Pfizer reports positive data from new Xalkori study

Pfizer has announced positive data from a new phase III trial of Xalkori, its treatment for non-small cell lung cancer (NSCLC).

Results from PROFILE 1029 showed the drug met its primary objective of significantly prolonging progression-free survival in previously untreated East Asian patients with ALK-positive advanced NSCLC when compared to a standard chemotherapy doublet.

In this study, Xalkori was used as the first systemic therapy, with subjects receiving therapy and/or surgery for early-stage disease before they were diagnosed with metastatic disease.

Adverse events observed in the study were generally consistent with findings from previous trials, with no unexpected side effects observed. This was the second positive phase III study for Xalkori in the first-line setting and the third positive phase III study for the drug in ALK-positive NSCLC.

Dr Mace Rothenberg, senior vice-president of clinical development and medical affairs and chief medical officer for Pfizer Oncology, said the data is "consistent with the results of previous global randomised clinical trials that included Asian and Western patients, which also demonstrated an improvement in progression-free survival compared to standard-of-care chemotherapy".