The ALK project: a real-world national network and database

Abstract

Introduction: NSCLC patients with ALK translocation are rare, accounting for 1600 cases/year in England. Our group established an ALK network across the UK with the aim to analyse treatment patterns/outcomes, promote research and establish a collaborative network. Methods: As part of this active project and expanding network, we conducted a multicentre retrospective analysis across 23 NHS England trusts on ALK+ patients who were offered treatment until Sept-2018 with any of the newer generation ALK inhibitors (ceritinib, alectinib, brigatinib and lorlatinib). The primary aim of this study was overall survival (OS). The secondary aims were analysing treatment patterns, treatment exposure times (surrogate of clinical benefit) and objective response rates (ORR). Results: A total of 181 patient files were included in the ALK Project database by Sept-2018, of which 132 received a newer generation ALK inhibitor. 87% had advanced/metastatic disease at diagnosis with a median age of 53 years, being 54% females and 69% never smokers. The median OS was 6.2 years (95% CI, 4.9-7.4). Median OS was not reached for the 48% of patients with no known brain metastasis. 45% of patients received chemotherapy prior to an ALK inhibitor, 12% of which after the approval of 1st line ALK inhibitors. 6% of patients received immunotherapy, of which only 1 patient achieved disease control. On average patients received 3 lines of treatment, having received ceritinib (63%), brigatinib (37%), alectinib (21%) and/or lorlatinib (14%). The exposure times and ORRs per drug are available in Table 1. Reassessment of genomic profile during therapy with ALK inhibitors was performed in 10% of cases. Conclusion: Big real-world data is vital for rare diseases subtypes. A nationwide collaboration is possible and should be promoted. The remarkable survival of these patients mirrors the revolution in their treatment landscape. All efforts should be done to exclude ALK rearrangement, particular in never smokers.