Roche's Alecensa tops Xalkori in confirmatory NSCLC trial

Roche (SIX:ROG; OTCQX:RHHBY) said Alecensa alectinib significantly improved progression-free survival (PFS) vs. Xalkori crizotinib, meeting the primary endpoint in the Phase III ALEX trial as a first-line treatment for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.

The ALK inhibitor has accelerated approval in the U.S. and conditional approval in the EU for the indication in patients following treatment with Xalkori. Roche plans to submit ALEX's data to regulators and seek the drug's full approval in the same indication in the EU, and as a first-line treatment in the U.S. Roche plans to present full data from the 303-patient study at an upcoming medical meeting...