Evidence map›Paper›PMID 34413166›Full record

Trial reportJournal for immunotherapy of cancer2021

Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis.

Danny Rischin, Nikhil I Khushalani, Chrysalyne D Schmults, Alexander Guminski, Anne Lynn S Chang, Karl D Lewis, Annette M Lim, Leonel Hernandez-Aya, Brett G M Hughes, Dirk Schadendorf and 14 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02760498 (A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1), which is not on this map. Cited by 65 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02760498 phase2completednot on this map

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2016 to 2023Enrolled432ConditionsAdvanced Cutaneous Squamous Cell CarcinomaArmscemiplimab
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Phase II (Alliance A091802) Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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  7. Article
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  9. Review
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  17. Patient Perspectives of Quality Compared to Quantity of Life Regarding Orbital Exenteration.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2025
    Article
  18. Article
  19. Managing Advanced Squamous Cell Carcinoma: A Guide for the Dermatology Clinician.The Journal of clinical and aesthetic dermatology · 2025
    Review
  20. Review

5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Danny RischinDepartment of Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia danny.rischin@petermac.org.
Nikhil I KhushalaniDepartment of Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Chrysalyne D SchmultsDepartment of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Alexander GuminskiDepartment of Medical Oncology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.ORCID 0000-0003-3681-7015
Anne Lynn S ChangDepartment of Dermatology, Stanford University School of Medicine, Redwood City, California, USA.
Karl D LewisDepartment of Medicine, Division of Medical Oncology, University of Colorado Cancer Center, Aurora, Colorado, USA.
Annette M LimDepartment of Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia.
Leonel Hernandez-AyaDepartment of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Brett G M HughesDepartment of Cancer Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane, Queensland, Australia.
Dirk SchadendorfDepartment of Dermatology, University Hospital Essen; German Cancer Consortium, Essen, Germany.
Axel HauschildDepartment of Dermatology, Schleswig-Holstein University Hospital, Kiel, Germany.
Alesha A ThaiDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Elizabeth StankevichRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Jocelyn BoothRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Suk-Young YooRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Siyu LiRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Zhen ChenRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Emmanuel OkoyeRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Chieh-I ChenRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Vera MasteyRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Medha SasaneSanofi, Bridgewater Township, New Jersey, USA.
Israel LowyRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Matthew G FuryRegeneron Pharmaceuticals, Tarrytown, New York, USA.
Michael R MigdenDepartments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL).

methodsPatients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 weeks; group 3: 9 weeks).

resultsMedian duration of follow-up was 15.7 months. Overall, ORR per ICR was 46.1% (95% CI: 38.9% to 53.4%). Complete response (CR) rates were 20.3%, 12.8%, and 16.1% for groups 1, 2, and 3, respectively. Median time to CR was 11.2 months. Among patients with partial response or CR, the estimated proportion of patients with ongoing response at 12 months from the first objective response was 87.8% (95% CI: 78.5% to 93.3%), with median DOR not reached. Kaplan-Meier estimated probability of overall survival (OS) was 73.3% (95% CI: 66.1% to 79.2%) at 24 months, with median OS not reached. Global Health Status (GHS)/QoL improvements were observed as early as cycle 2 and were significantly improved and durable until last assessment. Kaplan-Meier estimate of median time to first clinically meaningful improvement for pain was 2.1 (95% CI: 2.0 to 3.7) months and was significantly improved in responders versus non-responders (p<0.0001).

conclusionsThis is the largest (n=193) clinical dataset for a programmed cell death-1 inhibitor against advanced CSCC, confirming the sustained substantial clinical activity of cemiplimab in these patients, including new findings of improved CR rates over time, increasing DOR, and durable pain control and GHS/QoL improvement. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02760498), https://clinicaltrialsgov/ct2/show/NCT02760498.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedCarcinoma, Squamous CellFemaleFollow-Up StudiesHumansMaleMiddle AgedQuality of LifeSkin NeoplasmsTreatment OutcomeAntibodies, Monoclonal, Humanizedcemiplimabclinical trialsimmunotherapyphase II as topicprogrammed cell death 1 receptorskin neoplasms

Identifiers

PMID34413166
PMCPMC8382148

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.