Pfizer Inc. announced that PROFILE 1014, a Phase 3 study of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) when compared to standard platinum-based chemotherapy regimens. PROFILE 1014 is the second positive global Phase 3 study that evaluated Xalkori against chemotherapy, a standard of care for patients with advanced NSCLC.
“The results of the PROFILE 1014 study are important in that they demonstrate, for the first time, that Xalkori is superior to standard chemotherapy doublet regimens in prolonging survival without progression as first-line treatment for patients with ALK-positive advanced NSCLC,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “These findings build upon the data from the PROFILE 1007 randomized Phase 3 study in previously treated patients and collectively establish Xalkori as a standard of care in both the first and second-line setting for patients with ALK-positive advanced NSCLC.”
No unexpected safety issues were identified in the PROFILE 1014 study. The adverse events were consistent with the known safety profile for Xalkori. Efficacy and safety data from this study will be submitted for presentation at a future medical meeting.
“These data from the PROFILE 1014 study highlight the importance of not only testing a tissue specimen for the presence of biomarkers at the time of diagnosis in all patients with advanced stage NSCLC, but actually having those results in hand before determining the most appropriate treatment option for each patient,” said Professor Tony Mok, Li Shu Fan Medical Foundation Professor of Clinical Oncology at the Chinese University of Hong Kong. “It is clear that a multidisciplinary collaborative approach to molecular testing is required in order to deliver those results on time, which in fact is the foundation of personalized medicine in lung cancer.”
Xalkori was first approved in 2011 through the accelerated approval program of the U.S. Food and Drug Administration (FDA). It was granted regular approval in 2013 in the U.S. based on the results of PROFILE 1007, a Phase 3 study demonstrating that Xalkori significantly prolonged PFS in previously treated patients with ALK-positive advanced NSCLC when compared to single agent chemotherapy. To date, more than 8,000 patients have been treated with Xalkori1, now approved in 74 countries2, including Australia, Canada, China, Japan, South Korea and the European Union.
Date: March 25, 2014