High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma Article Swipe
Danny Rischin
,
Brett Hughes
,
Nicole Basset‐Séguin
,
Dirk Schadendorf
,
Samantha Bowyer
,
Sabiha Trabelsi Messai
,
Friedegund Meier
,
Thomas Eigentler
,
V. Casado Echarren
,
Brian Stein
,
M. Beylot‐Barry
,
S. Dalac
,
Brigitte Dréno
,
Michael R. Migden
,
Axel Hauschild
,
Chrysalyne D. Schmults
,
Annette M. Lim
,
Suk‐Young Yoo
,
Anne Paccaly
,
Apostolos Papachristos
,
Jenny‐Hoa Nguyen
,
Emmanuel Chiebuka Okoye
,
Frank Seebach
,
Jocelyn Booth
,
Israel Lowy
,
Matthew G. Fury
,
Alexander Guminski
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1136/jitc-2023-008325
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1136/jitc-2023-008325
Background Cemiplimab (Libtayo ® ), a human monoclonal immunoglobulin G4 antibody to the programmed cell death-1 receptor, is approved for the treatment of patients with advanced cutaneous squamous cell carcinoma (CSCC), who are not candidates for curative surgery or curative radiation, using an every-3-weeks (Q3W) dosing interval. Pharmacokinetic modeling indicated that C trough of extended intravenous dosing of 600 mg every 4 weeks (Q4W) would be comparable to the approved intravenous dosage of 350 mg Q3W. We examined the efficacy, pharmacokinetics, and safety of cemiplimab dosed Q4W. Methods In this open-label, phase II trial (ClinicalTrials.gov identifier NCT02760498 ), the cohort of patients ≥18 years old with advanced CSCC received cemiplimab 600 mg intravenously Q4W for up to 48 weeks. Tumor measurements were recorded every 8 weeks. The primary endpoint was objective response rate by independent central review. Results Sixty-three patients with advanced CSCC were treated with cemiplimab. The median duration of follow-up was 22.4 months (range: 1.0–39.8). An objective response was observed in 39 patients (62%; 95% CI: 48.8% to 73.9%), with 22% of patients (n = 14) achieving complete response and 40% (n = 25) achieving partial response. The most common treatment-emergent adverse events were diarrhea, pruritus, and fatigue. Conclusions Extended dosing of cemiplimab 600 mg intravenously Q4W exhibited substantial antitumor activity, rapid and durable responses, and an acceptable safety profile in patients with advanced CSCC. These results confirm that cemiplimab is a highly active therapy for advanced CSCC. Additional data would help ascertain the benefit−risk profile for the 600 mg intravenous dosing regimen compared with the approved regimen.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/jitc-2023-008325
- https://jitc.bmj.com/content/jitc/12/3/e008325.full.pdf
- OA Status
- gold
- Cited By
- 7
- References
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- Related Works
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- OpenAlex ID
- https://openalex.org/W4392710900
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4392710900Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1136/jitc-2023-008325Digital Object Identifier
- Title
-
High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinomaWork title
- Type
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articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-03-01Full publication date if available
- Authors
-
Danny Rischin, Brett Hughes, Nicole Basset‐Séguin, Dirk Schadendorf, Samantha Bowyer, Sabiha Trabelsi Messai, Friedegund Meier, Thomas Eigentler, V. Casado Echarren, Brian Stein, M. Beylot‐Barry, S. Dalac, Brigitte Dréno, Michael R. Migden, Axel Hauschild, Chrysalyne D. Schmults, Annette M. Lim, Suk‐Young Yoo, Anne Paccaly, Apostolos Papachristos, Jenny‐Hoa Nguyen, Emmanuel Chiebuka Okoye, Frank Seebach, Jocelyn Booth, Israel Lowy, Matthew G. Fury, Alexander GuminskiList of authors in order
- Landing page
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https://doi.org/10.1136/jitc-2023-008325Publisher landing page
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https://jitc.bmj.com/content/jitc/12/3/e008325.full.pdfDirect link to full text PDF
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://jitc.bmj.com/content/jitc/12/3/e008325.full.pdfDirect OA link when available
- Concepts
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Dosing, Basal cell, Medicine, Dermatology, Oncology, Internal medicine, Cancer researchTop concepts (fields/topics) attached by OpenAlex
- Cited by
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7Total citation count in OpenAlex
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2025: 5, 2024: 2Per-year citation counts (last 5 years)
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21Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.patients | 23, 101, 139, 164, 174, 223 |
| abstract_inverted_index.received | 108 |
| abstract_inverted_index.recorded | 122 |
| abstract_inverted_index.regimen. | 259 |
| abstract_inverted_index.response | 131, 159, 180 |
| abstract_inverted_index.squamous | 27 |
| abstract_inverted_index.achieving | 178, 186 |
| abstract_inverted_index.activity, | 212 |
| abstract_inverted_index.antitumor | 211 |
| abstract_inverted_index.ascertain | 244 |
| abstract_inverted_index.carcinoma | 29 |
| abstract_inverted_index.cutaneous | 26 |
| abstract_inverted_index.diarrhea, | 196 |
| abstract_inverted_index.efficacy, | 79 |
| abstract_inverted_index.exhibited | 209 |
| abstract_inverted_index.follow-up | 151 |
| abstract_inverted_index.indicated | 49 |
| abstract_inverted_index.interval. | 46 |
| abstract_inverted_index.objective | 130, 158 |
| abstract_inverted_index.pruritus, | 197 |
| abstract_inverted_index.receptor, | 16 |
| abstract_inverted_index.response. | 188 |
| abstract_inverted_index.treatment | 21 |
| abstract_inverted_index.Additional | 240 |
| abstract_inverted_index.Background | 0 |
| abstract_inverted_index.Cemiplimab | 1 |
| abstract_inverted_index.acceptable | 219 |
| abstract_inverted_index.candidates | 34 |
| abstract_inverted_index.cemiplimab | 84, 109, 204, 231 |
| abstract_inverted_index.comparable | 66 |
| abstract_inverted_index.identifier | 95 |
| abstract_inverted_index.monoclonal | 7 |
| abstract_inverted_index.programmed | 13 |
| abstract_inverted_index.radiation, | 40 |
| abstract_inverted_index.responses, | 216 |
| abstract_inverted_index.Conclusions | 200 |
| abstract_inverted_index.NCT02760498 | 96 |
| abstract_inverted_index.Sixty-three | 138 |
| abstract_inverted_index.cemiplimab. | 146 |
| abstract_inverted_index.independent | 134 |
| abstract_inverted_index.intravenous | 55, 70, 252 |
| abstract_inverted_index.open-label, | 90 |
| abstract_inverted_index.substantial | 210 |
| abstract_inverted_index.1.0–39.8). | 156 |
| abstract_inverted_index.measurements | 120 |
| abstract_inverted_index.every-3-weeks | 43 |
| abstract_inverted_index.intravenously | 112, 207 |
| abstract_inverted_index.benefit−risk | 246 |
| abstract_inverted_index.immunoglobulin | 8 |
| abstract_inverted_index.Pharmacokinetic | 47 |
| abstract_inverted_index.pharmacokinetics, | 80 |
| abstract_inverted_index.treatment-emergent | 192 |
| abstract_inverted_index.(ClinicalTrials.gov | 94 |
| cited_by_percentile_year.max | 98 |
| cited_by_percentile_year.min | 94 |
| countries_distinct_count | 7 |
| institutions_distinct_count | 27 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.7400000095367432 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.93042136 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |