Pfizer’s Xalkori meets PFS endpoints in untreated NSCLC patients

US pharma behemoth Pfizer (NYSE: PFE) says that PROFILE 1014, a Phase III study of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) when compared to standard platinum-based chemotherapy regimens.

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

“The results of the PROFILE 1014 study 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 for patients with ALK-positive advanced NSCLC,” said Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer Oncology.