Pfizer: Phase-3 study of Xalkori met primary endpoint

NEW YORK — Pfizer announced the results of its late-stage clinical trial of Xalkori (crizotinib).

The drug maker confirmed that its Profile 1007 study met its primary endpoint, demonstrating that the drug significantly improved progression-free survival in previously treated patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, compared with those treated with pemetrexed or docetaxel. The study also marked the first randomized phase-3 study in ALK-positive advanced NSCLC patients, Pfizer said.

"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, SVP 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."

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