MINIMAL IMPACT ON PATIENTS’ HEALTH UTILITIES ASSOCIATED WITH ADVERSE EVENTS IN METASTATIC MERKEL CELL CARCINOMA PATIENTS ON TREATMENT WITH AVELUMAB
Author(s)
Kaufman H1, Hunger M2, Hennessy M3, Schlichting M4, Bharmal M4
1Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA, 2Mapi (an ICON plc company), Munich, Germany, 3EMD Serono, Billerica, MA, USA, 4Merck KGaA, Darmstadt, Germany
OBJECTIVES: The anti-PD-L1 avelumab is the first FDA-approved treatment for metastatic Merkel cell carcinoma (mMCC), a rare, aggressive skin cancer. Avelumab has a safety profile that includes infusion reactions and a low incidence of immune-related adverse events (AEs). This research aims to explore the association between different types of AEs and EQ-5D utility in avelumab-treated patients. METHODS: EQ-5D data from a phase 2 single-arm trial (NCT02155647) of 88 patients with mMCC after failing first-line chemotherapy were analyzed. Date of data cutoff was 12 months after enrolment of the last subject. EQ-5D was assessed at baseline, week 7, every 6 weeks thereafter, and at the end-of-treatment visit. For each assessment, presence of ongoing AEs was based on start and end dates of all AEs reported in the trial. Linear mixed models were fitted to estimate reductions in utility for various AE types, adjusted for disease progression (using RECIST 1.1; determined by an IERC). RESULTS: Among 70 evaluable patients, 322 observations were analyzed. Mean utility at baseline was 0.799 (SD: 0.155) for the US, and 0.823 (SD: 0.196) for the UK tariff, respectively. In 37 of 322 observations, patients completed the EQ-5D while experiencing a treatment-emergent grade 3/4 AE. Mean reduction in utility for treatment-emergent grade 3/4 AEs was -0.024 (95% CI: -0.066; 0.018) and -0.017 (95% CI: -0.065; 0.031) based on US and UK value sets, respectively. These utility reductions and those for treatment-related or treatment-emergent AEs of any grade, and immune-related AEs, were not clinically relevant based on published estimates of minimally important differences (US, 0.06; UK, 0.07-0.09). Only serious AEs (13 observations) were associated with clinically meaningful reduction in utility (-0.061 for US; -0.098 for UK). CONCLUSIONS: The impact on health utility from patients' perspective during avelumab treatment was minimal for all AEs evaluated and marginal for serious AEs.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN198
Topic
Patient-Centered Research
Topic Subcategory
Health State Utilities
Disease
Oncology