Phase III ALUR study of Alecensa (alectinib) significantly improved progression-free survival in people with ALK-positive advanced (metastatic) non-small cell lung cancer.- Roche

Roche has announced that 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, compared with chemotherapy. The peer-reviewed data will be published later this year. Alecensa received conditional marketing authorisation from the European Commission in people with ALK-positive NSCLC previously treated with crizotinib on 16 February 2017 based on the results of the phase I/II NP286733 and NP287614 studies. Alecensa is also approved as a monotherapy (alone) for people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in the US and nine other countries globally. In addition, Alecensa is approved in Japan for people whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable).

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.

ALUR (NCT02604342) is a randomised, multi-centre, open-label phase III study evaluating the efficacy and safety of Alecensa versus chemotherapy (pemetrexed or docetaxel) in people with ALK-positive NSCLC previously treated with one prior line of both platinum-based chemotherapy and crizotinib. People were randomised (2:1) to receive either Alecensa or chemotherapy. The primary endpoint of the ALUR study is PFS and secondary endpoints include: overall survival (OS), central nervous system (CNS) objective response rate (ORR) in people with measurable brain metastases at baseline and median time to CNS progression. The multicentre study was conducted in 119 people across 15 countries.