Abstract 4553
Background
To better understand the impact of the anti–PD-L1 antibody avelumab, clinical outcomes and PROs in chemotherapy-refractory pts with mMCC enrolled in a single-arm, international phase 2 trial (NCT02155647) were analysed. Here we explore the proportion of pts categorised as responders based on these outcome measures.
Methods
PROs were assessed at baseline (BL), at week 7, thereafter Q6W until disease progression, and at end of treatment using EQ-5D, a generic health-related quality of life (HRQoL) tool, and FACT-M, a cancer-specific HRQoL tool. Pts were categorised as meaningfully improved/stable or as meaningfully worsened. HRQoL deterioration-free survival (QFS) was defined as the time from BL to either a meaningful worsening from BL with no further improvement in HRQoL or death. QFS rates of PRO endpoints were computed at specific time points. Responders based on PRO meaningfully improved/stable and QFS analyses were described along with the best overall response (BOR) and progression-free survival (PFS) analyses assessed by IERC per RECIST v1.1.
Results
As of Sept 26, 2017, 88 pts had been followed for a minimum of 24 months (mo; median, 29.2 [range, 24.8-38.1]). The table presents responders based on PROs and CEPs at 6, 12, 18, and 24 mo. In addition, PRO-based, 2-year rates of improved/stable endpoints tended to be higher than the BOR rate of 33%, ranging from 41% for FACT-M physical well-being to 58% for FACT-M melanoma surgery scale.Table: 1282P
| 6 mo | 12 mo | 18 mo | 24 mo | ||
|---|---|---|---|---|---|
| CEPs | |||||
| PFS rate, % | 40 | 29 | 29 | 26 | |
| PRO endpoints | |||||
| QFS rate, % | EQ-5D VAS | 52 | 52 | 49 | 38 |
| FACT-M total | 45 | 40 | 36 | 32 | |
| FACT-M physical well-being | 44 | 37 | 33 | 33 | |
| FACT-M social/family well-being | 40 | 40 | 31 | 26 | |
| FACT-M emotional well-being | 45 | 40 | 33 | 33 | |
| FACT-M functional well-being | 41 | 34 | 31 | 27 | |
| FACT-M melanoma subscale | 53 | 42 | 39 | 39 | |
| FACT-M melanoma surgery scale | 46 | 43 | 38 | 38 | |
| FACT-G total | 41 | 39 | 35 | 31 |
Conclusions
The findings show similarity in the proportion of responders based on clinical and PRO endpoints, reiterating the potential association of both outcome measures in this mMCC population. This confirms the interest in using PROs in trials to contribute to the interpretation of objective CEPs.
Clinical trial identification
NCT02155647.
Legal entity responsible for the study
Merck KGaA, Darmstadt, Germany.
Funding
This trial was sponsored by Merck KGaA, Darmstadt, Germany and is part of an alliance between Pfizer and Merck KGaA, Darmstadt, Germany.
Editorial Acknowledgement
Medical writing support was provided by ClinicalThinking Inc., Hamilton, NJ, USA.
Disclosure
S.P. D'Angelo: Financial interest from EMD Serono, Pfizer, and Nektar. F. Fofana: Employee: Mapi Group. M. Schlichting, M. Bharmal: Employee: Merck KGaA. M. Henry-Szatkowski: Employee: Mapi Group; Paid consultant: Merck KGaA. M. Hennessy: Employee, Financial interest: EMD Serono.
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