Nikhil Khushalani, MD, on Immunotherapy in Advanced Unresectable CSCC
Thematic Newsreels
Nikhil Khushalani, MD, Vice Chair for the Department of Cutaneous Oncology at Moffitt Cancer Center, offers his thoughts on the role of immunotherapy in the treatment of advanced cutaneous squamous cell carcinoma (CSCC). Dr. Khushalani discusses the three currently approved immunotherapeutic agents for this disease—cemiplimab-rwlc, pembrolizumab, and cosibelimab-ipdl—and their confirmatory trials as well as adverse event profiles. He also talks about choosing optimal treatment strategies for patients, and studies currently exploring monotherapy vs combination therapy regimens.
References
1. Migden MR, Rischin D, Schmults CD, et al: PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Eng J Med 379:341-351, 2018.
2. Hughes BGM, Guminski A, Bowyer S, et al: A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6. J Am Acad Dermatol 1:68-77, 2025.
3. Grob JJ, Gonzalez R, Bassett-Seguin N, et al: Pembrolizumab monotherapy for recurrent or metastatic cutaneous squamous cell carcinoma: A single-arm phase II trial (KEYNOTE-629). J Clin Oncol 25:2916-2925, 2020.
4. Maubec E, Boubaya M, Petrow P, et al: Phase II study of pembrolizumab as first-line, single-drug therapy for patients with unresectable cutaneous squamous cell carcinomas. J Clin Oncol 26:3051-3061, 2020.
5. Clingan P, Ladwa R, Brungs D, et al: Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma. J Immunother Cancer 10:e007637, 2023.
6. Zandberg DP, Allred JB, Rosenberg AJ, et al: Phase II (Alliance A091802) randomized trial of avelumab plus cetuximab versus avelumab alone in advanced cutaneous squamous cell carcinoma. J Clin Oncol 43:2398-2408, 2025.
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References
- Gross ND, Miller DM, Khushalani NI, et al: Neoadjuvant cemiplimab for stage II to IV cutaneous squamous-cell carcinoma. N Eng J Med 387:1557-1568, 2022.
- Gross ND, Miller DM, Khushalani NI, et al: Neoadjuvant cemiplimab and surgery for stage II-IV cutaneous squamous-cell carcinoma: Follow-up and survival outcomes of a single-arm, multicentre, phase 2 study. Lancet Oncol 11:1196-1205, 2023.
- Breukers SE, Traets JJH, van Dijk SW, et al: Neoadjuvant ipilimumab and nivolumab in resectable cutaneous squamous cell carcinoma: A randomized phase 2 trial. Nature Medicine. October 8, 2025 (early release online).
- Ladwa R, Lee JH, McGrath M, et al: Response-adapted surgical and radiotherapy de-escalation in resectable cutaneous squamous cell cancer using pembrolizumab: The De-Squamate study. J Clin Oncol 26:2888-2986, 2025.
- Porceddu SV, Bressel M, Poulsen MG, et al: Postoperative concurrent chemoradiotherapy versus postoperative radiotherapy in high-risk cutaneous squamous cell carcinoma of the head and neck: The randomized phase III TROG 05.01 trial. J Clin Oncol 13:1275-1283, 2018.
- Rischin D, Porceddu S, Day F, et al: Adjuvant cemiplimab or placebo in high-risk cutaneous squamous-cell carcinoma. N Eng J Med 393:774-785, 2025.
- Koyfman SA, Lee JHJ, Mortier L, et al: Phase 3 randomized trial (KEYNOTE-630) of adjuvant pembrolizumab versus placebo for high-risk locally advanced cutaneous squamous cell carcinoma following surgery and radiation. 2025 ASCO Annual Meeting. Abstract 6000. Presented May 31, 2025.
