Phase III results for Xalkori in NSCLC published in NEJM-Pfizer

Pfizer announced the publication of results from the PROFILE 1014 study in the December 4 issue of The New England Journal of Medicine. PROFILE 1014 is a Phase III study of Xalkori (crizotinib) in previously untreated patients with ALK-positive advanced Non-Small Cell Lung Cancer (NSCLC). These results demonstrated that Xalkori 250 mg twice daily significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced NSCLC when compared to standard platinum-based chemotherapy regimens. The adverse events were consistent with the known safety profile for Xalkori.

The PROFILE 1014 study met its primary objective, with Xalkori significantly prolonging PFS in previously untreated patients with ALK-positive advanced NSCLC when compared to standard platinum-based chemotherapy regimens (median PFS 10.9 vs. 7.0 months). Xalkori also demonstrated significantly higher objective response rate (ORR) when compared to standard platinum-based chemotherapy regimens (74% vs. 45%). With the majority of patients still in follow-up for survival at the time of the final PFS analysis and over two-thirds of the patients randomized to the chemotherapy arm of the study subsequently receiving Xalkori, median overall survival was not reached in either treatment arm.