Pfizer’s Phase III study of lung cancer drug Xalkori meets primary objective

27th March 2014 (Last Updated March 27th, 2014 01:00)

US-based pharmaceutical firm Pfizer has released positive results of PROFILE 1014, a Phase III trial of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib) in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC).

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US-based pharmaceutical firm Pfizer has released positive results of PROFILE 1014, a Phase III trial of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib) in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC).

The trial of crizotinib met its primary objective of significantly prolonging progression-free survival (PFS) in NSCLC patients when compared with standard platinum-based chemotherapy regimens.

The company said that PROFILE 1014 is the second positive global Phase III trial that evaluated Xalkori against chemotherapy, a standard of care for patients with advanced NSCLC.

Pfizer Oncology senior vice-president of clinical development and medical affairs and chief medical officer Mace Rothenberg said the results of the PROFILE 1014 study are important in that they show, for the first time, that Xalkori is superior to standard chemotherapy doublet regimens in prolonging survival without progression as first-line treatment for patients with ALK-positive advanced NSCLC.

"These findings build upon the data from the PROFILE 1007 randomised Phase III study in previously treated patients and collectively establish XALKORI as a standard of care in both the first and second-line setting for patients with ALK-positive advanced NSCLC," Rothenberg said.

The company said that no unexpected safety issues were identified in the PROFILE 1014 study, while the adverse events observed were consistent with the known safety profile for Xalkori.

"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."

The Chinese University of Hong Kong professor of clinical oncology Tony Mok said the data from the PROFILE 1014 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 for each patient.

"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," Mok said.

In 2011, the US Food and Drug Administration (FDA) had approved Xalkori as part of its accelerated approval programme.

FDA granted regular approval for Xalkori in 2013, based on the results of PROFILE 1007, a Phase III trial showing that the drug significantly prolonged PFS in previously treated patients with ALK-positive advanced NSCLC when compared to single agent chemotherapy.

So far, more than 8,000 patients have been treated with Xalkori, which is now approved in 74 countries, including Australia, Canada, China, Japan, South Korea and the European Union (EU).


Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.