Abstract 1092P
Background
Longitudinal assessment of health-related quality of life (HRQoL) is important to increase our understanding of the trajectory of patients’ self-reported health status associated with cancer treatment. In this international, single-arm, open-label, phase II trial (JAVELIN Merkel 200; NCT02155647), treatment-naïve patients with mMCC received first-line treatment with avelumab 10 mg/kg every 2 weeks. The study aimed to evaluate patients’ HRQoL over a 15-month follow-up period.
Methods
HRQoL was assessed using disease-specific (FACT-M) and generic (EQ-5D visual analogue scale [EQ VAS]) questionnaires at baseline, week 7, and every 6 weeks thereafter until progressive disease (PD) and/or treatment discontinuation. Mixed-effect models for repeated measures (MMRM) analyses were conducted using all HRQoL data provided to evaluate changes over time. The impact of PD on HRQoL was also assessed through these models by dichotomizing the sample into PD and non-PD (stable disease or partial/complete response) groups.
Results
In 116 enrolled patients, 538 HRQoL assessments were analyzed; HRQoL questionnaire compliance rate was >75% overall. HRQoL was relatively stable across all patients, with 9 of 12 FACT-M subscales and EQ-VAS showing a smaller change from baseline than the minimal important difference (MID) threshold, indicating no clinically relevant change. When comparing PD vs non-PD groups, clinically meaningful differences reaching MID threshold were observed across almost all (10/12) FACT-M subscales and EQ VAS. For example, for the FACT-M total score (MID=5), the difference was estimated at 9.52 (95% CI: 6.05, 12.98), favoring the non-PD group.
Conclusions
These findings show unique longitudinal HRQoL data for treatment-naïve patients with mMCC treated with avelumab. Despite a decreasing sample size over the 15-month study period, as expected in the context of an aggressive cancer such as mMCC, HRQoL scores were relatively stable over time. Non-PD with avelumab treatment was associated with statistically and clinically meaningful better HRQoL compared with PD.
Clinical trial identification
NCT02155647.
Editorial acknowledgement
Legal entity responsible for the study
Merck KGaA, Darmstadt, Germany.
Funding
Merck KGaA, Darmstadt, Germany, and is part of an alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, NY, USA.
Disclosure
M. Bharmal: Full/Part-time employment: EMD Serono, Inc.; a business of Merck KGaA, Darmstadt, Germany. S. Nolte: Full/Part-time employment, Clinical research consulting: ICON plc. C. Lebbé: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Roche; Officer/Board of Directors: Avantis Medical Systems; Honoraria (self): Pierre Fabre; Honoraria (self): Pfizer; Honoraria (self): Incyte; Advisory/Consultancy: EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany; Advisory/Consultancy: Sanofi. L. Mortier: Travel/Accommodation/Expenses: Bristol-Myers Squibb; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Roche/Genentech. A.S. Brohl: Advisory/Consultancy: Bayer; Advisory/Consultancy: EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany; Advisory/Consultancy: Deciphera; Advisory/Consultancy: PierianDx. N. Fazio: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Ipsen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): AAA; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Merck KGaA, Darmstadt, Germany; Honoraria (self): Sanofi-Aventis; Advisory/Consultancy: Wren Laboratories Europe; Advisory/Consultancy, Research grant/Funding (self): Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Research grant/Funding (self): Merck Sharpe & Dohme. J-J. Grob: Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Amgen; Advisory/Consultancy: Merck KGaA, Darmstadt, Germany; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi. N. Prinzi: Travel/Accommodation/Expenses: Novartis. G.J. Hanna: Honoraria (self): Bio-Rads; Advisory/Consultancy, Research grant/Funding (institution): Regeneron; Advisory/Consultancy, Research grant/Funding (institution): Sanofi Genzyme; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy: Maverick; Advisory/Consultancy: Merck KGaA, Darmstadt, Germany; Advisory/Consultancy: Kura; Advisory/Consultancy: Prelude; Advisory/Consultancy: Bicara; Research grant/Funding (self): Exicure; Research grant/Funding (institution): GlaxoSmithKline; Research grant/Funding (institution): NantKWest; Research grant/Funding (institution): Kite; Research grant/Funding (institution): Kartos; Research grant/Funding (institution): ASCO; Research grant/Funding (institution): CCF; Research grant/Funding (institution): V Foundation; Research grant/Funding (institution): Gateway for Cancer Research. J. Hassel: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self): Roche; Honoraria (self), Advisory/Consultancy: Merck Sharpe & Dohme; Honoraria (self): Novartis; Honoraria (self): Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy: Sun Pharma. F. Kiecker: Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Novartis; Honoraria (self): Pierre Fabre; Honoraria (self), Advisory/Consultancy: Roche; Advisory/Consultancy: Incyte. B. Ellers-Lenz: Full/Part-time employment: Merck KGaA, Darmstadt, Germany. M. Bajars: Full/Part-time employment: EMD Serono Research & Development Institute, Inc.; a business of Merck KGaA, Darmstadt, Germany. G. Guezel: Full/Part-time employment: Merck KGaA, Darmstadt, Germany. P. Nghiem: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Self and Immediate Family Member: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Self and Immediate Family Member: EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany; Honoraria (self), Advisory/Consultancy, Self and Immediate Family Member: UpToDate; Research grant/Funding (self), Self and Immediate Family Member: Bristol-Myers Squibb; Research grant/Funding (self), Travel/Accommodation/Expenses, Self and Immediate Family Member: Amgen; Research grant/Funding (self), Self and Immediate Family Member: Kadmon; Research grant/Funding (self), Self and Immediate Family Member: Syndax; Research grant/Funding (self), Self and Immediate Family Member: Incyte; Research grant/Funding (self), Self and Immediate Family Member: AstraZeneca; Travel/Accommodation/Expenses, Self and Immediate Family Member: Sanofi Genzyme; Travel/Accommodation/Expenses, Self and Immediate Family Member: Regeneron; Travel/Accommodation/Expenses, Self and Immediate Family Member: Merck, Sharp & Dohme. M. Hunger: Advisory/Consultancy, Research grant/Funding (self), Full/Part-time employment: ICON plc. M. Schlichting: Full/Part-time employment: Merck KGaA, Darmstadt, Germany. M. Henry-Szatkowski: Advisory/Consultancy: Merck KGaA, Darmstadt, Germany; Full/Part-time employment: ICON, plc. S. D'Angelo: Advisory/Consultancy, Research grant/Funding (self): Amgen; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: EMD Serono, Inc.; a business of Merck KGaA, Darmstadt, Germany; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Immune Design; Advisory/Consultancy, Research grant/Funding (self): Incyte; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Merck & Co; Advisory/Consultancy, Research grant/Funding (self): Nektar; Research grant/Funding (self): Bristol-Myers Squibb; Research grant/Funding (self): Deciphera; Travel/Accommodation/Expenses: Adaptimmune.