Roche’s Alecensa approved in China

The approval follows European Medicines Agency (EMA) and US Food and Drug Administration (FDA) approvals. It is based on primary analyses from the pivotal global phase III ALEX study, a head to head study comparing progression free survival under alectinib therapy versus the standard of care crizotinib in incurable patients with ALK-positive metastatic/advanced NSCLC. Further data stem from the Phase III ALESIA study, also investigating alectinib vs crizotinib in the first-line setting, and two Phase II studies in patients who were crizotinib-refractory.

Data from the ALEX study presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, suggest that progression-free survival (PFS) was more than tripled in people who received alectinib vs crizotinib (34.8 months vs 10.9 months) as assessed by the investigator. Overall response to Roche’s tyrosine kinase blocker was 82.9% compared to 75.5% with crizotinib. Furthermore, investigator-assessed median PFS for people without CNS metastases at baseline was 34.8 months with Alecensa versus 14.7 months with crizotinib. There is no indication that Roche can provide overall survival data soon. The company stated that overall survival data were immature with only about a third of events being reported – in June 2017, Roche reported that only about a quarter of events have being reported.

In China, around 75,000 people diagnosed with ALK-positive NSCLC every year, and the number is still rising.