Phase III NSCLC data for Xalkori published

Pfizer Inc. (NYSE:PFE) said twice-daily oral Xalkori crizotinib led to a median progression-free survival (PFS) of 7.7 months, the primary endpoint, vs. 3 months for investigator's choice of Alimta pemetrexed from Eli Lilly and Co. (NYSE:LLY) or docetaxel (p<0.001) in the Phase III PROFILE 1007 trial to treat advanced non-small cell lung cancer (NSCLC).

Pfizer said Xalkori also met the secondary endpoint of improving objective response rate (ORR) vs. investigator's choice of chemotherapy (65% vs. 20%, p<0.001). However, an interim analysis of the secondary overall survival (OS) endpoint showed no significant improvement with Xalkori compared to chemotherapy. Specifically, Xalkori led to a median OS of 20.3 months vs. 22.8 months for chemotherapy after 40% of the total number of events required for the final OS analysis occurred (p=0.54). The trial enrolled 347 patients with previously treated ALK-positive advanced NSCLC. Data were published in the New England Journal of Medicine. ...