Abstract 1090P
Background
MCC is a rare, aggressive skin cancer with high disease-associated mortality. The approval of immuno-oncology (IO) therapies has altered the standard of care and improved outcomes in pts with LA and mMCC. SPEAR-Merkel (Study informing treatment Pathway dEcisions in Merkel cell cARcinoma) assessed RW clinical outcomes in pts with LA and mMCC initiating first-line (1L) treatment with avelumab (A-IO), non-avelumab IO (NA-IO), or chemotherapy (C) in the community setting in the US.
Methods
Adult pts with LA or mMCC who began 1L treatment with A-IO, NA-IO, or C from 1 Jan 2017 to 31 Mar 2019 were identified from the US Oncology Network electronic healthcare record database and followed through 30 Sep 2019. Baseline characteristics and RW overall response rate (ORR) were analyzed descriptively. Kaplan-Meier methods were used to evaluate progression-free survival (PFS), overall survival (OS), and duration of therapy (DOT).
Results
The study included 94 pts (median age, 73 years; 68% male); 28 A-IO, 26 NA-IO, and 40 C. Median follow-up (months) was 11.2, 9.8, and 10.7 in A-IO, NA-IO, and C pts, respectively. The majority of pts were immunocompetent (>85%), and 29% had LA MCC prior to 1L treatment (A-IO, 32.%; NA-IO, 31%; C, 25%). Clinical outcomes are reported in the table.
Conclusions
This is the first RW study to examine outcomes in pts with LA or mMCC treated with A-IO or NA-IO. Although the sample size is small, this study suggests consistent outcomes in A-IO and NA-IO pts, slightly favoring A-IO. Response rates with IO were higher than with C, as determined by pivotal trials. These RW data suggest there may be an opportunity to improve outcomes for pts treated with C. Table: 1090P
| A-IO N=28 | NA-IO N=26 | C N=40 | |
| ORR (physician assessed)a | 64.3 (44.1-81.4) | 61.5 (40.6-79.8) | 42.5 (27.0-59.1) |
| Median PFSb | 11.4 (5.3-NR) | 8.1 (3.0-NR) | 6.1 (3.6-10.6) |
| PFS ratec | 67.9 (47.3-81.8) | 57.7 (36.8-73.9) | 50.0 (33.8-64.2) |
| Median OSb | 20.2 (11.1-NR) | NR (5.5-NR) | 14.7 (8.8-NR) |
| OS ratec | 85.7 (66.3-94.4) | 69.2 (47.8-83.3) | 77.5 (61.2-87.6) |
| Median DOTb | 10.5 (5.3-14.3) | 7.3 (2.5-18.2) | 2.2 (1.9-3.5) |
NR, not reached a (95% CI), % b (95% CI), months c (95% CI) at 6 months, %
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
EMD Serono, Inc.; a business of Merck KGaA, Darmstadt, Germany.
Funding
EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany, and is part of an alliance between Merck KGaA and Pfizer.
Disclosure
C.L. Cowey: Research grant/Funding (self): Bristol-Myers Squibb; Research grant/Funding (self): Merck & Co.; Research grant/Funding (self): Novartis; Research grant/Funding (self): EMD Serono, Inc.; Research grant/Funding (self): Amgen. F.X. Liu: Travel/Accommodation/Expenses, Full/Part-time employment: EMD Serono, Inc.; a business of Merck KGaA, Darmstadt, Germany; Shareholder/Stockholder/Stock options: Merck & Co. R. Kim: Full/Part-time employment: Pfizer Inc.; Shareholder/Stockholder/Stock options: Exelixis. M. Boyd, N. Fulcher: Full/Part-time employment: McKesson Life Sciences. S. Krulewicz: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer Inc. J. Smith: Leadership role, Research grant/Funding (self), Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: EMD Serono, Inc.; a business of Merck KGaA, Darmstadt, Germany. A. Bhanegaonkar: Full/Part-time employment: EMD Serono Research & Development Institute, Inc., Rockland, MA, USA; a business of Merck KGaA, Darmstadt, Germany.