Phase III ALUR study supports the use of Alecensa for advanced ALK-positive lung cancer

The Phase III ALUR study met its primary endpoint, demonstrating that Alecensa (alectinib) significantly improved progression-free survival (PFS) in people with anaplastic lymphoma kinase (ALK)-positive advanced (metastatic) non-small cell lung cancer (NSCLC) who had progressed following treatment with one prior line of both platinum-based chemotherapy and crizotinib, Pfizer's Xalkori, compared with chemotherapy.

In February this year, Swiss pharmaceutical giant Roche was granted conditional approval from the European Medicines Agency for Alecensa, which gained Canadian approval in October 2016. Alecensa, developed by Roche’s Genentech subsidiary, has been available in the USA since December 2015 and Israel to ALK-positive metastatic NSCLC patients who have progressed on or are intolerant to crizotinib, and in Japan to ALK-positive unresectable, recurrent or advanced NSCLC patients. The peer-reviewed data will be published later this year .The drug posted revenues of 182 million francs ($181.8 million) in 2016.

“We are pleased to announce that the results of the Phase III ALUR trial further support the use of Alecensa as a treatment for people with ALK-positive lung cancer who, after having progressed on both chemotherapy and crizotinib, are in need of new treatment options,” said Sandra Horning, chief medical officer and head of global product development. “The results of this trial will support our access discussions with global health authorities as we seek to bring Alecensa to patients faster,” Dr Horning noted.

Alecensa is also being explored as a first-line treatment option with the Phase III ALEX study comparing Alecensa to crizotinib in ALK-positive NSCLC. The ALEX study is expected to report data in the first half of 2017.