Pfizer Reveals Xalkori (Crizotinib) Prolongs Survival In ALK Positive NSCLC Patients in its Phase 3 PROFILE 1007 Study
Pfizer has revealed data of the PROFILE 1007 study showing that Xalkori (Crizotinib) improved progression free survival (PFS) in previously treated ALK positive advanced NSCLC patients, when compared to docetaxel or pemetrexed. Incidentally, PROFILE 1007 is the first randomized Phase 3 study in ALK positive advanced NSCLC patients.
The study shows that crizotinib is superior to standard chemotherapy in prolonging survival among ALK positive NSCLC patients. The data also proves that genetic abnormalities in a cancer may be targeted to improve treatment and care for disease.
Changes in the ALK gene (anaplastic lymphoma kinase) are believed to be the prime initiator of cancer progression in NSCLC. Xalkori blocks cellular signal pathways to arrest development of tumor. It has become the standard care of ALK positive advanced NSCLC post accelerated approval by the FDA in August 2011.
What is Xalkori (Crizotinib)?
Crizotinib is an ALK and ROS1 (c-ros oncogene 1, receptor tyrosine kinase) inhibitor. It is currently undergoing clinical trials for safety and efficacy. Crizotinib has an amino-pyridine structure. Patients who are ALK positive have a gene fusion contributing to their condition – EML4 (echinoderm microtubule associated protein-like 4) and ALK create a fusion gene leading to changes in kinase activity and thereby initiates carcinogenesis. This kinase activity of the fusion gene is inhibited by crizotinib. Young nonsmokers without EGFR mutations of the K-ras gene have been found to be positive for this gene fusion.
Xalkori is a prescription medicine used to treat non-small cell lung cancer that is advanced or has spread to the other parts of the body and is caused by a defect in a gene called ALK. Xalkori approval is based on the percentage of patients whose tumors responded to treatment. For more information on Xalkori click here.
Given below are the list of clinical trials for NSCLC.