Abstract 1148P
Background
Avelumab has been approved worldwide for the tx of mMCC based on results from the JAVELIN Merkel 200 trial. The French Health Technology Assessment Agency requested the collection of real-world data from pts with mMCC from a comprehensive registry; data for overall survival (OS), tx patterns, and time to tx failure (TTF) with 2L+ avelumab are reported here.
Methods
This retrospective noninterventional study evaluated pts with mMCC in France using 2 databases: CARADERM (French national database of rare dermatologic cancers) and Système National des Données de Santé (SNDS; national healthcare database). Pts with mMCC who initiated 2L+ avelumab outside a clinical trial between Aug 2016 and Dec 2019 were eligible. Pts were followed up for 24 months from start of avelumab. TTF was defined as time from avelumab initiation to discontinuation for any reason, including progression, toxicity, or death.
Results
180 pts received 2L+ avelumab, including 112 pts in the CARADERM database and 68 additional pts after SNDS linkage. Median age at diagnosis was 74.0 years; 66.7% of pts were male, and 98.3% had received first-line (1L) chemotherapy alone. The most common 1L tx in evaluable pts (CARADERM database) were cisplatin or carboplatin + etoposide (59.6%) and etoposide alone (12.8%). Median follow-up was 13.1 months. Median OS from start of 2L+ avelumab was 14.6 months (95% CI, 9.9-21.3 months). Of the evaluable pts (n=175) at the last follow-up, 9.1% were receiving avelumab, 31.4% had discontinued tx, and 57.1% had died; 2.3% were lost to follow-up. Median TTF was 8.5 months (95% CI, 6.2-10.5 months) overall; in CARADERM and non-CARADERM database pts, median TTF was 9.9 months (95% CI, 6.5-14.3 months) and 6.5 months (96% CI, 4.4-9.5 months), respectively. 12- and 24-month rates of pts without tx failure were 38.9% (95% CI, 31.6%-46.1%) and 15.5% (95% CI, 10.4%-21.4%), respectively. In evaluable pts who discontinued avelumab (CARADERM only), 30.3% received no subsequent tx, 50.6% received chemotherapy alone, and 19.1% received other tx.
Conclusions
These data provide insights into tx patterns among pts with mMCC receiving 2L+ avelumab in routine clinical practice in France.
Clinical trial identification
Editorial acknowledgement
Medical writing support was provided by Eleanor Bishop on behalf of Clinical Thinking and was funded by Merck and Pfizer.
Legal entity responsible for the study
The authors.
Funding
This study was sponsored by Merck Santé S.A.S., Lyon, France, an affiliate of Merck KGaA (CrossRef Funder ID: 10.13039/100009945), as part of an alliance between Merck and Pfizer.
Disclosure
A. Blom Fily: Financial Interests, Personal, Other, travel and accommodation expenses: Merck; Financial Interests, Personal, Advisory Role: Merck. L. Mortier: Financial Interests, Personal, Other, travel and accommodation expenses: Bristol Myers Squibb; Novartis, Roche/Genentech. B. van Hille: Financial Interests, Personal, Full or part-time Employment: Merck Santé S.A.S., Lyon, France, an affiliate of Merck KGaA. M. Samimi: Financial Interests, Personal, Invited Speaker, received fees for speaking at educational meetings: Amgen; Financial Interests, Personal, Invited Speaker, received fees for speaking at educational meetings: Novartis; Financial Interests, Personal, Advisory Board: Merck, Pfizer; Financial Interests, Personal, Other, travel and accommodation expenses: AbbVie, Amgen SAS, Bristol Myers Squibb, Celgene SAS, Galderma International, Janssen Cilag, Lilly France SAS, MSD, Pierre Fabre Médicaments France, Sanofi-Aventis. L. Luciani, C. Cahuzac: Financial Interests, Personal, Full or part-time Employment: Merck Santé S.A.S., Lyon, France, an affiliate of Merck KGaA. C. Robert: Financial Interests, Personal, Advisory Role: Roche, Novartis, Bristol Myers Squibb, MSD, Pierre Fabre, Sanofi, AstraZeneca, Sun Pharma; Financial Interests, Personal, Other, Co-founder: Ribonexus. E. Maubec: Financial Interests, Personal, Advisory Board: Pierre Fabre, Sanofi, Novartis; Financial Interests, Personal, Other, Travel and Accommodation Expenses: MSD, Pierre Fabre, Novartis; Financial Interests, Personal, Funding: MSD. F. Aubin: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Novartis, Sanofi, MSD, AbbVie, Janssen-Cilag, Leo Pharma, Amgen, Celgene. M. Solbes: Financial Interests, Personal, Full or part-time Employment: Merck Santé S.A.S., Lyon, France, an affiliate of Merck KGaA. I. Kachaner: Financial Interests, Personal, Full or part-time Employment: Pfizer. C. Lebbe: Financial Interests, Personal, Other, Honoraria: Amgen, Bristol Myers Squibb, Incyte, MSD, Novartis, Pfizer, Pierre Fabre, Roche; Financial Interests, Personal, Advisory Role: Amgen, Bristol Myers Squibb, MSD, Novartis, Roche; Financial Interests, Personal, Speaker’s Bureau: Amgen, Bristol Myers Squibb, Novartis, Roche; Financial Interests, Personal, Research Grant: Bristol Myers Squibb, Roche; Financial Interests, Personal, Other, Travel and Accommodation Expenses: Bristol Myers Squibb; Financial Interests, Personal, Other: Avantis Medical Systems. C. Dutriaux: Financial Interests, Personal, Advisory Board, Honoraria: MSD, Bristol Myers Squibb, Novartis, Pierre Fabre, Sun Pharma. P. Saiag: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, MSD, Pierre Fabre, Novartis, Roche/Genentech, Sanofi; Financial Interests, Personal, Other, Travel and accommodation expenses: Pierre Fabre, Novartis, Bristol Myers Squibb, MSD; Financial Interests, Personal, Research Funding: Pierre Fabre. All other authors have declared no conflicts of interest.
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