Pfizer has reported positive late-stage data on a trial of Xalkori compared to chemotherapy in previously-untreated lung cancer patients with a specific gene mutation.

The Phase III study of Xalkori (crizotinib) met its primary objective of significantly prolonging progression-free survival in previously-untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-squamous non-small cell lung cancer (NSCLC) when compared to standard platinum-based chemotherapy regimens. The trial is the second late-stage study that evaluated Xalkori against chemo.

The treatment is widely approved as second-line therapy for PFS in previously-treated patients with ALK-positive advanced NSCLC when compared to single-agent chemotherapy. Getting approval as a first-line treatment would already boost Xalkori's already-substantial sales; fourth-quarter revenues reached $89 million, up 98%.

Mace Rothenberg, chief medical officer for Pfizer Oncology, says that the latest results are important "in that they demonstrate, for the first time, that Xalkori is superior to standard chemotherapy doublet regimens in prolonging survival without progression as first-line treatment". The two trials "collectively establish Xalkori as a standard of care in both the first and second-line setting for patients with ALK-positive advanced NSCLC".

Tony Mok at the Chinese University of Hong Kong added that the data from the new study "highlight the importance of not only testing a tissue specimen for the presence of biomarkers at the time of diagnosis in all patients with advanced stage NSCLC, but actually having those results in hand before determining the most appropriate treatment option". He added that “it is clear that a multidisciplinary collaborative approach to molecular testing is required in order to deliver those results on time, which in fact is the foundation of personalised medicine in lung cancer".