Pfizer announced results from PROFILE 1014, a Phase 3 study of Xalkori (crizotinib) in previously untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-squamous non-small cell lung cancer (NSCLC). Xalkori is an ALK inhibitor.
The primary objective of PROFILE 1014 was met with Xalkori significantly prolonging progression-free survival (PFS) in these patients compared to standard platinum-based chemotherapy regimens. PROFILE 1014 is the second positive global Phase 3 study that evaluated Xalkori against chemotherapy, a standard of care for patients with advanced NSCLC.
Xalkori is already approved for the treatment of patients with metastatic non-small cell lung cancer whose tumors are ALK-positive as detected by an FDA-approved test. This approval was based on results from PROFILE 1007, a Phase 3 study demonstrating that Xalkori significantly prolonged PFS in previously treated patients with ALK-positive advanced NSCLC when compared to single agent chemotherapy.
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