Phase III Study: Crizotinib Prolongs Progression-Free Survival in Previously Untreated ALK-Positive Advanced NSCLC
In the phase III PROFILE 1014 study, the anaplastic lymphoma kinase (ALK) inhibitor crizotinib (Xalkori) was found to significantly prolong progression-free survival in previously untreated patients with ALK-positive advanced nonsquamous non–small cell lung cancer (NSCLC) compared with standard platinum-based chemotherapy.
No unexpected safety issues were identified in the current study, and adverse events were consistent with the known safety profile for crizotinib. Efficacy and safety data from this study will be submitted for presentation at a future medical meeting.
Effective in First- and Second-Line Settings
“The results of the PROFILE 1014 study are important in that they demonstrate, for the first time, that [crizotinib] is superior to standard chemotherapy doublet regimens in prolonging survival without progression as first-line treatment for patients with ALK-positive advanced NSCLC,” said Mace Rothenberg, MD, 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 III study in previously treated patients and … establish [crizotinib] as a standard of care in both the first- and second-line setting for patients with ALK-positive advanced NSCLC.”
“These data … 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 Tony Mok, MD, of 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.”
Crizotinib was first approved in 2011 through the accelerated approval program of the U.S. Food and Drug Administration. It was granted regular approval in 2013 based on the results of PROFILE 1007, a phase III study demonstrating that crizotinib significantly prolonged progression-free survival in previously treated patients with ALK-positive NSCLC compared with single-agent chemotherapy.
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