PROFILE 1029 trial for Xalkori (crizotinib)success in prolonging PFS for ALK + NSCLC.- Pfizer

Pfizer Inc. announced that PROFILE 1029, a Phase III study of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) when compared to a standard chemotherapy doublet.

In this study, Xalkori was used as the first systemic therapy for patients with advanced ALK-positive NSCLC, and patients could have received therapy and/or surgery for early stage disease before they were diagnosed with metastatic disease. The adverse events observed with Xalkori in the study were generally consistent with findings from previous trials. No unexpected adverse events were observed. Efficacy and safety data from PROFILE 1029 will be submitted for presentation at a future medical meeting. PROFILE 1029 is the second positive Phase III study for Xalkori in the first-line setting and the third positive Phase III study for Xalkori in ALK-positive NSCLC. The PROFILE 1014 and PROFILE 1007 trials demonstrated that Xalkori was superior to chemotherapy in the first-line and the second-line settings, respectively.

Comment: Xalkori was FDA approved for ALK + NSCLC in June 2011. The drug was approved in the EU in October 2012.