July 2018
By Tom Newsom-Davis, Consultant Oncologist
NICE has just approved Alectinib as first line treatment for ALK-translocated NSCLC.
https://www.nice.org.uk/guidance/gid-ta10206/documents/final-appraisal-determination-document
This is exciting news for patients with this comparatively rare type of lung cancer.
Currently the standard of care in the NHS for patients with advanced stage disease is the ALK inhibitor, Criztoinib. Recently however the ALEX study showed that Alectinib has greater clinical benefit compared to Crizotinib extending progression free survival by an unprecedented 15 months (10.4 vs. 25.7 months) and reducing the incidence of brain metastases whilst on treatment (9.4% vs. 41.4%). Alectinib was associated with a favourable side effect profile, having fewer grade 3-4 adverse reactions compared to Criztoinib (50% vs. 41%).
The BO28984 (ALEX) trial was an international, randomized, open-label, phase 3 trial comparing alectinib (600 mg twice daily) with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. At the link below is the report of data from the primary analysis, including the primary end point (investigator-assessed progression-free survival) and secondary end points.
https://www.nejm.org/doi/full/10.1056/NEJMoa1704795