The Profile 1007 study demonstrated that Xalkori significantly improved progression-free survival (PFS) when compared with pemetrexed or docetaxel, which was the primary endpoint.
Pfizer Oncology Business Unit clinical development and medical affairs senior vice president Mace Rothenberg said the results 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.
"This 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 for that disease," Rothenberg added.
The adverse events observed on crizotinib and chemotherapy in randomized Phase 3 study were generally consistent with their respective known adverse event profiles.
Xalkori is FDA approved for the treatment of locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test. The compound also gained approval in countries such as Canada, Korea, Japan and Switzerland.