First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study
Background Avelumab (anti-programmed death ligand 1 (PD-L1)) is approved in multiple countries for the treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. We report efficacy and safety data and exploratory biomarker analyses from a cohort of patients with mMCC tr...
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| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2021
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| In: |
Journal for ImmunoTherapy of Cancer
Year: 2021, Volume: 9, Issue: 7, Pages: 1-10 |
| ISSN: | 2051-1426 |
| DOI: | 10.1136/jitc-2021-002646 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1136/jitc-2021-002646 Verlag, lizenzpflichtig, Volltext: https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=DynamicDOIArticle&SrcApp=WOS&KeyAID=10.1136%2Fjitc-2021-002646&DestApp=DOI&SrcAppSID=E3EMe27mBXhMkfROGJN&SrcJTitle=JOURNAL+FOR+IMMUNOTHERAPY+OF+CANCER&DestDOIRegistrantName=BMJ 
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| Author Notes: | Sandra P. D'Angelo, Celeste Lebbe, Laurent Mortier, Andrew S. Brohl, Nicola Fazio, Jean-Jacques Grob, Natalie Prinzi, Glenn J. Hanna, Jessica C. Hassel, Felix Kiecker, Sara Georges, Barbara Ellers-Lenz, Parantu Shah, Gulseren Guezel, Paul Nghiem |
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| 245 | 1 | 0 | |a First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200) |b primary and biomarker analyses of a phase II study |c Sandra P. D'Angelo, Celeste Lebbe, Laurent Mortier, Andrew S. Brohl, Nicola Fazio, Jean-Jacques Grob, Natalie Prinzi, Glenn J. Hanna, Jessica C. Hassel, Felix Kiecker, Sara Georges, Barbara Ellers-Lenz, Parantu Shah, Gulseren Guezel, Paul Nghiem |
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| 520 | |a Background Avelumab (anti-programmed death ligand 1 (PD-L1)) is approved in multiple countries for the treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. We report efficacy and safety data and exploratory biomarker analyses from a cohort of patients with mMCC treated with first-line avelumab in a phase II trial. Methods Patients with treatment-naive mMCC received avelumab 10 mg/kg intravenously every 2 weeks. The primary endpoint was durable response, defined as objective response (complete or partial response; assessed by independent review) lasting >= 6 months. Additional assessments included progression-free survival (PFS), overall survival (OS), safety, and biomarker analyses. Results In 116 patients treated with avelumab, median follow-up was 21.2 months (range: 14.9-36.6). Thirty-five patients had a response lasting >= 6 months, giving a durable response rate of 30.2% (95% CI: 22.0% to 39.4%). The objective response rate was 39.7% (95% CI: 30.7% to 49.2%). Median PFS was 4.1 months (95% CI: 1.4 to 6.1) and median OS was 20.3 months (95% CI: 12.4 to not estimable). Response rates were numerically higher in patients with PD-L1+ tumors, Merkel cell polyomavirus (MCPyV)-negative tumors, and tumors with increased intratumoral CD8(+) T-cell density. Exploratory analyses did not identify a biomarker that could reliably predict a response to first-line treatment with avelumab; however, a novel gene expression signature to identify the presence of MCPyV+ tumors was derived. Treatment-related adverse events (any grade) occurred in 94 (81.0%) patients, including grade 3/4 events in 21 (18.1%) patients; no treatment-related deaths occurred. Conclusion In patients with mMCC, first-line treatment with avelumab led to responses in 40% and durable responses in 30%, and was associated with a low rate of grade 3/4 treatment-related adverse events. | ||
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