Study of Lung Cancer's (IASLC) 14^th World Conference on Lung Cancer (WCLC), July 3-7 in Amsterdam, The Netherlands.

"While lung cancer remains a difficult-to-treat disease, we're learning more about how therapies like crizotinib and PF-299 may be able to specifically target ALK or the HER pathway, respectively, and how this may lead to more rationally selected and personalized therapy," said Maurizio Voi, MD, Thoracic Tumor Strategy Lead, Pfizer Oncology. "Data being presented show survival outcomes for PF-299 and crizotinib, as well as quality-of-life or patient-reported outcomes after treatment for patients with non small cell lung cancer, which represent important considerations in determining the best treatment option for these patients."

First Presentation of PF-299 Preliminary Overall Survival Data

Pfizer will present, for the first time, preliminary overall survival data from a Phase 2 study evaluating PF-299 vs erlotinib in patients with advanced non-small cell lung cancer (NSCLC) after progression on at least one chemotherapy regimen (oral presentation, Abstract #745, Monday, July 4).

Pfizer also will present patient-reported outcomes (PRO) from clinical trials of PF-299 in refractory and second-/third-line NSCLC, which provide a better understanding of the patient's perspective of the burden of adverse events associated with treatment and how it may change over time.

• Gastrointestinal toxicity of the pan-HER tyrosine kinase inhibitor (TKI) PF299804: Assessment by patient-reported outcomes in second-/third-line and refractory NSCLC (poster session, Abstract #957, Wednesday, July 6)
• Dermatologic adverse events of the pan-HER tyrosine kinase inhibitor (TKI) PF299804: Assessment by patient-reported outcomes in second-/third-line and refractory NSCLC (poster session, Abstract #702, Wednesday, July 6)

Based on results from across the PF-299 clinical trial program, Pfizer has initiated a Phase 3 trial, ARCHER 1009, evaluating PF-299 vs erlotinib for the treatment of patients with locally advanced or metastatic NSCLC following progression after, or intolerance to, at least one prior chemotherapy. ARCHER 1009 will assess the efficacy and safety of PF-299 in two co-primary populations: all enrolled patients, and enrolled patients with KRAS wild type status. The ARCHER 1009 study is open for enrollment in the US and will be enrolling soon in other countries.

PF-299 targets multiple receptors of the HER pathway. PF-299 is an irreversible inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases.

Crizotinib Data to be presented:

At the WCLC, data on the anti-tumor activity, safety, overall survival, patient-reported and quality-of-life outcomes observed in clinical trials of Pfizer's crizotinib will be presented.

• Phase 2 data for crizotinib in ALK-positive advanced NSCLC: PROFILE 1005 (oral presentation, Abstract #1618, Wednesday, July 6)
• PROFILE 1005: Preliminary patient-reported outcomes (PROs) from an ongoing Phase 2 study of crizotinib in ALK-positive advanced NSCLC (oral presentation, Abstract #1510, Wednesday, July 6)
• Crizotinib improves overall survival of ALK-positive patients with advanced NSCLC compared with historical controls (oral presentation, Abstract #1207, Wednesday, July 6)
• Efficacy of crizotinib in retrospective comparisons with standard-of-care (SOC) regimens from three Pfizer-sponsored clinical trials in patients with advanced NSCLC (poster session, Abstract #1349, Wednesday, July 6)

Crizotinib is an investigational agent that inhibits ALK, which blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells. Preliminary epidemiology suggests that approximately 3-5 percent of NSCLC tumors are ALK-positive.