Patient Experiences with Avelumab in Treatment-Naïve Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial

Abstract

Background and objective: Avelumab is approved for the treatment of metastatic Merkel cell carcinoma, a rare aggressive skin cancer with a poor prognosis. The aim of this qualitative study embedded in a clinical trial was to explore patient experiences while receiving avelumab.

Methods: All treatment-naïve patients with metastatic Merkel cell carcinoma entering part B of the phase II, open-label, international, JAVELIN Merkel 200 trial (NCT02155647) were invited to participate in optional semi-structured phone interviews before avelumab administration (baseline) and at weeks 13 and 25. Interviews were conducted by trained professionals, audio-recorded, transcribed and analysed. Key concepts identified at baseline were assessed during follow-up interviews.

Results: Twenty-nine patients completed the baseline interview; 19 had at least one follow-up interview. Baseline interviews described the patients' challenging journeys before being correctly diagnosed with Merkel cell carcinoma, the negative psychological burden of living with a symptomless disease and the hope for avelumab to be a successful therapy. During the trial, most patients reported an increased or continued sense of hope and willingness to fight metastatic Merkel cell carcinoma. Patients who self-reported disease improvement (n = 12) also reported stability or improvement in physical well-being and ability to do daily activities, having more energy, worrying less and being optimistic. Six patients who reported their condition as stable (n = 4) or worsened (n = 3) reported a worsening of physical well-being. Nine patients reported fatigue/tiredness on the day of and after receiving avelumab. Baseline and longitudinal experiences were similar across countries.

Conclusions: This study suggests that patients experience perceptible benefits in physical and psychological well-being following treatment success with first-line avelumab in metastatic Merkel cell carcinoma.

Conflict of interest statement

Jérémy Lambert and Alexia Marrel are employees of ICON, and were paid consultancy fees by Merck KGaA. Murtuza Bharmal is an employee of EMD Serono, a business of Merck KGaA, Darmstadt, Germany. Melissa A. Burgess reports serving as a consultant or advisor for EMD Serono and Immune Design. Nicola Fazio provided speaker and advisory board services for AAA Pharma, Ipsen, Merck KGaA, Merck Sharp & Dohme, Novartis and Pfizer. Thilo Gambichler received speakers and/or advisory board honoraria from Abbvie, Almirall, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Roche, Pfizer, Pierre Fabre and Sanofi-Genzyme. Jean-Jacques Grob has received honoraria from Amgen, Bristol-Myers Squibb, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre, Roche and Sanofi; reports serving as a consultant or advisor for Amgen, Brystol-Myers Squibb, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre, Roche and Sanofi; is a member of a speakers’ bureau for Novartis; and has received reimbursement for travel and accommodations expenses from Brystol-Myers Squibb, Merck Sharp & Dohme, Novartis and Pierre Fabre. Céleste Lebbé has received honoraria from Amgen, Bristol-Myers Squibb, Incyte, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre and Roche; reports serving as a consultant or advisor for Amgen, Bristol-Myers Squibb, Merck Sharpe & Dohme, Novartis and Roche; is a member of a speakers’ bureau for Amgen, Bristol-Myers Squibb, Novartis and Roche; has received research funding from Bristol-Myers Squibb and Roche; has received reimbursement for travel and accommodation expenses from Bristol-Myers Squibb; and has other relationships with Avantis Medical Systems. Jeffrey Russell is an employee of Immunocore. Gülseren Güzel is an employee of Merck KGaA. Sandra P. D’Angelo reports serving as a consultant or advisor for Amgen, EMD Serono, GlaxoSmithKline, Immune Design, Incyte, Merck & Co. and Nektar; received research grants from Amgen, Bristol-Myers Squibb, Deciphera, EMD Serono, Incyte, Merck & Co. and Nektar; and received reimbursement for travel and accommodation expenses from Adaptimmune, EMD Serono and Nektar. Caroline Robert reports advisory roles for BMS, Piere Fabre, Novartis and Amgen and reports ownership of equity from Merck KGaA, Roche, MSD, Sanofi, Biotherma and Ultimovacs. Bartosz Chmielowski has no conflict of interest to declare.

Figures

Fig. 1

Conceptual model of the journey of patients with Merkel cell carcinoma (MCC) and its management before diagnosis to study entry. Red: concepts related to an impact; yellow: concepts related to symptoms/side effects; purple: concepts related to perceived treatment efficacy and pectations; light green: concepts related to descriptive facts; light blue: concepts related to diagnostic issues

Fig. 2

Changes in various dimensions of health-related quality of life at last available time point in patients with disease that had improved (n = 12), were stable (n = 4) or had worsened (n = 3) per patient self-report. Green, grey and orange arrows represent patient-reported improvement, stability and worsening in each health-related quality-of-life domain, respectively. Arrow size is proportional to the number of subjects experiencing improvement, no change and worsening in each health-related quality-of-life domain