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Pfizer Says Phase 3 Study PROFILE 1007 Evaluating XALKORI Met Primary Goal

Pfizer Inc. (PFE) said that the PROFILE 1007 study achieved its primary endpoint, showing that XALKORI (crizotinib) significantly improved progression-free survival when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase, or ALK-positive advanced non-small cell lung cancer, or NSCLC.

According to the company, PROFILE 1007 is the first randomized Phase 3 study in ALK-positive advanced NSCLC patients.

"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," said Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit. "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."

Pfizer noted that the adverse events observed on crizotinib and chemotherapy in PROFILE 1007 were generally consistent with their respective known adverse event profiles. Full efficacy and safety data from the study would be presented at an upcoming medical congress.

by RTT Staff Writer

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