Certainly, if [the tumor] has been radiated in the past, or if there was a very quick recurrence after prior definitive therapy, all of those factors play a role in how high-risk we consider that lesion to be.
Patient-specific characteristics are also important, such as [ECOG] performance status, functional status, comorbidities, and whether the patient is immunocompromised from another illness or disease state. All of these are very important considerations.
How has the integration of immunotherapy changed multidisciplinary care of CSCC, and how are treatment decisions coordinated across specialties to select the optimal approach for each patient?
CSCC is one of those cancers that benefits tremendously from a multidisciplinary approach. It’s very important that all key stakeholders are aligned around what may be best for the patient in front of us.
Individualizing Treatment Selection in CSCC
- Treatment decisions in CSCC should be tailored to resectability, anatomic location, prior therapy, and patient fitness.
- Surgery remains central when feasible, but functional, cosmetic, and comorbidity considerations may limit operability.
- Multidisciplinary care is increasingly important as immunotherapy expands across adjuvant and advanced settings, particularly for recurrent or unresectable disease.
That often includes dermatology, medical oncology, surgical oncology—sometimes very specific surgeons such as ear, nose, and throat surgeons, Mohs dermatologists, radiation oncologists, and pathologists or dermatopathologists. If we have questions about perineural invasion, lymphovascular invasion, or tumor depth, we often engage pathology colleagues. If there are imaging questions, we involve radiology.
Together, this becomes a robust discussion aimed at achieving consensus on the best approach for that individual patient.
How have longer-term data and the updated label for cosibelimab-ipdl (Unloxcyt) influenced how this agent is used in practice in the advanced setting?1
The agents we currently use in unresectable, advanced, or metastatic CSCC all target the PD-1 axis. Cosibelimab is the newest FDA-approved drug; it’s an anti–PD-L1 antibody, and it also has a dual mechanism involving antibody-dependent cellular cytotoxicity.
How much that second mechanism contributes to cancer cell killing remains unclear, but it differentiates it from agents like cemiplimab-rwlc [Libtayo] or pembrolizumab [Keytruda], which are anti–PD-1 antibodies. Broadly, all of these drugs target the PD-1 axis and allow us to harness the patient’s immune system to fight the cancer. Other options we may consider include cetuximab [Erbitux], chemotherapy, or radiation, depending on the clinical scenario.
What potential clinical benefit could earlier use of cemiplimab in the adjuvant setting offer for improving outcomes before recurrence or progression?2
The phase 3 C-POST trial [NCT03969004] data showed a statistically significant advantage to using cemiplimab in the adjuvant setting, often after radiation. The goal of adjuvant therapy is to proactively reduce the risk of recurrence or metastasis.
The data are intriguing, but not all studies in the adjuvant space have been statistically significant, so this is not a one-size-fits-all approach. It requires honest discussions with patients about the potential benefits and risks. For example, in very frail patients or those with serious autoimmune conditions, PD-1–targeted therapy in the adjuvant setting may not be appropriate.
With immunotherapies being utilized in the adjuvant and advanced settings, how does this affect sequencing and the potential for rechallenge?
That’s another great question, and unfortunately, we don’t yet have definitive answers. As data mature, we’ll better understand outcomes for patients who are rechallenged after recurrence. Based on experience in other cancers, rechallenge may be reasonable depending on timing. If a patient progresses while actively receiving an anti–PD-1 agent, continuing it makes little sense. However, if recurrence occurs many months or years [after completing treatment], rechallenging with a similar agent may be biologically reasonable.
Timing is likely critical, and we’ll learn more as postprogression data from adjuvant trials become available.
As research in CSCC advances, how is the treatment landscape expected to evolve?
We’ll see more combination approaches, often with a PD-1–axis backbone plus another target. CSCC is a highly immunogenic cancer, so further immune-based strategies make sense. We also need to consider sequencing, because more is not always better. If a patient doesn’t respond to PD-1–targeted therapy, what should come next?
Finally, many patients are immunocompromised, which can affect both efficacy and safety. This is an area where we still need better options, especially since only approximately 50% of patients respond to current therapies.
References
- FDA approves label update for Unloxcyt (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced cutaneous squamous cell carcinoma (aCSCC). News release. Sun Pharmaceutical Industries. November 25, 2025. Accessed February 6, 2026. https://sunpharma.com/wp-content/uploads/2025/11/UNLOXCYT-sBLA-Press-Release_FINAL.pdf
- Rischin D, Porceddu S, Day F, et al. Adjuvant cemiplimab or placebo in high-risk cutaneous squamous-cell carcinoma. N Engl J Med. 2025;393(8):774-785. doi:10.1056/NEJMoa2502449