Pfizer has 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 the 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.
Xalkori was the first ALK inhibitor approved by regulatory authorities in the U.S., European Union, China and Japan, and it now is approved in more than 85 countries. Xalkori is widely recognized as a standard-of-care for patients with ALK-positive advanced NSCLC. To date, more than 20,000 patients have been treated with Xalkori worldwide.