INTRODUCTION: Nivolumab was licensed in Europe as monotherapy for second-line metastatic non-small cell lung cancer (NSCLC) in 2015. The National Institute for Health and Care Excellence (NICE) recommended reimbursement via the Cancer Drugs Fund (CDF) for all patients of squamous histology and non-squamous histology patients with PD-L1 expression ≥1%. During this period, real-world evidence on patient characteristics and outcomes was collected by Public Health England using the Systemic Anti-Cancer Therapy (SACT) dataset. We reviewed SACT data with the registrational CM017 and 057 trials, to assess the generalisability of these trial data to the real-world setting.
METHODS: Data included all patients with a CDF application from September 2017 to December 2018 with follow-up until 31 January 2019. Baseline characteristics included sex, age, performance status and PD-L1 distribution. Endpoints included overall survival (OS) and treatment duration(DOT).
RESULTS: In total, 448 new CDF applications were received; after appropriate exclusions there were 391 patients (348 squamous / 43 non-squamous) included in the SACT analysis. This compares to 135 patients from CM017 and 292 from CM057. For squamous-NSCLC, median age was 70 years; 66% were male. 17% had an ECOG performance score(PS) of 0 and 71% of 1. Median OS was 8.4 months (95% CI, 7.2‑9.7 months) compared with a median OS of 9.2 months (95% CI: 7.3-12.6 months) in CM017. The median DOT in SACT was 3.5 months. For non-squamous, the median age was 65 years; 67% were male.21% had a PS of 0 and 67% of 1. Median OS was 9.2 months (CIs not available) compared with 12.21 months (95% CI: 9.7-15.1 months) in CM057 (Figure 2). Median DOT was 4.1 months.
CONCLUSION: Median OS in SACT are similar to those in CM017 and CM057 suggesting the trial data are generalisable to the real-world setting.
