New England Journal of Medicine Publishes Cemiplimab Trial Results in Advanced Cutaneous Squamous Cell Carcinoma[1]

GUILDFORD, England, June 5, 2018 /PRNewswire/ --

• Patients treated with cemiplimab experienced robust anti-tumour effects[1]
• Data also presented today at the 2018 ASCO Annual Meeting[2],[3]
• Cemiplimab applications under review by regulatory authorities in the U.S. and the EU; if licensed, would be the first anti-PD-1 available for advanced cutaneous squamous cell carcinoma in the UK

The New England Journal of Medicine (NEJM) today published pivotal data from two trials evaluating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC).[1]  The results were also presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. [2],[3] Advanced CSCC, a very serious non-melanoma skin cancer,[4] encompasses both patients with metastatic CSCC and those with locally advanced CSCC who are not candidates for surgery: there is currently no approved treatment for these patients. Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1 (programmed cell death protein 1).

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"Advanced CSCC is a very serious condition that currently has no approved treatments once surgery is no longer an option," said Dr Kent Yip, Consultant Clinical Oncologist, The Ipswich Hospital, Ipswich NHS Trust. "Understanding the safety and effectiveness of potential new treatments for advanced CSCC is welcome progress in an area of cancer which has a high unmet need and poor patient prognosis."

Pivotal CSCC trials provide a substantial prospective data set in this advanced cancer[2]

Data published in NEJM and/or presented at ASCO, and confirmed by independent central review, include: 

• Phase 2 EMPOWER-CSCC-1 trial     
  ο Cemiplimab-treated patients had a 47.5 percent response rate (28 of 59 patients, including 4 complete responses and 24 partial responses [PRs]) with a median observed time to response of 2 months as of the data cut-off date. [1] The durable disease control rate (DCR) was 61 percent (36 of 59 patients) and was defined as the proportion of patients without progressive disease for at least 105 days.[1]
  ο The median duration of response (DOR), median progression-free survival, and median overall survival have not been reached as of the data cut-off date (median follow-up for all patients: 8 months).[1] Of the responding patients, 82 percent remained in response and continued on cemiplimab.[1] The estimated progression-free probability at 12 months was 52.5 percent and the estimated probability of survival at 12 months was 81 percent.[1]
  ο The most common treatment-emergent adverse events were diarrhoea (27 percent), fatigue (24 percent), nausea (17 percent), constipation and rash (each 15 percent).[1] Grade 3 or higher adverse events regardless of attribution were reported in 25 patients (42 percent), of whom seven (12 percent) were considered related to treatment.[1] Three patients (5 percent) had adverse events with the outcome of death; however, none were considered related to treatment.[1]
  ο Data are from 59 metastatic CSCC patients who received cemiplimab (3 mg/kg every 2 weeks) for up to 96 weeks.[1]
• CSCC expansion cohorts of Phase 1 trial
  ο Cemiplimab-treated patients had a response rate of 50 percent (13 of 26 patients, all of which were PRs) with a median observed time to response of 2 months as of the data cut-off date. The durable DCR was 65 percent (17 of 26 patients).[1] The median DOR has not been reached as of the data cut-off date (median follow-up for all patients: 11 months).[1]
  ο The most common treatment-emergent adverse events of any grade were fatigue (27 percent), constipation, decreased appetite, diarrhoea, hypercalcaemia, hypophosphatemia, nausea and urinary tract infection (each 15 percent).[1]Grade 3 or higher adverse events regardless of attribution were reported in 12 patients (46 percent), of which five (19 percent) were considered related to treatment.[1] Two patients (8 percent) had adverse events related to treatment that led to treatment discontinuation.[1]
  ο Data are from 26 advanced CSCC patients who participated in two Phase 1 expansion cohorts and received cemiplimab (3 mg/kg every 2 weeks) for up to 48 weeks.[1] Patients either had metastatic CSCC or locally advanced CSCC who were not candidates for surgery.[1]

These findings formed part of the data set used for regulatory applications for cemiplimab as a potential treatment for advanced CSCC. These applications were accepted earlier this year for priority review by the U.S. Food and Drug Administration (FDA) and review by the European Medicines Agency (EMA). The FDA  target action date is October 28, 2018, and the EMA review process is expected to be complete by the first half of 2019. Regulatory applications in additional countries are also being considered for submission later in 2018. There are currently no FDA-approved or EMA-licensed treatments for patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.

Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Cemiplimab is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.

About CSCC

CSCC is the second most common type of skin cancer in the UK, accounting for approximately 23 percent of non-melanoma skin cancers.[5] The incidence of non-melanoma skin cancer is known to be rising and is estimated to do so until 2040. [6] Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced; these patients have a poor prognosis with a median overall survival of less than 2years.[7] Advanced CSCC is a very serious form of non-melanoma skin cancer.[4]

About Sanofi

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For more information, please visit http://www.sanofi.co.uk

References:

1. Migden_Rischin et al_ PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma. N Engl J Med 2018; DOI: 10.1056/NEJMoa1805131.

2. Rischin D, Migden MR, Chang A et al. Primary analysis of phase 2 results for cemiplimab, a human monoclonal anti-PD-1, in patients with metastatic cutaneous squamous cell carcinoma (mCSCC). American Society of Clinical Oncology 2019, Chicago, Illinois. 1-5 June 2018.

3. Owonikoko TK, Papadopoulos [http://ascopubs.org/author/Papadopoulos%2C+Kyriakos+P ] KP, Johnson M et al. Phase 1 study of cemiplimab, a human monoclonal anti-PD-1, in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Final efficacy and safety data. American Society of Clinical Oncology 2019, Chicago, Illinois. 1-5 June 2018.

4. Burton KA, Ashack KA, Khachemoune A. Cutaneous squamous cell carcinoma: a review of high-risk and metastatic disease [published online June 29, 2016]. Am J Clin Dermatol. 2016;17(5):491-508. doi:10.1007/s40257-016-0207-3.

5. NIHR Innovation Observatory Evidence Briefing: October 2017. Cemiplimab for advanced cutaneous squamous cell carcinoma - first line. Available at: http://www.io.nihr.ac.uk/wp-content/uploads/migrated_new/12662-Cemiplimab-for-advanced-cSCC.pdf (Accessed June 2018).

6. Newlands C, Currie R, Memon A, et al. Non‐melanoma skin cancer: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016; 130(2); 125‐132. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4873942/ [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4873942 ] (Accessed June 2018).

7. Stratigos A, Garbe C, Lebbe C, et al. On behalf of the European Dermatology Forum (EDF) the European Association of Dermato‐Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). Diagnosis and treatment of invasive squamous cell carcinoma of the skin: European consensus‐based interdisciplinary guideline. Eur J Cancer. 2015;51(14):1989-2007. Available at: http://www.eado.org/medias/Content/Files/2015‐Stratigos‐EurGuidelineSCC‐EJC.pdf  (Accessed June 2018).