Pfizer Inc. (PFE) announced Tuesday that a Phase 3 study of its lung cancer compound Xalkori or crizotinib met its primary endpoint in previously treated patients with anaplastic lymphoma kinase or ALK-positive advanced non-small cell lung cancer or NSCLC. According to Pfizer, Xalkori significantly improved progression-free survival when compared with pemetrexed or docetaxel.
The study namely - Profile 1007 - is the first randomized Phase 3 study in ALK-positive advanced NSCLC patients.
Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit 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."
The company said adverse events observed on crizotinib and chemotherapy in Profile 1007 were generally consistent with their respective known adverse event profiles.
Pfizer said it continues to study the therapy in several ongoing trials including Profile 1014, a Phase 3, open-label, randomized, two-arm study to evaluate the safety and efficacy of Xalkori in comparison with pemetrexed plus cisplatin or carboplatin in patients previously untreated for ALK-positive advanced NSCLC.
In addition, Profile 1005 study is an ongoing Phase 2 open-label, single-arm study on the efficacy and safety of Xalkori in patients with ALK-positive advanced NSCLC who have failed more than one line of treatment with prior chemotherapy.
In Europe, lung cancer accounts for 20 percent of all cancer-related deaths and non-small cell lung cancer accounts for about 85 percent of lung cancer cases.
PFE is currently trading at $22.74, up 0.53 percent, on a volume of 2.96 million shares on the NYSE.
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