Pfizer has unveiled data which shows that Xalkori significantly improved progression-free survival in previously-treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.
Xalkori (crizotinib) was approved by the US Food and Drug Administration last August for ALK-positive advanced NSCLC but Pfizer notes that this latest trial, Profile 1007, is the first randomised Phase III study in these patients and compares the oral drug with the established intravenous chemotherapies pemetrexed and docetaxel.
Pfizer's head of oncology, Mace Rothenberg, said that "these results are important because they demonstrate, for the first time, that Xalkori is superior to standard chemotherapy in prolonging survival without progression in patients with previously-treated ALK-positive advanced NSCLC". He added that the study "provides further support for the precision medicine approach to drug development being taken at Pfizer by demonstrating how knowledge about the underlying genetic abnormalities within a cancer can be used to improve the standard of care".
The adverse events observed on crizotinib and chemotherapy in Profile 1007 "were generally consistent with their respective known adverse event profiles", the company adds. Full efficacy and safety data from the study will be presented at an upcoming medical congress.