81P - Health-Related Quality of Life (HRQoL) in Patients (Pts) With Merkel Cell Carcinoma (MCC) Receiving Avelumab (81P)

Date 08 December 2017
Event ESMO Immuno-Oncology Congress 2017
Session Lunch & Poster Display session
Topics Cancer and pregnancy
Breast Cancer
Cancer in Special Situations
Presenter Murtuza Bharmal
Citation Annals of Oncology (2017) 28 (suppl_11): xi6-xi29. 10.1093/annonc/mdx711
Authors M. Bharmal1, P. Williams2, M. Hennessy3, M. Schlichting4, M. Hunger5, A. Marrel2, H. Kaufman6
  • 1Medical Oncology, Merck KGaA, 64293 - Darmstadt/DE
  • 2Patient-centered Outcomes, Mapi, Lyon/FR
  • 3Stats, Merck KGaA, Darmstadt/DE
  • 4Stats, Merck KGaA, 64293 - Darmstadt/DE
  • 5Real-world Strategy & Analytics, Mapi, Munich/DE
  • 6Oncology, Rutgers Cancer Institute of Mew jersey, 08901 - New Brunswick/US

Abstract

Background

In a single-arm, open-label phase 2 trial (NCT02155647 Part A) of avelumab 10 mg/kg q2w, pts with stage IV MCC pretreated with chemotherapy were followed for HRQoL and clinical outcomes. The primary analysis (6 months after enrolment of the last pt) showed nonprogression during avelumab treatment was associated with clinically meaningful improvements in HRQoL. Here we report interim results 12 months after enrollment of the last pt.

Methods

HRQoL was assessed using FACT-Melanoma (FACT-M) and EQ-5D questionnaires at baseline (BL), week 7, every 6 weeks thereafter until disease progression (PD), and at end of treatment (EOT). Linear mixed models (LMM) assessed change from BL until week 49 for FACT-M scales, including covariates of time and PD vs. non-PD. Minimally important differences (MIDs) derived from MCC populations were used to interpret the meaningfulness of changes. Sensitivity analyses (pattern-mixture models) provided estimates assuming missing values were nonrandom. Health utility was assessed by EQ-5D using similar methods.

Results

Overall, no meaningful changes from BL were seen for FACT-M scales during treatment visits up to week 49 in 70 analyzed pts. However, at the final HRQoL assessment before EOT and at EOT, meaningful worsening in HRQoL was observed for all scales, primarily associated with PD at EOT (63.6%). LMM showed significant differences between PD vs non-PD pts in the expected directions in the range of MIDs for (mean change) physical well-being (1.40), emotional well-being (1.52), melanoma (3.07), TOI (5.68), FACT-G total (4.37) and FACT-M total (7.03). The models showed improvement in emotional well-being (1.70) for non-PD pts and worsening in physical well-being (-1.68), TOI (-4.01), FACT-G total (-4.44) and FACT-M total (-5.64) for PD pts. Sensitivity analyses showed outcomes did not differ by timing of dropout. Mean health utility EQ-5D scores based on the US (UK) value set was 0.8024 (0.8269) for non-PD pts and 0.7352 (0.7415) for PD pts.

Conclusions

Consistent with previous findings, nonprogression during avelumab treatment contributed to statistically and clinically meaningful improvements in HRQoL in this longer-term 12-month follow-up analysis.

Clinical trial identification

NCT02155647 Part A

Legal entity responsible for the study

N/A

Funding

This study was funded by and is part of an alliance between Merck KGaA and Pfizer, Inc, NY, USA.

Disclosure

M. Bharmal, M. Schlichting: employee of Merck KGaA, Darmstadt, Germany, P. Williams, M. Hunger, A. Marrel: Mapi employees, consultant for Merck KgaA, M. Hennessy: employee of EMD Serono, H. Kaufman: received research grants from Amgen, Merck. Merck, provided consulting for Amgen, Celldex, EMD Serono, Merck, Prometheus, Sanofi, Turnstone Biologics participated in Speaker’s buereau’s for Merck. Merck, has received honoraria from Amgen, Celldex, EMD Serono, Merck, Prometheus, Sanofi, Turnstone Biologics