Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial

Abstract

DR recruited patients and collected the data. SL did the data analysis. All authors contributed to data interpretation, as well as critical review, revision, and approval of the report. Data sharingQualified researchers can request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this report. Individual anonymised participant data will be made available once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Requests should be submitted on the Regeneron website.

Update on the anti‐programmed cell death‐1 receptor antibodies in advanced cutaneous squamous‐cell carcinoma

“…The data from the Phase 2 study of 78 patients with locally advanced cSCC have just been published in January 2020 in Lancet Oncology 6 . The median duration of study follow‐up was 9.3 months (IQR 5.1‐15.7) at the time of data cutoff.…”

Novel treatments using PD1 inhibitors for advanced and metastatic cutaneous squamous cell carcinoma

“…The most common therapeutic regimens are chemotherapy and epidermal growth factor receptor (EGFR) inhibitors [1][2][3]. However, some studies have reported the low efficacy of cytotoxic chemotherapies (cisplatin, 5-fluorouracil (5-FU), bleomycin, and doxorubicin) and EGFR inhibitors [4,5]. Due to the fact that cutaneous SCC in the advanced stage has limited response to common therapies, investigations into systematic therapies with better response rates are crucial [6,7].…”

Where do we stand with immune checkpoint blockade for advanced cutaneous squamous cell carcinoma? A systematic review and critical appraisal of the existing evidence

“…Four prospective phase II studies and one phase I study were identified. [3][4][5][6][7][8] The remaining records included one expanded-access programme, two retrospective analyses and 22 case reports or series. The number of patients per study ranged from one to 137.…”

“…We identified results for cemiplimab (six records), pembrolizumab (19 records), nivolumab (nine records), combined ipilimumab with nivolumab (one record) and ipilimumab (one record). The ORR ranged from 36% to 55% 3,4 for pembrolizumab and from 44% to 49% [6][7][8] for cemiplimab ( Table 1). Severe adverse events were observed in 23-29Á5% of the patients treated with cemiplimab, but they were poorly reported for other agents.…”

“…Cemiplimab and pembrolizumab appear to be the most evidencebased substances in this setting, as they yielded response rates consistently from 40% to 55% and were investigated in methodological studies of higher quality. [3][4][5][6][7][8] We also contacted the authors of the included studies, who consistently confirmed the use of cemiplimab as the current standard of care for advanced cSCC. Other agents of ICB also showed promising clinical results with objective and durable responses.…”