1145P - Clinical characteristics and survival of patients with advanced Merkel cell carcinoma (MCC) treated with avelumab: Analysis of a prospective German MCC registry (MCC TRIM)

Background

MCC is a rare and aggressive form of skin cancer. Avelumab was the first immunotherapy approved for adult patients with metastatic MCC in Europe. We investigated the clinical characteristics and survival outcomes of patients with MCC at the start of and after avelumab treatment.

Methods

Data from 684 patients in a prospective, noninterventional, multicenter, dynamic cohort of the MCC TRIM study who were enrolled after March 2019 were analyzed. Primary data from a study-specific electronic case report form and secondary data from the German national skin cancer registry ADOReg were combined. At data cutoff (Sept 30, 2022), patients diagnosed with unresectable stage III or IV MCC prior to avelumab treatment were included in this analysis. Survival outcomes were assessed by the Kaplan-Meier method.

Results

Of 116 patients with MCC receiving avelumab, 35.3% had stage III disease and 64.7% had stage IV. The mean (SD) age at initial diagnosis was 74.5 (10.4) y, and 62.1% of patients were male. Most patients had an Eastern Cooperative Oncology Group performance status ≤1 (76.7%); 21.6% had an immunosuppressive condition or took immunosuppressive medication. Diabetes was the most common comorbidity (23.3%). At a median follow-up of 28.75 mo (95% CI, 20.5-32.5 mo), median overall survival (OS) was not reached in stage III patients and was 52.0 mo (95% CI, 15.4 mo-not estimable [NE]) in stage IV patients. Median (95% CI) progression-free survival (PFS) was 11.8 mo (5.6 mo-NE) in stage III patients and 9.3 mo (3.5-13.7 mo) in stage IV patients. Most patients (86.2%) received avelumab as first-line (1L) therapy; of these, 37.0% had stage III disease and 63.0% had stage IV. Median OS with 1L avelumab was not reached in the stage III or IV group, but fewer events were observed in stage III vs stage IV patients (16.2% vs 36.5%); median PFS (95% CI) was 15.6 mo (5.6 mo-NE) and 7.3 mo (3.0-13.7 mo), respectively.

Conclusions

Demographics observed in MCC TRIM reflect those of the typical advanced MCC population. This nationwide study indicates that avelumab is effective in stage III and IV patients with advanced MCC in routine clinical practice.

Clinical trial identification

Editorial acknowledgement

Editorial support was provided by Alana Reed 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 (CrossRef Funder ID: 10.13039/100009945), as part of an alliance between Merck and Pfizer.

Disclosure

J.C. Becker: Financial Interests, Personal, Speaker’s Bureau: Amgen, Merck Serono, Pfizer, Recordati, Sanofi; Financial Interests, Personal, Advisory Board: Almirall, Boehringer Ingelheim, InProTher, ICON, Pfizer, 4SC, Sanofi/Regeneron; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, Merck Serono, HTG, IQVIA, Alcedis. S. Mahmoudpour: Financial Interests, Personal, Full or part-time Employment: Merck Healthcare KGaA, Darmstadt, Germany. D. Schadendorf: Financial Interests, Personal, Invited Speaker: BMS, Merck, Novartis, Roche, Sanofi; Financial Interests, Personal, Advisory Board: BMS, Immunocore, MSD, Neracare, Novartis, Pfizer, Philogen, Pierre Fabre, Sanofi/Regeneron; Financial Interests, Personal, Leadership Role: MSD; Financial Interests, Institutional, Research Grant: BMS, MSD; Financial Interests, Personal, Steering Committee Member: BMS, MSD, Novartis; Non-Financial Interests, Personal, Coordinating PI: BMS, Novartis; Financial Interests, Personal, Coordinating PI: MSD; Non-Financial Interests, Personal, Local PI: Philogen; Non-Financial Interests, Institutional, Coordinating PI: Pierre Fabre; Non-Financial Interests, Institutional, Local PI: Sanofi; Non-Financial Interests, Institutional, Member of Board of Directors: EORTC-MG. U. Leiter-Stoppke: Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal and Institutional, Other, Lecturing: Roche, Novartis, Sanofi, MSD, Sun Pharma; Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, Sanofi, MSD, Novartis, Sun Pharma, Allmiral Hermal. F. Meier: Financial Interests, Personal, Other, received travel support or/and speaker’s fees or/and advisor’s honoraria: Novartis, Roche, Bristol Myers Squibb, MSD, Pierre Fabre, Sanofi, Immunocore; Financial Interests, Institutional, Research Funding: Novartis, Roche. R. Herbst: Financial Interests, Personal, Full or part-time Employment: Helios Klinikum Erfurt GmbH; Erfurt, Germany. M. Sachse: Financial Interests, Personal, Speaker, Consultant, Advisor: Novartis; Financial Interests, Personal, Advisory Board: Sanofi Genzyme. S. Grabbe: Financial Interests, Institutional, Research Grant: Novartis, Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau: Sun Pharma; Financial Interests, Personal, Speaker, Consultant, Advisor: Klinge Pharma, Novartis, Kyowa Kirin, BMS, MSD; Financial Interests, Personal, Other, Support for attending meetings and/or travel: UCB. C. Gebhardt: Financial Interests, Personal, Advisory Board: Almirall, Beiersdorf, Bristol Myers Squibb, Immunocore, Janssen, MSD, Novartis, Pierre Fabre Pharma, Sanofi Genzyme, Sun Pharma and Sysmex; Financial Interests, Institutional, Research Funding: Novartis, Sanofi Genzyme; Financial Interests, Personal, Other, travel support: Bristol Myers Squibb, Pierre Fabre Pharma, Sun Pharma; Financial Interests, Personal, Other, co-founder: Dermagnostix R&D. F. Ziller: Financial Interests, Personal, Advisory Board, Honoraria and/or travel support: Bristol Myers Squibb, MSD, Roche, Novartis, Pierre Fabre, Sanofi, Sun Pharma. P. Mohr: Financial Interests, Institutional, Research Grant: MSD, BMS, Novartis Pharmaceuticals, Amgen Inc., Beiersdorf, Pierre Fabre, Almirall Hermal, Immunocore LLC, Merck, Novartis Pharmaceuticals, Pfizer, Sun Pharma, Sanofi Genzyme, Regeneron Pharmaceuticals; Financial Interests, Personal, Advisory Board: BMS, MSD, Pierre Fabre, Sun Pharma, Sanofi Genzyme, Novartis, Amgen Inc.; Financial Interests, Personal, Other, travel support/accommodations: Pierre Fabre, BMS, MSD, Novartis, Sun Pharma; Financial Interests, Personal, Other, Leadership or fiduciary role in other board, society, committee or advocacy group: MID Melanom Info Deutschland. L. Zimmer: Financial Interests, Personal, Other, Honoraria: MSD, BMS, Pierre Fabre, Novartis; Financial Interests, Personal, Other, Support for attending meetings and/or travel: BMS, Novartis, Sun Pharma, Pierre Fabre; Financial Interests, Personal, Other, SuppoSupport for attending meetings and/or travel rt for attending meetings and/or travel from: MSD; Financial Interests, Personal, Advisory Board: BMS, MSD, Pierre Fabre, Novartis; Financial Interests, Personal, Leadership Role: Cancer Survivorship Committee; Non-Financial Interests, Personal, Leadership Role: DeCOG; Financial Interests, Other, Receipt of equipment, materials, drugs, medical writing, gifts or other services: Merck. E. Boutmy: Financial Interests, Personal, Full or part-time Employment: Merck. S. Hoff: Financial Interests, Personal, Full or part-time Employment: Merck Healthcare KGaA, Darmstadt, Germany. P. Verpillat: Financial Interests, Personal, Full or part-time Employment, at time of study: Merck. A. Fernandez Milano, C. Fu: Financial Interests, Personal, Full or part-time Employment: IQVIA Commercial GmbH & Co. OHG, Frankfurt am Main, Germany. M. Shlaen: Financial Interests, Personal, Financially compensated role: IQVIA Commercial GmbH & Co. OHG, Frankfurt am Main, Germany. S. Ugurel-Becker: Financial Interests, Institutional, Research Grant: BMS, Merck; Financial Interests, Personal, Advisory Board: BMS, MSD, Merck, Novartis; Financial Interests, Personal, Other, travel support: BMS, MSD, Pierre Fabre. All other authors have declared no conflicts of interest.