Cemiplimab removed from reimbursable drugs in France

Pham, Félix; Reynaud, Bénédicte; Favier, Bertrand; Darnis, Sophie; Amini‐Adlé, Mona

doi:10.1016/j.ejca.2021.02.041

Cited by 2 publications

(2 citation statements)

References 7 publications

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“…This includes partial response rates ranging from 23% to 47% and CR rates ranging from 8% to 33%. [17][18][19][20][21][22][23][24] The DCR ranged from 47% to 72% in real-world studies, with a median of 62%. [18][19][20]24,25 Factors associated with higher response rates included age, 20 higher performance status, and primary tumors on the head and neck.…”

Section: Real World Efficacy Datamentioning

confidence: 99%

Cemiplimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma: Appropriate Patient Selection and Perspectives

Mager,

Gardeen,

Carr

et al. 2023

CCID

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Five percent of patients with cutaneous squamous cell carcinoma develop locally advanced or metastatic disease that is not amenable to definitive surgical or radiation therapy. Cemiplimab, an antibody against programmed death receptor-1, was approved in the United States for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma in 2018. We performed a literature review on the use of cemiplimab in cutaneous squamous cell carcinoma, with an emphasis on efficacy, safety and tolerability, patient selection, and future directions. Embase and PubMed were searched for relevant terms, and 23 peer-reviewed journal articles presenting primary data on cemiplimab treatment in 5 or more subjects with cutaneous squamous cell carcinoma were included and summarized. Objective response rates in locally advanced and metastatic disease ranged from 42.9% to 50.8% in Phase I/ II clinical trials and 32-77% (median 58%) in post-approval observational studies. Phase II trials looking at neoadjuvant use also had favorable response rates. Real-world studies demonstrated cemiplimab efficacy in periorbital tumors, tumors with large caliber perineural invasion, and tumors in solid organ transplant recipients. Cemiplimab was safe and well-tolerated in most patients. While side effects such as fatigue, diarrhea, pruritus, and rash were fairly common, only 9.8% of adverse events required cessation of therapy in phase II trials. Severe adverse events were primarily immune-mediated, including pneumonitis, myocarditis, myositis, and autoimmune hepatitis; the risk of treatment-related death was 3% in clinical trials. Further research on cemiplimab therapy in cutaneous squamous cell carcinoma is needed, and trials are now underway to obtain Phase IV long-term real-world data, further data on adjuvant and neoadjuvant use, and additional data in special populations such as stem cell and solid organ transplant recipients.

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Section: Real World Efficacy Datamentioning

confidence: 99%

Cemiplimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma: Appropriate Patient Selection and Perspectives

Mager,

Gardeen,

Carr

et al. 2023

CCID

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“…On 21 January 2021, cemiplimab was removed from France's list of reimbursable medicine specialties in view of the absence of phase III randomized trials demonstrating comparative or higher efficacy of cemiplimab versus other systemic treatments [69]. However, patient support programs are available in the United States of America.…”

Section: Pd-1 Inhibitorsmentioning

confidence: 99%

Recent Trends in the Integrated Management of Cutaneous Squamous Cell Carcinoma

Naik

2022

Dermato

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Cutaneous squamous cell carcinoma (cSCC) is one of the most prevalent neoplasms worldwide. Important risk factors for cSCC include sun exposure, immunosuppression, pale skin, and aging. White people are more likely to develop cSCC, and men are more affected than women. In advanced cases, surgery and/or radiotherapy are no longer effective. Due to a historical lack of treatment options, some medications have been used in these patients without sufficient recommendation. There is an urgent need to identify patients at an increased risk of recurrence and spread early for timely diagnosis and treatment. Despite extensive data on the high-risk features and prognostication, considerable variation remains globally regarding high-risk cSCC and the delivery of oncology services. The current comprehensive review evaluated and summarized contemporary knowledge of various management options for cSCC to simplify the integrated treatment plans.

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Cemiplimab removed from reimbursable drugs in France

Cited by 2 publications

References 7 publications

Cemiplimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma: Appropriate Patient Selection and Perspectives

Cemiplimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma: Appropriate Patient Selection and Perspectives

Recent Trends in the Integrated Management of Cutaneous Squamous Cell Carcinoma

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