Pfizer Announces Positive Phase 3 Results For XALKORI
Pfizer Inc. reported positive outcomes for the Phase III study of XALKORI (crizotinib) versus chemotherapy in treatment-naïve patients with ALK-positive advanced non-small cell lung cancer (NSCLC). Crizotinib is currently the only agent that has shown progression-free survival (PFS) compared to chemotherapy in two global randomized studies in first- and second-line ALK-positive NSCLC.
The Phase III PROFILE 1014 study of anaplastic lymphoma kinase (ALK) inhibitor crizotinib met its primary endpoints over standard platinum based chemotherapy regimens. “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. 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,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology.
Xalkori received approval through the accelerated approval program of the U.S. Food and Drug Administration (FDA) in 2011. Supported by the results of PROFILE 1007, a Phase 3 study demonstrating that XALKORI significantly extended PFS in previously treated patients with ALK-positive advanced NSCLC compared to single agent chemotherapy, the drug received regular approval in the U.S. in 2013. PROFILE 1014 is the second positive global Phase III study that compared Xalkori to chemotherapy in patients with advanced NSCLC.
Professor Tony Mok of Li Shu Fan Medical Foundation at the Chinese University of Hong Kong said, “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. 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.”
The drug is approved in 74 countries including the European Union, China, Canada, Japan, and South Korea.